Comparison of mania patients suitable for treatment trials versus clinical treatment

Human Psychopharmacology

Volumn 23, Issue 6, 2008, Pages 447-454

  Talamo, Alessandra ^a,b,c   Baldessarini, Ross J ^a,b   Centorrino, Franca ^a,b  

^a HARVARD MEDICAL SCHOOL   (United States)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

^c MCLEAN HOSPITAL   (United States)

Author keywords

Bipolar disorder; Inclusion exclusion criteria; Mania; Randomized clinical trial

Indexed keywords

MOOD STABILIZER;

ADULT; ARTICLE; COMORBIDITY; COMPARATIVE STUDY; FEMALE; HOSPITAL PATIENT; HUMAN; MAJOR CLINICAL STUDY; MALE; MANIA; MENTAL PATIENT; PATIENT SELECTION; PILOT STUDY; PRIORITY JOURNAL; PSYCHIATRIC TREATMENT; RESEARCH SUBJECT; SUBSTANCE ABUSE; SUICIDE ATTEMPT; VIOLENCE;

BIPOLAR DISORDER; HUMANS; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 51049111989     PISSN: 08856222     EISSN: 10991077     Source Type: Journal    
DOI: 10.1002/hup.952     Document Type: Article

References (58)

1. Akobeng AK. 2005. Principles of evidence based medicine. Arch Dis Child 90: 837-840.
2. American Psychiatric Association. 2000. American Psychiatric Association Diagnostic and Statistical Manual for Mental Disorders DSM IV-TR, 4th edn (Text Revision). American Psychiatric Press: Washington DC.
3. Baldessarini RJ. 2002. Treatment research in bipolar disorder: issues and recommendations. CNS Drugs 16: 721-729.
4. Baldessarini RJ, Tarazi FI. 2005. Drugs and the treatment of psychiatric disorders. Chapters 17 and 18. In Goodman and Gilman's The Pharmacological Basis of Therapeutics, 11th edn, Brunton LL, Lazo JS, Parker KL (eds). McGraw-Hill: New York; 429-500.
5. Baldessarini RJ, Tohen M, Tondo L. 2000. Maintenance treatment in bipolar disorder. Arch Gen Psychiatry 57: 490-492.
6. Baldessarini RJ, Leahy LF, Arcona S, Gause D, Zhang W, Hennen J. 2007a. Prescribing patterns of psychotropic medicines in the United States for patients diagnosed with bipolar disorders. Psychiatr Serv 58: 85-91.
7. Baldessarini RJ, Henk HJ, Chang J, Leahy LF. 2007b. Use of psychotropics by 7567 American bipolar disorder patients (2001-2004), (Poster/ Abstract; NR373). Proceedings of the American Psychiatric Association (APA) Annual Meeting, May.
8. Bowden CL, Calabrese JR, Wallin BA, et al. 1995. Illness characteristics of patients in clinical drug studies of mania. Psychopharmacol Bull 31: 103-109.
9. Bowden CL, Swann AC, Calabrese JR, et al. 1997. Maintenance clinical trials in bipolar disorder: design implications of the divalproex-lithium-placebo study. Psychopharmacol Bull 33: 693-699.
10. Bowden CL, Calabrese JR, McElroy SL, et al. 2000. Randomized, placebo-controlled 12-month trial of divalproex and lithium in treatment of outpatients with bipolar I disorder. Arch Gen Psychiatry 57: 481-489.
11. Bowden CL, Grunze H, Mullen J, et al. 2005. Randomized, double-blind, placebo-controlled efficacy and safety study of quetiapine or lithium as monotherapy for mania in bipolar disorder. J Clin Psychiatry 66: 111-121.
12. Bowden CL, Swann AC, Calabrese JR, et al. 2006. A randomized, placebo-controlled, multicenter study of divalproex sodium extended release in the treatment of acute mania. J Clin Psychiatry 67: 1501-1510.
13. Braslow JT, Duan N, Starks SL, et al. 2005. Generalizability of studies on mental health treatment and outcomes, 1981-1996. Psychiatr Serv 56: 1261-1268.
14. Cassidy F, Ahearn EP, Carroll BJ. 2001. Substance abuse in bipolar disorder. Bipolar Disord 3: 181-188.
15. Centorrino F, Fogarty KV, Sani G, et al. 2005. Use of combinations of antipsychotics. Hum Psychopharmacol 20: 485-492.
16. Centorrino F, Sani G, Fogarty KV, et al. 2006. Combinations of mood-stabilizers with antipsychotics as treatment strategies in hospitalized psychiatric patients. Clin Neuropsychiatry J Treat Eval 3: 322-326.
