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Link to original content: https://pubmed.ncbi.nlm.nih.gov/27884042
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Review
. 2016 Nov 24;11(11):CD004028.
doi: 10.1002/14651858.CD004028.pub4.

Valproate for schizophrenia

Yijun Wang  1 , Jun Xia, Bartosz Helfer, Chunbo Li, Stefan Leucht
Affiliations
Review

Valproate for schizophrenia

Yijun Wang et al. Cochrane Database Syst Rev. .

Abstract

Background: Many people with schizophrenia do not achieve a satisfactory treatment response with ordinary antipsychotic drug treatment. In these cases, various add-on medications are used, and valproate is one of these.

Objectives: To examine whether:1. valproate alone is an effective treatment for schizophrenia and schizoaffective psychoses; and2. valproate augmentation of antipsychotic medication is an effective treatment for the same illnesses.

Search methods: We searched the Cochrane Schizophrenia Group's Study-Based Register of Trials (July 2002; February 2007; July 2012; March 04, 2016). We also contacted pharmaceutical companies and authors of relevant studies in order to identify further trials.

Selection criteria: We included all randomised controlled trials comparing valproate to antipsychotics or to placebo (or no intervention), whether as the sole agent or as an adjunct to antipsychotic medication for the treatment of people with schizophrenia or schizophrenia-like psychoses.

Data collection and analysis: We independently inspected citations and, where possible, abstracts, ordered papers, and re-inspected and quality-assessed these. At least two review authors independently extracted data. We analysed dichotomous data using risk ratio (RR) and its 95% confidence intervals (CI). We analysed continuous data using mean differences (MD) and their 95% CI. We assessed risk of bias for included studies and used GRADE (Grading of Recommendations Assessment, Development and Evaluation) to create a 'Summary of findings' table.

Main results: The 2012 update search identified 19 further relevant studies, most of which were from China. Thus the review currently includes 26 studies with a total of 2184 participants. All trials examined the effectiveness of valproate as an adjunct to antipsychotics. With the exception of two studies, the studies were small, the participants and personnel were not blinded (neither was outcome assessment), and most were short-term and incompletely reported.For this update we prespecified seven main outcomes of interest: clinical response (clinically significant response, aggression/agitation), leaving the study early (acceptability of treatment, overall tolerability), adverse events (sedation, weight gain) and quality of life.Adding valproate to antipsychotic treatment resulted in more clinically significant response than adding placebo to antipsychotic drugs (14 RCTs, n = 1049, RR 1.31, 95% CI 1.16 to 1.47, I2 = 12%, low-quality evidence). However, this effect was removed after excluding open RCTs in a sensitivity analysis. In terms of acceptability of treatment (measured by the number of participants leaving the study early due to any reason) valproate was just as acceptable as placebo (11 RCTs, n = 951, RR 0.76, 95% CI 0.47 to 1.24, I2 = 55%). Also overall tolerability (measured by the number of participants leaving the study early for adverse events) between valproate and placebo was similar (6 RCTs, n = 974, RR 1.33, 95% CI 0.90 to 1.97, I2 = 0).Participants in the valproate group were found to be less aggressive than the control group based on the Modified Overt Aggression Scale (3 RCTs, n = 186, MD -2.55, 95% CI -3.92 to -1.19, I2 = 82%, very low-quality evidence). Participants receiving valproate more frequently experienced sedation (8 RCTs, n = 770, RR 1.38, 95% CI 1.07 to 1.79, I2 = 0, low-quality evidence) but were no more likely to gain weight than those receiving placebo (4 RCTs, n = 427, RR 1.17, 95% CI 0.76 to 1.82, I2 = 0, low-quality evidence). No study reported on the important outcome of quality of life.

Authors' conclusions: There is limited evidence, based on a number of trials, that the augmentation of antipsychotics with valproate may be effective for overall clinical response, and also for specific symptoms, especially in terms of excitement and aggression. However, this evidence was entirely based on open RCTs. Moreover, valproate was associated with a number of adverse events among which sedation and dizziness appeared significantly more frequently than in the control groups. Further randomised studies which are blinded are necessary before any clear recommendation can be made. Ideally these would focus on people with schizophrenia and aggression, on those with treatment-resistant forms of the illness and on those with schizoaffective disorders.

PubMed Disclaimer

Conflict of interest statement

Yijun Wang: none known.

Jun Xia: none known.

Bartosz Helfer: none known.

Chunbo Li: none known.

Stefan Leucht has received honoraria for lectures from Otsuka, Lundbeck, Janssen, ICON, Lilly, SanofiAventis, AOP Orphan and Servier; for consulting from Janssen, Roche, Lilly, Otsuka, Lundbeck, TEVA and for a publications from Roche.

