Intervention Review

Haloperidol alone or in combination for acute mania

  1. Andrea Cipriani1,*,
  2. Jennifer M Rendell2,
  3. John Geddes2

Editorial Group: Cochrane Depression, Anxiety and Neurosis Group

Published Online: 19 JUL 2006

Assessed as up-to-date: 22 MAY 2006

DOI: 10.1002/14651858.CD004362.pub2

How to Cite

Cipriani A, Rendell JM, Geddes J. Haloperidol alone or in combination for acute mania. Cochrane Database of Systematic Reviews 2006, Issue 3. Art. No.: CD004362. DOI: 10.1002/14651858.CD004362.pub2.

Author Information

  1. 1

    University of Verona, Department of Medicine and Public Health, Section of Psychiatry and Clinical Psychology, Verona, Italy

  2. 2

    University of Oxford, Department of Psychiatry, Oxford, UK

*Andrea Cipriani, Department of Medicine and Public Health, Section of Psychiatry and Clinical Psychology, University of Verona, Policlinico "G.B.Rossi", Piazzale L.A. Scuro, 10, Verona, 37134, Italy.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 19 JUL 2006




  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要


The main objectives in treating mania are to control dangerous behaviour, reduce suicide, produce appropriate acute sedation and shorten the episode of mood disturbance. Among different drugs, haloperidol has for many years been used in treating psychotic patients, but it has a troublesome side effect profile.


To assess the effects of haloperidol for the treatment of mania in comparison with placebo or other active drugs, either as monotherapy or add-on treatment.

Search methods

We searched the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (11 October 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2005), MEDLINE (1966-2003), EMBASE (1980-2003), CINAHL (1982-2003), PsycINFO (1872-2003) and reference lists. We also contacted experts, triallists and pharmaceutical companies in the field.

Selection criteria

Randomised trials comparing haloperidol with placebo or other active treatment in the treatment of acute manic or mixed episodes in patients with bipolar disorder or schizoaffective disorder.

Data collection and analysis

Two authors independently assessed trial quality and extracted data. We contacted study authors for additional information. We collected adverse effects information from the trials.

Main results

Fifteen trials involving 2022 people were included. Compared to placebo, haloperidol was more effective at reducing manic symptoms, both as monotherapy (Weighted Mean Difference (WMD) -5.85, 95% Confidence Interval (CI) -7.69 to -4.00) and as adjunctive treatment to lithium or valproate (WMD -5.20, 95% CI -9.26 to -1.14). There was a statistically significant difference, with haloperidol being less effective than aripiprazole (Relative Risk (RR) 1.45, 95% CI 1.22 to 1.73). No significant differences between haloperidol and risperidone, olanzapine, carbamazepine or valproate were found. Compared with placebo, a statistically significant difference in favour of haloperidol in failure to complete treatment (RR 0.74, 95% Cl 0.57 to 0.96) was reported. Haloperidol was associated with less weight gain than olanzapine (RR: 0.28, 95% CI 0.12 to 0.67), but with a higher incidence of tremor (RR: 3.01, 95% CI 1.55 to 5.84) and other movement disorders.

Authors' conclusions

There is some evidence that haloperidol is an effective treatment for acute mania. From the limited data available, there was no difference in overall efficacy of treatment between haloperidol and olanzapine or risperidone. Some evidence suggests that haloperidol could be less effective than aripiprazole. Referring to tolerability, when considering the poor evidence comparing drugs, clinicians and patients should consider different side effect profiles as an important issue to inform their choice.


Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Haloperidol alone or in combination for the treatment of mania

Fifteen trials met the inclusion criteria and are included in the review. Interpretation of the results was hindered by the small total sample size and by the low quality of reporting of the included trials. There was some evidence that haloperidol was more efficacious than placebo in terms of reduction of manic and psychotic symptom scores, when used both as monotherapy and as add-on treatment to lithium or valproate. There is no evidence of difference in efficacy between haloperidol and risperidone, olanzapine, valproate, carbamazepine, sultopride and zuclopentixol. There was a statistically significant difference with haloperidol being probably less effective than aripiprazole. No comparative efficacy data with quetiapine, lithium or chlorpromazine were reported. Haloperidol caused more extrapyramidal symptoms (EPS) than placebo and more movement disorders and EPS but less weight gain than olanzapine. Haloperidol caused more EPS than valproate but no difference was found between haloperidol and lithium, carbamazepine, sultopride and risperidone in terms of side effects profile.



  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要







我們搜查了考科藍憂鬱,焦慮和神經官能症註冊的對照試驗(2005年10月11) ,考科藍對照試驗註冊中心(考科藍圖書館主題三, 2005年),MEDLINE(1966年至2003年),EMBASE(1980年至2003年), CINAHL(1982年至2003年), psycinfo (1872年至2003年)和參考文獻清單。我們還接觸了專家,試驗清單和該領域的製藥公司。






15個研究有2022人包括在內。和安慰劑相比,無論是作為單一治療(加權平均差異(WMD)−5.85 , 95 %信賴區間(CI)−7.69到−4.00)或作為鋰鹽或Valproate的輔助治療(加權平均差異(WMD)−5.2, 95 %信賴區間 CI為−9.26到−1.14) haloperidol能更有效的減少躁狂的症狀。與 aripiprazole相比, haloperidol效果較差,呈現統計上顯著性差異(相對危險(RR):1.45 , 95 % 信賴區間為1.22至1.73)。與risperidone, olanzapine, carbamazepine 或 valproate相比,則無顯著差異。與安慰劑相比,統計學呈現顯著性差異,haloperidol組較無法完成治療(RR 0.74 , 95 %信賴區間0.57至0.96)。Haloperidol 與olanzapine 相比較少體重增加(RR : 0.28,95 %信賴區間為0.12至0.67),但具有較高震顫的發生率(RR : 3.01,95%信賴區間為1.55至5.84)及其他運動障礙的發生率。


有一些證據顯示haloperidol是一種有效的治療急性躁狂症的藥物。從有限的資料看來,在整體效果上, haloperidol及olanzapine或risperidone並無差異。有一些證據顯示, haloperidol可能不像aripiprazole那麼有效。有關耐受性方面,當考慮到與其他藥物比較的證據不足時,臨床醫生和病人應考慮不同的副作用概況作為選擇的依據。



此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。


這項回顧考慮到比較haloperidol與安慰劑或其他活性藥物治療躁症的療效,接受度及副作用. 有15個研究符合納入標準,並列入回顧。結果的判讀會因總樣本太小和納入研究的低品質報告而有所阻礙。有一些證據顯示,無論是作為單一治療或作為鋰鹽或Valproate的輔助治療,與安慰劑比較起來,在減少躁狂和精神病症狀量表分數方面,haloperidol較有效。目前並無證據顯示haloperidol與risperidone, olanzapine, valproate, carbamazepine, sultopride and zuclopentixol有療效上的差異。在療效上, haloperidol比aripiprazole在統計學上顯著較差。沒有跟quetiapine, lithium 或chlorpromazine 的療效比較報導。Haloperidol比安慰劑造成更多的錐體外症狀(EPS)和更多的運動障礙,但比olanzapine較少體重增加。Haloperidol比valproate導致更多的錐體外症狀(EPS),但haloperidol與lithium, carbamazepine, sultopride及risperidone 之間並無副作用的差別.