17. Centorrino F, Cincotta SL, Talamo A, et al. 2008. Hospital use of antipsychozic drugs: polytherapy. Compr Psychiatry 49: 65-69.
18. Dans AL, Dans LF, Guyatt GH, Richardson S. 1998. Users' guides to the medical literature: how to decide on the applicability of clinical trial results to your patient. JAMA 279: 545-549.
19. Fagiolini A, Frank E, Scott JA, Turkin S, Kupfer DJ. 2005. Metabolic syndrome in bipolar disorder. Bipolar Disord 7: 424-430.
20. Ghaemi SN, Pope HG, Jr. 1994. Lack of insight in psychotic and affective disorders: review of empirical studies. Harv Rev Psychiatry 2: 22-33.
21. Guy W (ed.). 1970. ECDEU Assessment Manual for Psychopharmacology. Publication ADM 76-338. US Department of Health Education and Welfare: Rockville, MD.
22. Harvey PD. 2006. Defining and achieving recovery from bipolar disorder. J Clin Psychiatry 67 (Suppl 9): 14-42.
23. Hirschfeld RM, Allen MH, McEvoy JP, Keck PE, Jr., Russell JM. 1999. Safety and tolerability of oral loading divalproex sodium in acutely manic bipolar patients. J Clin Psychiatry 60: 815-818.
24. Hirschfeld RM, Keck PE, Jr., Kramer M, et al. 2004. Rapid antimanic effect of risperidone monotherapy: a 3-week multicenter, double-blind, placebo-controlled trial. Am J Psychiatry 161: 1057-1065.
25. Janicak PG, Sharma RP, Pandey G, Davis JM. 1998. Verapamil for the treatment of acute mania: double-blind, placebo-controlled trial. Am J Psychiatry 155: 972-973.
26. Keck PE, Jr., Marcus R, Tourkodimitris S, et al. 2003a. Placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania. Am J Psychiatry 160: 1651-1658.
27. Keck PE, Jr., Versiani M, Potkin S, West SA, Giller E, Ice K. 2003b. Ziprasidone in the treatment of acute bipolar mania: a three-week, placebo-controlled, double-blind, randomized trial. Am J Psychiatry 160: 741-748.
28. Khalsa HM, Salvatore P, Hennen J, Baethge C, Tohen M, Baldessarini RJ. 2008. Suicidal events and accidents in 216 first-episode bipolar I disorder patients: predictive factors. J Affect Disord 106: 179-184.
29. Khanna S, Vieta E, Lyons B, Grossman F, Eerdekens M, Kramer M. 2005. Risperidone in the treatment of acute mania: double-blind, placebo-controlled study. Br J Psychiatry 187: 229-234.
30. Kruger S, Braunig P, Hoffler J, Shugar G, Borner I, Langkrar J. 2000. Prevalence of obsessive-compulsive disorder in schizophrenia and significance of motor symptoms. J Neuropsychiatry Clin Neurosci 12: 16-24.
31. Licht RW. 2001. Limitations in randomized controlled trials evaluating drug effects in mania. Eur Arch Psychiatry Clin Neurosci 251 (Suppl 2): 66-71.
32. Licht RW. 2002. Limits of the applicability and generalizability of drug trials in mania. Bipolar Disord 4 (Suppl 1): 66-68.
33. Licht RW, Gouliaev G, Vestergaard P, Frydenberg M. 1997. Generalizability of results from randomized drug trials: a trial of antimanic treatment. Br J Psychiatry 170: 264-267.
34. MacKinnon DF, Zandi PP, Cooper J, et al. 2002. Comorbid bipolar disorder and panic disorder in families with a high prevalence of bipolar disorder. Am J Psychiatry 159: 30-35.
35. Montgomery SA, Åsberg M. 1979. A new depression scale designed to be sensitive to change. Br J Psychiatry 134: 382-389.
36. Olschewski M, Schumacher M, Davis KB. 1992. Analysis of randomized and nonrandomized patients in clinical trials using the comprehensive cohort follow-up study design. Control Clin Trials 13: 226-239.
37. Ösby U, Brandt L, Correia N, Ekbom A, Sparen P. 2001. Excess mortality in bipolar and unipolar disorder in Sweden. Arch Gen Psychiatry 58: 844-850.
38. Potkin SG, Keck PE, Jr., Segal S, Ice K, English P. 2005. Ziprasidone in acute bipolar mania: 21-day randomized, double-blind, placebo-controlled replication trial. J Clin Psychopharmacol 25: 301-310.