Figures

1
1
Study flow diagram.
2
2
3
3
4
4
5
5
Funnel plot of comparison: 1 Antipsychotics and valproate versus antipsychotics and placebo/no treatment, outcome: 1.1 Global mental state. 1. Clinically significant response ‐ as defined by the studies
1.1
1.1. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 1 Clinically significant response: 1. Important change ‐ as defined by the studies.
1.2
1.2. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 2 Leaving the study early: Acceptability/tolerability of treatment.
1.3
1.3. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 3 Clinical response: 2. Global state: 1a. mean change score CGI severity (high = poor).
1.4
1.4. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 4 Clinical response: 3. Global state: 1b. mean change score CGI improvement (high = poor).
1.5
1.5. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 5 Clinical response: 4. Mental state: 2a. mean change score PANSS total (high = poor).
1.6
1.6. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 6 Clinical response: 5. Mental state: 2b. mean endpoint score BPRS total (high = poor).
1.7
1.7. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 7 Clinical response: 6. Mental state 2c. mean change score IMPS total (high = poor).
1.8
1.8. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 8 Clincal response: 7. Positive symptoms: 3a. mean endpoint score PANSS positive subscale (high = poor).
1.10
1.10. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 10 Clinical response: 9. Negative symptoms: 4a. mean endpoint score PANSS negative subscale (high = poor).
1.13
1.13. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 13 Clinical response: 12. Negative symptoms: 4d. mean endpoint score BPRS lack of energy subscale (high = poor).
1.14
1.14. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 14 Clinical response: 13. Aggression/Agitation: 5a. clinically important change ‐ Modified Overt Aggression Scale (high = poor).
1.15
1.15. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 15 Clinical response: 14. Aggression/Agitation: 5b. mean endpoint score Modified Overt Aggression Scale (high = poor).
1.16
1.16. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 16 Clinical response: 15. Aggression/Agitation: 5c. mean endpoint score PANSS‐EC subscale (high = poor)).
1.18
1.18. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 18 Clinical response: 17. Aggression/Agitation: 5e. mean endpoint score PANSS supplementary subscale (high = poor).
1.19
1.19. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 19 Clinical response: 18. Aggression/Agitation: 5f. mean endpoint score BPRS hostility subscale (high = poor).
1.20
1.20. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 20 Clinical response: 19. Depression symptoms: 6a. mild improvement at endpoint, Calgary Depression Scale (high = poor).
1.21
1.21. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 21 Clinical response: 20. Depression symptoms: 6b. mean endpoint score BPRS anxiety and depression subscale (high = poor).
1.22
1.22. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 22 Clinical response: 21.General pathology: 7a. mean change score PANSS general pathology subscale (high = poor).
1.25
1.25. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 25 Use of additional medication: 3. Medication for sedation at least once.
1.26
1.26. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 26 Adverse events: 1. Abnormal ECG.
1.27
1.27. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 27 Adverse events: 2. Abnormal liver function/increase in alanine transaminase/gamma‐glutamyl transpeptidase.
1.28
1.28. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 28 Adverse events: 3. Akathisia.
1.29
1.29. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 29 Adverse events: 4. Anxiety.
1.30
1.30. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 30 Adverse events: 5. Asthenia.
1.31
1.31. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 31 Adverse events: 6. Ataxia.
1.32
1.32. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 32 Adverse events: 7. At least one adverse event.
1.33
1.33. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 33 Adverse events: 8. Blood count changes.
1.34
1.34. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 34 Adverse events: 9. Constipation.
1.35
1.35. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 35 Adverse events: 10. Convulsion.
1.36
1.36. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 36 Adverse events: 11. Diarrohea.
1.37
1.37. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 37 Adverse events: 12. Dizziness.
1.38
1.38. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 38 Adverse events: 13. Dry mouth.
1.39
1.39. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 39 Adverse events: 14. Dyspepsia.
1.40
1.40. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 40 Adverse events: 15. Dystonia.
1.42
1.42. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 42 Adverse events: 17. Headache.
1.43
1.43. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 43 Adverse events: 18. Hypersalivation.
1.44
1.44. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 44 Adverse events: 19. Incontinence.
1.45
1.45. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 45 Adverse events: 20. Insomnia.
1.46
1.46. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 46 Adverse events: 21. Myocardial ischaemia.
1.47
1.47. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 47 Adverse events: 22. Nausea.
1.48
1.48. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 48 Adverse events: 23. Pain.
1.49
1.49. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 49 Adverse events: 24. Rash.
1.50
1.50. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 50 Adverse events: 25. Rhinitis.
1.51
1.51. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 51 Adverse events: 26. Rigidity/stiffness.
1.52
1.52. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 52 Adverse events: 27. Sedation/somnolence/drowsiness.
1.53
1.53. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 53 Adverse events: 28. Sexual dysfunction.
1.54
1.54. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 54 Adverse events: 29. Suicidal or depressed.
1.55
1.55. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 55 Adverse events: 30. Tachycardia.
1.56
1.56. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 56 Adverse events: 31.Tremor.
1.57
1.57. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 57 Adverse events: 32. Unstable gait.
1.58
1.58. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 58 Adverse events: 33. Vegetative adverse events.
1.59
1.59. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 59 Adverse events: 34. Vomiting.
1.60
1.60. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 60 Adverse events: 35. Weight gain.
1.61
1.61. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 61 Adverse events: 36. Mean endpoint score TESS (high = poor).
1.62
1.62. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 62 Adverse events: 37. Tardive dyskinesia ‐ mean endpoint score AIMS (high = poor).
1.63
1.63. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 63 Sensitivity analysis: Primary outcome 1. Excluding open studies.
1.64
1.64. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 64 Sensitivity analysis: Primary outcome 2. Fixed‐effect model.
1.65
1.65. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 65 Sensitivity analysis: Primary outcome 3. Exluding no attrition.
1.66
1.66. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 66 Sensitivity analysis: Primary outcome 4. Completers.
1.67
1.67. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 67 Sensitivity analysis: Primary outcome 5. Defined by PANSS reduction.
1.68
1.68. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 68 Sensitivity analysis: Aggresssion/Agitation: 1. Modified Overt Aggression Scale ‐ excluding schizoaffective studies.
1.69
1.69. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 69 Sensitivity analysis: Aggression/Agitation: 2. PANSS‐EC subscale ‐ excluding schizoaffective studies.
1.70
1.70. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 70 Sensitivity analysis: Aggression/Agitation: 3. PANSS supplementary subscale ‐ excluding schizoaffective studies.
1.71
1.71. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 71 Sensitivity analysis: Aggression/Agitation: 4. BPRS hostility subscale ‐ excluding schizoaffective studies.
1.72
1.72. Analysis
Comparison 1 VALPROATE + ANTIPSYCHOTICS versus ANTIPSYCHOTICS + PLACEBO or ANTIPSYCHOTICS alone, Outcome 72 Subgroup analysis: Primary outcome 6. As defined by the studies.
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References

