Magnitude of effect of lithium in short-term efficacy studies of moderate to severe manic episode

Bipolar Disorders

Volumn 9, Issue 8, 2007, Pages 793-798

  Storosum, Jitschak G ^a,b   Wohlfarth, Tamar ^a   Schene, Aart ^b   Elferink, Andre ^a   van Zwieten, Barbara J ^a   van den Brink, Wim ^b  

^a MEDICINES EVALUATION BOARD   (Netherlands)

^b UNIVERSITY OF AMSTERDAM   (Netherlands)

Author keywords

Lithium; Manic episode; Meta analysis; Short term treatment

Indexed keywords

BENZODIAZEPINE; CHLORAL HYDRATE; HALOPERIDOL; LITHIUM; LORAZEPAM; PLACEBO;

ACCURACY; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; GENERAL CONDITION IMPROVEMENT; HUMAN; MANIA; META ANALYSIS; PRIORITY JOURNAL; PROGNOSIS; PSYCHOPHARMACOTHERAPY; RANDOMIZED CONTROLLED TRIAL; REVIEW; STANDARDIZATION; SYSTEMATIC REVIEW; TREATMENT RESPONSE;

ANTIMANIC AGENTS; BIPOLAR DISORDER; CLINICAL TRIALS DATA MONITORING COMMITTEES; DATABASES, FACTUAL; DOUBLE-BLIND METHOD; HUMANS; LITHIUM; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RETROSPECTIVE STUDIES;

EID: 36749072086     PISSN: 13985647     EISSN: 13995618     Source Type: Journal    
DOI: 10.1111/j.1399-5618.2007.00445.x     Document Type: Review

References (27)