39. Regier DA, Farmer ME, Rae DS, et al. 1990. Comorbidity of mental disorders with alcohol and other drug abuse: results from the Epidemiologic Catchment Area (ECA) Study. JAMA 264: 2511-2518.
40. Revicki DA, Paramore LC, Sommerville KW, Swann AC, Zajecka JM, Depakote Comparator Study Group. 2003. Divalproex sodium versus olanzapine in the treatment of acute mania in bipolar disorder: health-related quality of life and medical cost outcomes. J Clin Psychiatry 64: 288-294.
41. Sachs GS, Grossman F, Ghaemi SN, Okamoto A, Bowden CL. 2002. Combination of a mood stabilizer with risperidone or haloperidol for treatment of acute mania: double-blind, placebo-controlled comparison of efficacy and safety. Am J Psychiatry 159: 1146-1154.
42. Simon NM, Otto MW, Weiss RD, et al. 2004. Pharmacotherapy for bipolar disorder and comorbid conditions: baseline data from STEP-BD. J Clin Psychopharmacol 24: 512-520.
43. Simon GE, Hunkeler E, Fireman B, Lee JY, Savarino J. 2007. Risk of suicide attempt and suicide death in patients treated for bipolar disorder. Bipolar Disord 9: 526-530.
44. Singh JB, Zarate CA, Jr. 2006. Pharmacological treatment of psychiatric co-morbidity in bipolar disorder: review of controlled trials. Bipolar Disord 8: 696-709.
45. Smulevich AB, Khanna S, Eerdekens M, Karcher K, Kramer M, Grossman F. 2005. 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 15: 75-84.
46. Stiegler M, Rummel C, Wahlbeck K, Kissling W, Leucht S. 2005. European psychiatric treatment guidelines: is the glass half full or half empty? Eur Psychiatry 20: 554-558.
47. Stoll AL, Severus WE, Freeman MP, et al. 1999. Omega 3 fatty acids in bipolar disorder: a preliminary double-blind, placebo-controlled trial. Arch Gen Psychiatry 56: 407-412.
48. Suppes T, Dennehy EB, Hirschfeld RM, et al. 2005. Texas implementation of medication algorithms: update to algorithms for treatment of bipolar I disorder. J Clin Psychiatry 66: 870-886.
49. Tohen M, Sanger TM, McElroy SL, et al. 1999. Olanzapine vs. placebo in the treatment of acute mania. Am J Psychiatry 156: 702-709.
50. Tohen M, Jacobs TG, Grundy SL, et al. 2000. Efficacy of olanzapine in acute bipolar mania: a double-blind, placebo-controlled study. Arch Gen Psychiatry 57: 841-849.
51. Vieta E, Carne X. 2005. The use of placebo in clinical trials on bipolar disorder: new approach for an old debate. Psychother Psychosom 74: 10-16.
52. Vieta E, Bourin M, Sanchez R, et al. 2005. Effectiveness of aripiprazole vs. haloperidol in acute bipolar mania: double-blind, randomized, comparative 12-week trial. Br J Psychiatry 187: 235-242.
53. Weisler RH, Kalali AH, Ketter TA. 2004. 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 65: 478-484.
54. Weisler RH, Keck PE, Jr., Swann AC, Cutler AJ, Ketter TA, Kalali AH. 2005. Extended-release carbamazepine capsules as monotherapy for acute mania in bipolar disorder: a multicenter, randomized, double-blind, placebo-controlled trial. J Clin Psychiatry 66: 323-330.
55. Yildiz-Yesiloglu A, Guleryuz S, Ankerst DP, Öngür D, Renshaw PF. 2008. Protein kinase C inhibition in the treatment of mania: double-blind, placebo-controlled trial of tamoxifen. Arch Gen Psychiatry 65: 255-263.
56. Young RC, Biggs JT, Ziegler VE, Meyer DA. 1978. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry 133: 429-435.
57. Zajecka JM, Weisler R, Sachs G, Swann AC, Wozniak P, Sommerville KW. 2002. A comparison of the efficacy, safety, and tolerability of divalproex sodium and olanzapine in the treatment of bipolar disorder. J Clin Psychiatry 63: 1148-1155.
58. Zarate CA, Jr., Singh JB, Carlson PJ, et al. 2007. Efficacy of a protein kinase C inhibitor (tamoxifen) in the treatment of acute mania: a pilot study. Bipolar Disord 9: 561-570.