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Liu 2007a {published data only}
    1. Liu Z. Sodium valproate in treatment of aggression for psychiatric participants [丙戊酸钠治疗精神病患者的攻击行为]. Chongqing Journal of Medicine [重庆医学杂志] 2007;36(6):490‐1.
Lu 2006 {published data only}
    1. Lu W, Jin W, Wang H, Ma Y, Tong Z. Comparing study of sodium valproate xr (Depakine) in the supplementary therapy of excitement state in participants with schizophrenia and schizoaffective disorder. Proceedings of the Zhejiang Annual Psychiatry Conference, Yiwu, China. 2005:75‐7.
    1. Lu WM, Jin WD, Shen Y, Ma YC, Tong ZH. Clinical evaluation of sodium valproate xr (Depakine) in adjunctive therapy for participants with excitomania associated with schizophrenia and schizoaffective disorder. Chinese New Drugs Journal 2006;15(15):1291‐3.
Pan 2010 {published data only}
    1. Pan ZX, Yin DF, Liu NH. Sodium valproate combined clozapine in the treatment of refractory schizophrenia 34 cases [丙戊酸钠联合氯氮平治疗难治性精神分裂症34例]. Herald of Medicine [医学导报] 2010;29(2):203‐4.
Shi 2010 {published data only}
    1. Shi YX, Dai TG, Yi PC. A study of olanzapine combined with magnesium valproate sustained‐release tablets for the treatment of excitement and agitation in acute phase of schizophrenia [奥氮平合并丙戊酸镁缓释片治疗精神分裂症急性期兴奋激越研究]. Modern Practical Medicine [现代实用医学] 2010;22(4):398‐9.
Wang 2005a {published data only}
    1. Wang H. Combination of magnesium valproate and anti‐psychotics in aggressive behaviors of schizophrenics. Journal of Clinical Psychosomatic Diseases 2005;11(1):10‐1. [113903]
Wang 2009 {published data only}
    1. Wang GP, Xie R, Pei GX, Zhang XJ. The effect of adjuvant magnesium valproate sustained‐release tablets in the treatment of schizophrenia [丙戊酸镁缓释片治疗精神分裂症的辅助作用]. Journal of Clinical Psychiatry [临床精神医学杂志] 2009;19(4):250‐1.
Wang 2010 {published data only}
    1. Wang LJ, Zhang J. A comparative study of sodium valproate combined with other drugs for schizophrenia with impulsive and aggressive behavior [合用丙戊酸钠治疗伴有冲动和攻击行为的精神分裂症的对照研究]. Medical Journal of Chinese People's Health [中国民康医学] 2010;22(5):548‐9.
Wassef 2000 {published data only}
    1. Wassef AA, Dott SG, Harris A, Brown A, O'Boyle M, Meyer WJ 3rd, et al. Randomized, placebo‐controlled pilot study of divalproex sodium in the treatment of acute exacerbations of chronic schizophrenia. Journal of Clinical Psychopharmacology 2000;20(3):357‐61. [MEDLINE: ] - PubMed
Xie 2011 {published data only}
    1. Xie R, Wang G, Pei G. The effect of adjuvant magnesium valproate sustained‐release tablet in the treatment of schizophrenic participants with aggressive behaviours [丙戊酸镁缓释片辅助治疗精神分裂症攻击行为的疗效观察]. Journal of Clinical Psychiatry [临床精神医学杂志] 2011;21(3):191‐2.
Yao 2010 {published data only}
    1. Yao F, Jiang F. Short‐term efficacy of risperidone combined with magnesium valproate sustained‐release tablets in the treatment of schizophrenia with aggressive behavior [利培酮联合丙戊酸镁缓释片治疗精神分裂症攻击行为的近期疗效]. Occupation and Health [职业与健康] 2010;26(22):2713‐4.
Yin 2004 {published data only}
    1. Yin XR, Xie BQ, Jiang L. A double‐blind comparative study of sodium valproate in treating of TD. Journal of Clinical Psychological Medicine 2004;14(2):92‐3. [113903]
Zhang 2007 {published data only}
    1. Zhang SL, Wang CX, Wang LT, Feng YF. The effect of debakin combined with risperidone in the treatment of schizophrenia with psychmotor excitement [德巴金联合利培酮治疗伴精神运动性兴奋的精神分裂症的效果]. Medical Journal of Qilu [齐鲁医学杂志] 2007;22(3):265‐6.