1. Fountoulakis KN, Vieta E, Sanchez-Moreno J, Kaprinis SG, Goikolea JM, Kaprinis GS. Treatment guidelines for bipolar disorder: A critical review. J Affect Disord 2005; 86: 1-10.
2. Bowden CL. Efficacy of lithium in mania and maintenance therapy of bipolar disorder. J Clin Psychiatry 2000; 61 (Suppl. 9): 35-40.
3. European Agency for the Evaluation of Medicinal Products. Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment and Prevention of Bipolar Disorder. Evaluation of Medicines for Human Use. CPMP/EWP/567/98. London: European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products (CPMP), 2001. http://www.emea.eu.int/pdfs/human/ewp/ 056798en.pdf (Accessed November 29, 2006).
4. European Agency for the Evaluation of Medicinal Products. Note for Guidance on Choice of Control Group in Clinical Trials. CPMP/ICH/346/96 ICH Topic E 10. London: European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products (CPMP), 2000. http://www.emea.eu.int/pdfs/human/ich/036496en.pdf (Accessed November 29, 2006).
5. European Agency for the Evaluation of Medicinal Products. Note for Guidance on Good Clinical Practice. CPMP/ICH/135/95. London: European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products (CPMP), 2000. http://www.emea.eu.int/pdfs/ human/ich/013595en.pdf (Accessed November 29, 2006).
6. Cohen J. Statistical Power Analysis for the Behavioral Sciences, Second edn. Hillsdale, NJ: Lawrence Erlbaum Associates, 1988: 20-26.
7. Centre for Evidence-based Medicine, Department of Medicine Toronto General Hospital. 2004. http://www.cebm.utoronto.ca/glossary (Accessed November 29, 2006).
8. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials 1996; 7: 177-188.
9. Bowden CL, Brugger AM, Swann AC et.al. Efficacy of divalproex vs lithium and placebo in the treatment of mania. The Depakote Mania Study Group. JAMA 1994; 271: 918-924 (Erratum: JAMA 1994; 271: 1830).
10. Bowden CL, Grunze H, Mullen J et al. A randomized, double-blind, placebo-controlled efficacy and safety study of quetiapine or lithium as monotherapy for mania in bipolar disorder. J Clin Psychiatry 2005; 66: 111-121.
11. Kushner SF, Khan A, Lane R, Olson WH. Topiramate monotherapy in the management of acute mania: Results of four double-blind placebo-controlled trials. Bipolar Disord 2006; 8: 15-27.
12. Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry 1978; 133: 429-435.
13. Endicott J, Spitzer RL. A diagnostic interview: The schedule for affective disorders and schizophrenia. Arch Gen Psychiatry 1978; 35: 837-844.
14. American Psychiatric Association, 2002. Practice Guideline for the Treatment of Patients with Bipolar Disorder, revision. http://www.psych.org/psych_pract/treatg/pg/bipolar_revisebook_5.cfm#a (Accessed November 29, 2006).
15. Storosum JG, Fouwels A, Gispen-de Wied CC, Wohlfarth T, van Zwieten BJ, van den Brink W. How real are patients in placebo-controlled studies of acute manic episode? Eur Neuropsychopharmacol 2004; 14: 319-323.
16. Tohen M, Sanger TM, McElroy SL et al. Olanzapine versus placebo in the treatment of acute mania. Olanzapine HGEH Study Group. Am J Psychiatry 1999; 156: 702-709.
17. Tohen M, Jacobs TG, Grundy SL et.al. Efficacy of olanzapine in acute bipolar mania: A double-blind, placebo-controlled study. Olanzipine HGGW Study Group. Arch Gen Psychiatry 2000; 57: 841-849 (Erratum: Arch Gen Psychiatry 2002; 59: 91).
18. Keck PR Jr, Versiani M, Potkin S et al. Ziprasidone in the treatment of acute bipolar mania: A 3-week, placebo-controlled, double-blind, randomized trial. Am J Psychiatry 2003; 160: 741-748.
19. Potkin S, Keck PR Jr, Segal S, Ice K, English P. Ziprasidone in acute bipolar mania: A 21-day randomized, double-blind, placebo-controlled replication trial. J Clin Psychopharmacol 2005; 25: 301-310.
20. Keck PE Jr, Marcus R, Tourkodimitris S et al. A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania. Am J Psychiatry 2003; 160: 1651-1658.
21. Sachs G, Sanchez R, Marcus R et al. Aripiprazole in the treatment of acute manic or mixed episodes in patients with bipolar I disorder: A 3-week placebo-controlled study. J Psychopharmacol 2006; 20: 536-546.
22. Weisler RH, Kalali AH, Ketter TA, SPD417 Study Group. A multicenter, randomized, double-blind, placebo-controlled trial of extended-release carbamazepine capsules as monotherapy for bipolar disorder patients with manic or mixed episodes. J Clin Psychiatry 2004; 65: 478-484.
23. Smulevich AB, Khanna S, Eerdekens M, Karcher K, Kramer M, Grossman F. Acute and continuation risperidone monotherapy in bipolar mania: A 3-week placebo-controlled trial followed by a 9-week double-blind trial of risperidone and haloperidol. Eur Neuropsychopharmacol 2005; 15: 75-84.
24. Khanna S, Vieta E, Lyons B, Grossman F, Eerdekens M, Kramer M. Risperidone in the treatment of acute mania: Double-blind, placebo-controlled study. Br J Psychiatry 2005; 187: 229-234.
25. McIntyre RS, Brecher M, Paulsson B, Huizar K, Mullen J. Quetiapine or haloperidol as monotherapy for bipolar mania -a 12-week, double-blind, randomized, parallel-group, placebo-controlled trial. Eur Neuropsychopharmacol 2005; 15: 573-585.
26. Keck PE Jr, Welge JA, McElroy SL, Arnold LM, Strakowski SM. Placebo effect in randomized, controlled studies of acute bipolar mania and depression. Biol Psychiatry 2000; 47: 748-755.
27. Charney DS, Nemeroff CB, Lewis L et al. National Depressive and Manic-Depressive Association consensus statement on the use of placebo in clinical trials of mood disorders. Arch Gen Psychiatry 2002; 59: 262-270.