References to studies excluded from this review

Alberti 1999 {published data only}
    1. Alberti GG, Garini R, Marzolini M, Beltz J, Greco MI, Maresca G. Efficacy and tolerability of gabapentin (GBP) and valproate (VPA) as an adjunct in the neuroleptic treatment of acute manic syndromes. Journal of the European College of Neuropsychopharmacology 1999;9:210.
Bersudsky 2010 {published data only}
    1. Bersudsky Y, Applebaum J, Gaiduk Y, Sharony L, Mishory A, Podberezsky A, et al. Valnoctamide as a valproate substitute with low teratogenic potential in mania: a double‐blind, controlled, add‐on clinical trial. Bipolar Disorders 2010;12(4):376‐82. - PubMed
Centorrino 1994 {published data only}
    1. Centorrino F, Baldessarini RJ, Kando J, Frankenburg FR, Volpicelli SA, Puopolo PR, et al. Serum concentrations of clozapine and its major metabolites: effects of co‐treatment with fluoxetine or valproate. American Journal of Psychiatry 1994;151(1):123‐5. [MEDLINE: ] - PubMed
Haupt 2007 {published data only}
    1. Haupt DW, Fahnestock PA, Hessler MJ, Flavin K, Bagley S, Yingling M, et al. Changes in direct measures of adiposity in schizophrenia participants during divalproex augmentation of antipsychotic treatment. Schizophrenia Bulletin 2007;33(2):501.
Ma 2010 {published data only}
    1. Ma XW. The effect of adjuvant magnesium valproate in the treatment of schizophrenia [丙戊酸镁对精神分裂症的辅助治疗作用]. China Practical Medicine [中国实用医药] April 2010;5(12):43‐4.
Monfort 1991 {published data only}
    1. Monfort JC, Mager C, Thorpe D, Ropert R, Ferrey G, Mentre F, et al. Valproate‐diazepam combination versus chlorpromazine: a double‐blind study in schizophrenic and schizophreniform disorders [Valproate‐diazépam versus chlorpromazine: étude en double aveugle dans les troubles schizophréniques et schizophréniformes]. Encephale 1991;17(2):101. [MEDLINE: ]
NCT00183443 {published data only}
    1. NCT00183443. Divalproex extended release and placebo, lithium, or quetiapine for mania. clinicaltrials.gov/ct2/show/NCT00183443 [Date Accessed: 13 September 2005].
Ping 1994 {published data only}
    1. Ping Y, Xinjuan OY, Lin T. A controlled study of sodium valproate and chlorpromazine for schizophrenia. Shanghai Archives of Psychiatry 1994;6(4):208‐9.
Raja 2000 {published data only}
    1. Raja M, Azzoni A. Second generation antipsychotics in the emergency care setting. A prospective naturalistic study. General Hospital Psychiatry 2000;22(2):107‐14. [MEDLINE: ] - PubMed
Rifang 2001 {published data only}
    1. Rifang C, Fenfang Z. The impact of sodium valproate for social function rehabilitation in schizophrenia participants. Modern Rehabilitation 2001;5(9):100.
Zhu 2005 {published data only}
    1. Zhu C, Fu R, Yang Y. Sodium valproate and clonazepam for the treatment of agitated symptoms of participants with schizophrenia: a controlled trial. Medical Journal of the Chinese People's Armed Police Forces 2005;16(12):934‐5. [CAJ MEDI0602]

References to studies awaiting assessment

Boylan 2004 {published data only}
    1. Boylan L, Labovitz D. Unbalanced statistical analysis of combined divalproex and antipsychotic therapy for schizophrenia. Neuropyschopharmacology. United States of America, 2004; Vol. 29, issue 3:636. - PubMed
Chien 1978 {published data only}
    1. Chien C, Jung K, Ross‐Townsend A. Efficacies of agents related to GABA, dopamine, and acetylcholine in the treatment of tardive dyskinesia. Psychopharmacology Bulletin 1978; Vol. 14, issue 2:20‐2. - PubMed
Cui 2012 {published data only}
    1. Cui LJ, Shen WM. Effects of magnesium valproate treatment on weight and blood insulin levels in patients with schizophrenia [丙戊酸镁对精神分裂症患者体重及胰岛素水平的影响]. Frontiers of Medicine [医药前沿] 2012; Vol. 22:97.
Ellenor 1995 {published data only}
    1. Ellenor G, Lohr J, Ito M, Dishman B, Gammariello A. The comparative efficacy of divalproex low and high serum level in bipolar disorder and schizophrenia. Psychopharmacology Bulletin 1995; Vol. 31, issue 3:563.
Friis 1983 {published data only}
    1. Friis T, Christensen TR, Gerlach J. Sodium valproate and biperiden in neuroleptic‐induced akathisia, parkinsonism and hyperkinesia. A double‐blind cross‐over study with placebo. Acta Psychiatrica Scandinavica 1983;67(3):178‐87. [MEDLINE: ] - PubMed
Gong 2010 {published data only}
    1. Gong Y, Guo P. Effects of magnesium valproate on cognitive function in patients with refractory schizophrenia [丙戊酸镁对难治性精神分裂症患者认知功能的影响]. Chronic Pathematology Journal [慢性病学杂志] 2010; Vol. 12, issue 2:107‐9.
Gu 2012 {published data only}
    1. Gu P, Wang J, Cao J, Li B‐z. A comparative study of quetiapine with sustained‐release tablets of magnesium valproate in treatment of old patients with acute phase of schizophrenia [奎硫平合并丙戊酸镁治疗老年精神分裂症急性期的对照研究]. Chinese Journal of Clinical Psychology [中国临床心理学杂志] 2012; Vol. 20, issue 4:520‐2.
Gu 2014 {published data only}
    1. Gu Q. Prognostic analysis of magnesium valproate combined with antipsychotics for patients with convalescent schizophrenia [丙戊酸镁联合抗精神病药物治疗对恢复期精神分裂症患者的预后分析]. Medical Journal of Chinese People's Health [中国民康医学] 2014; Vol. 26, issue 18:59, 99.
Huang 2013 {published data only}
    1. Huang WD, Luo HF, Lan L, Li CH, Xu LH, Li ZM. Efficacy of ziprasidone combined with low‐dose sodium valproate in the treatment of female refractory schizophrenia [齐拉西酮联合小剂量丙戊酸钠治疗女性难治性精神分裂症疗效分析]. Youjiang Medical Journal [右江医学] 2013, issue 02:159‐62.
Jiang 2014 {published data only}
    1. Jiang TC, Xiong Y. Efficacy of quetiapine combined with sodium valproate in the treatment of schizophrenia with impulsive and aggression in female patients [喹硫平联合丙戊酸钠治疗女性精神分裂症患者冲动攻击行为的疗效观察]. World Latest Medicine Information [世界最新医学信息文摘（连续型电子期刊）] 2014; Vol. 14, issue 32:79‐80.
Jin 2013 {published data only}
    1. Jin G. Efficacy of magnesium valproate for schizophrenia with impulsive and aggressive behavior [丙戊酸镁对精神分裂症冲动攻击行为疗效观察]. Chinese Journal of Modern Drug Application [中国现代药物应用] 2013, issue 14:160‐1.
Lee 1996 {published data only}
    1. Lee MS, Choi BH, Kim SH. Combined use of carbamazepine and valproic acid in negative symptom schizophrenia. 9th Congress of the European College of Neuropsychopharmacology; 1996 Sep 21‐25; Amsterdam, The Netherlands. 1996. [MEDLINE: ]
Li 2008a {published data only}
    1. Li W, Yu X, Cui Y. A comparative study of olanzapine with small‐dose sustained‐release tablets of magnesium valproate in treatment of acute phase of schizophrenia. Shandong Archives of Psychiatry 2008;21(3):178‐9.
Li 2012a {published data only}
    1. Li DM. Clinical efficacy of ziprasidone combined with valproate in the treatment of refractory schizophrenia [齐拉西酮联合丙戊酸钠治疗难治性精神分裂症的临床疗效观察]. China Medical Engineering [中国医学工程] 2012, issue 01:92‐3.
Li 2013 {published data only}
    1. Li C, Liu Y, Wang M. The effect of adjuvant magnesium valproate sustained‐release tablets combined with risperidone in the treatment of schizophrenia with impulsive aggression [丙戊酸镁缓释片合用利培酮对精神分裂症冲动攻击行为的辅助治疗]. Journal of Practical Medical Techniques [实用医技杂志] 2013, issue 01:69‐71.
Li 2013a {published data only}
    1. Li J, Chen LS, Chen Wang Y. A comparative study of effect of sodium valproate on cognitive dysfunction in patients with schizophrenia [丙戊酸钠改善精神分裂症患者认知功能障碍的对照研究]. Journal of Psychiatry [精神医学杂志] 2013, issue 04:292‐4.
Li 2014 {published data only}
    1. Li YM, Sun WB, Yang CQ. A study of low‐dose quetiapine combined with magnesium valproate in the treatment of schizophrenia [低剂量喹硫平合并丙戊酸镁治疗精神分裂症攻击行为疗效研究]. Medical Information [医学信息] 2014; Vol. 27, issue 24:47‐8.
Li 2014a {published data only}
    1. Li Y. A comparative study of antipsychotic drugs combined with low‐dose sodium valproate in the treatment of schizophrenia [抗精神病药物联合小剂量丙戊酸镁治疗精神分裂症攻击行为的对照研究]. The Chinese and Foreign Health Abstract [中外健康文摘] 2014, issue 11:53.
Liang 2004a {published data only}
    1. Liang H‐X, Du J‐Y, Wu Z‐J. A study of additive effect of sodium‐valproate in the treatment of schizophrenia. Journal of Clinical Psychological Medicine 2004;14(2):92‐3.
Linnoila 1976a {published data only}
    1. Linnoila M, Viukari M, Kietala O. Effect of sodium valproate on tardive dyskinesia. British Journal of Psychiatry 1976;129:114‐9. [MEDLINE: ] - PubMed
Linnoila 1976b {published data only}
    1. Linnoila M, Viukari M, Hietala O. Sodium valproate therapy for tardive dyskinesia. International Drug Therapy Newsletter 1976;11(Nov):33‐5. [MEDLINE: ]
Liu 2007b {published data only}
    1. Liu Z. Sodium valproate in treatment of aggression of psychiatric participants [丙戊酸钠治疗精神病患者的攻击行为]. Chongqing Medical Journal [重庆医学] 2007;36(6):490‐1.
Liu 2012 {published data only}
    1. Liu Z, Wang L, Sun Y. Clinical observation of magnesium valproate sustained‐release tablets for schizophrenia with excitement [丙戊酸镁缓释片对精神分裂症兴奋状态的疗效观察]. China Journal of Health Psychology [中国健康心理学杂志] 2012; Vol. 20, issue 11:1630‐1.
Liu 2012a {published data only}
    1. Liu J. The effect of adjuvant magnesium valproate on schizophrenia with aggressive behavior [丙戊酸镁对精神分裂症兴奋激越行为的辅助疗效观察]. Journal of Community Medicine [社区医学杂志] 2012; Vol. 10, issue 14:31‐2.
Liu 2013 {published data only}
    1. Liu Z, Song S, Wang L. Effects of magnesium valproate sustained‐release tablets combined with risperdal on lipid metabolism in patients with schizophrenia [丙戍酸镁缓释片合并维思通对精神分裂症患者脂代谢影响]. China Journal of Health Psychology [中国健康心理学杂志] 2013; Vol. 21, issue 11:1631‐2.
Liu 2014 {published data only}
    1. Liu Z, Li HJ, Pei SY. Effects of risperidone and magnesium valproate on blood concentration in patients with schizophrenia [丙戍酸镁合并利培酮治疗精神分裂症血药浓度变化及临床疗效]. China Journal of Health Psychology [中国健康心理学杂志] 2014; Vol. 22, issue 8:1141‐3.
Lv 2014 {published data only}
    1. Lv S. Effects of magnesium valproate sustained‐release tablets on cognitive function in first‐episode schizophrenic patients [丙戊酸镁缓释片对首发精神分裂症病人认知功能的影响]. China & Foreign Medical Treatment [中外医疗] 2014, issue 17:120‐1.
Ma 2012 {published data only}
    1. Ma TB. Analysis of effects of valproic acid sodium jointed with ziprasidone in the treatment of refractory schizophrenia [丙戊酸钠联合齐拉西酮治疗难治性精神分裂症的效果分析]. China Modern Medicine [中国当代医药] 2012, issue 04:73‐4.
Monteleone 1986 {published data only}
    1. Monteleone P, Maj M, Iovino M, Steardo L. Growth hormone response to sodium valproate in chronic schizophrenia. Biological Psychiatry 1986; Vol. 21, issue 7:588‐94. - PubMed
Monteleone 1988 {published data only}
    1. Monteleone P, Maj M, Ariano M, Iovino M, Fiorenza L, Steardo L. Prolactin response to sodium valproate in schizophrenics with and without tardive dyskinesia. Psychopharmacology 1988; Vol. 96, issue 2:223‐6. - PubMed
Nair 1980 {published data only}
    1. Nair N, Lal S, Schwartz G. Effect of sodium valproate and baclofen in tardive dyskinesia: clinical and neuroendocrine studies. In: Cattabeni FRG editor(s). Long Term Effects of Neuroleptics. Advances in Biochemistry and Psychopharmacology. Vol. 24, New York, USA: Raven Press, 1980:437‐41. - PubMed
Nasrallah 1986 {published data only}
    1. Nasrallah H, Dunner F, McCalley Whitters M, Smith R. Pharmacologic probes of neurotransmitter systems in tardive dyskinesia: implications for clinical management. Journal of Clinical Psychological Medicine. United‐States, 1986; Vol. 47, issue 2:56‐9. - PubMed
NCT00552500 {published data only}
    1. NCT00552500. Effects of atypical antipsychotic and valproate combination therapy on glucose and lipid metabolism in schizophrenia. clinicaltrials.gov/ct2/show/NCT00552500 [Date Accessed: 1 November 2007].
Peng 2012 {published data only}
    1. Peng ZY, Xia CL, Liu XM. A comparative study of clozapine and clozapine unite magnesium valproate in the treatment of patients with treatment‐resistant schizophrenia [氯氮平合并丙戊酸镁治疗难治性精神分裂症的对照研究]. World Health Digest Medical Periodieal [中外健康文摘] 2012; Vol. 38:164‐6.
Peng 2013 {published data only}
    1. Peng H. Effect of magnesium valproate on aggressive behavior in schizophrenia [丙戊酸镁对精神分裂症攻击行为的疗效观察]. Chinese Journal of Trauma and Disability Medicine [中国伤残医学] 2013, issue 07:187‐8.
Pu 2013 {published data only}
    1. Pu QX, Wu HB, Huang X, Yu GH, Wang DF, Gu ZW, et al. Contrast analysis of olanzapine combined with sodium valproate on refractory schizophrenia [奥氮平合并丙戊酸钠治疗难治性精神分裂症的对照分析]. Progress in Modern Biomedicine [现代生物医学进展] 2013, issue 18:3503‐6.
Qiu 2014 {published data only}
    1. Qiu LL, Wang JF. Effect of sodium valproate on risperidone therapy and blood concentration [丙戊酸镁对利培酮疗效及血药浓度的影响]. Medical Journal of Liaoning [辽宁医学杂志] 2014; Vol. 28, issue 1:9‐10.
Qu 2014 {published data only}
    1. Qu CH, Liu XL, Sun XH. A comparative study of valproate combined with olanzapine in the treatment of schizophrenia [丙戊酸钠合用奥氮平治疗精神分裂症患者攻击行为的对照研究]. Medical Information [医学信息] 2014; Vol. 27, issue 21:602.
Ruiz‐Doblado 2010 {published data only}
    1. Ruiz‐Doblado S, Baena‐Baldomero A, Esparrago‐Llorca G. Pharmacological augmentation strategies in clozapine‐resistant schizophrenia: overcoming the resistance. Psiquiatria Biologica 2010;17(3):96‐101.
Shu 2014 {published data only}
    1. Shu Z, Zhou W. Clinical observation of clozapine combined with magnesium valproate sustained‐release tablets in the treatment of schizophrenia [氯氮平联合丙戊酸镁缓释片治疗精神分裂症攻击行为的疗效观察]. Guide of China Medicine [中国医药指南] 2014; Vol. 12, issue 2:28‐9.
Su 2013 {published data only}
    1. Su L, Xu Y, Shi S, Dutt A, Bramon E. Effects of chlorpromazine, clozapine and valproate on auditory P300 in schizophrenia: a prospective longitudinal randomized controlled study. Schizophrenia Bulletin 2013; Vol. 39:S51.
Sun 2007 {published data only}
    1. Sun Q, Quo H, Zhang H, Liu Y, Zhu Y, Zhang A. The effects of magnesium valproate sustained release tablets on the cognitive function in treatment‐resistant schizophrenic participants. Proceedings of the Shanghai Regional Meeting and CSP Annual Congress; 2007 Sep 20‐23; Shanghai. 2007.
Sun 2008 {published data only}
    1. Sun Q‐X, Guo H, Liu Y. Effect of magnesium valproate sustained release tablets on cognition function in difficult cure sex schizophrenic. Chinese Journal of Modern Drug Application [中国现代药物应用] 2008;2(22):25‐7.
Sun 2012 {published data only}
    1. Sun XG. A comparative study of quetiapine combined with haloperidol, sodium valproate and clozapine in the treatment of refractory schizophrenia [奎硫平合并氟哌啶醇、丙戊酸钠与氯氮平治疗难治性分裂症对照研究]. Medical Journal of Chinese People's Health [中国民康医学] 2012; Vol. 24, issue 13:1566‐7.
Suzana 2009 {published data only}
    1. Suzana S, Olivera Z, Gordana N, Violeta S, Dragoslava G, Vladica S. Adjunctive mood stabilising treatment: the effects on hostility and impulsivity among patients with schizophrenia. European Neuropsychopharmacology 2009; Vol. 19:S532.
Tang 2012 {published data only}
    1. Tang SY, Qin CL, Zhang W, Xiong MQ. Clinical observation of sodium valproate sustained‐release tablets on schizophrenia hostile attack [丙戊酸钠治疗精神分裂症敌意攻击行为疗效观察]. J Medical Forum [医药论坛杂志] 2012; Vol. 9:36‐7.
Wang 2005b {published data only}
    1. Wang H. Combination of magnesium valproate and anti‐psychotics in aggressive behaviors of schizophrenics. Journal of Clinical Psychosomatic Diseases 2005;11(1):10‐1.
Wang 2006 {published data only}
    1. Wang HL. Therapeutic effect of risperidone combined with magnesium valproate in aggressive behaviors of schizophrenics. Chinese Journal of Health Psychology 2006;14(4):441‐2.
Wang 2012 {published data only}
    1. Wang G, Xie R, Pei G. A comparative study of quetiapine combined with magnesium valproate sustained‐release tablets in the treatment of schizophrenia with aggressive behavior [喹硫平合并丙戊酸镁缓释片治疗精神分裂症攻击行为的对照研究]. Journal of Psychiatry [精神医学杂志] 2012, issue 01:59‐60.
Wang 2013 {published data only}
    1. Wang Y. Efficacy of olanzapine combined with magnesium valproate in the treatment of schizophrenia [奥氮平合用丙戊酸镁缓释片治疗精神分裂症疗效分析]. Chinese Journal of General Practice [中华全科医学] 2013, issue 05:730+749.
Wang 2013a {published data only}
    1. Wang ML, Jiang TC. Clinical observation of risperidone combined with sodium valproate in the treatment of schizophrenia with impulse and aggressive behavior [利培酮联合丙戊酸钠治疗伴有冲动和攻击行为的精神分裂症患者的临床观察]. Clinical Rational Drug Use [临床合理用药杂志] 2013, issue 01:72‐3.
Wang 2014 {published data only}
    1. Wang GL, Fu PX, Li XY, Lin JX, Ji QS, Li ZJ. A comparative study of the efficacy of risperidone combined with valproate sodium on the aggressive behavior of the patients with schizophrenia [利培酮合并丙戊酸钠对精神分裂症患者攻击行为疗效的对照研究]. Chinese Journal of Drug Abuse Prevention and Treatment [中国药物滥用防治杂志] 2014; Vol. 20, issue 4:200‐2.
Wang 2014a {published data only}
    1. Wang ZB. The effect of adjuvant sodium valproate for schizophrenia with behavioral disorders [丙戊酸钠对精神分裂症行为紊乱的辅助治疗作用]. Medical Journal of Chinese People's Health [中国民康医学] 2014; Vol. 26, issue 22:57‐8.
Wen 2013 {published data only}
    1. Wen J, Li Y, Wang G. Clinical efficacy and safety of quetiapine combined with magnesium valproate in the treatment of schizophrenia with aggressive behavior [喹硫平合并丙戊酸镁缓释片治疗具有攻击行为精神分裂症的临床疗效及安全性探讨]. Medical Journal of Chinese Civil Administration [中国民康医学] 2013, issue 11:55‐6.
Wu 2013a {published data only}
    1. Wu J, Lin T. Efficacy of magnesium valproate combined with quetiapine in the treatment of refractory schizophrenia [丙戊酸镁联合喹硫平治疗难治性精神分裂症的疗效研究]. Practical Journal of Cardiac Cerebral Pneumal and Vascular Disease [实用心脑肺血管病杂志] 2013, issue 04:140‐1.
Wu 2013b {published data only}
    1. Wu X, Yang Q, Zhang L, Zhou S. A comparative study of olanzapine combined with magnesium valproate sustained‐release tablets in the treatment of patients with positive symptoms of schizophrenia [奥氮平联合丙戊酸镁缓释片治疗精神分裂症伴阳性症状患者的对照研究]. Medical Journal of West China [西部医学] 2013, issue 12:1842‐4.
Xiao 2013 {published data only}
    1. Xiao H. A retrospective study of risperidone combined with magnesium valproate in the treatment of schizophrenia [利培酮合并丙戊酸镁治疗精神分裂症用药现状回顾分析]. Nei Mongol Journal of Traditional Chinese Medicine [内蒙古中医药] 2013, issue 06:30‐1.
Xu 2002 {published data only}
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Xu 2013 {published data only}
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References to ongoing studies

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