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Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00012558
First Posted: March 15, 2001
Last Update Posted: May 4, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Mental Health (NIMH)
No Study Results Posted on ClinicalTrials.gov for this Study
  Study Status: This study has been completed.
  Estimated Study Completion Date: September 2005
  Primary Completion Date: No date given
Publications:
Lembke A, Miklowitz DJ, Otto MW, Zhang H, Wisniewski SR, Sachs GS, Thase ME, Ketter TA; STEP-BD Investigators. Psychosocial service utilization by patients with bipolar disorders: data from the first 500 participants in the Systematic Treatment Enhancement Program. J Psychiatr Pract. 2004 Mar;10(2):81-7.
Perlis RH, Miyahara S, Marangell LB, Wisniewski SR, Ostacher M, DelBello MP, Bowden CL, Sachs GS, Nierenberg AA; STEP-BD Investigators. Long-term implications of early onset in bipolar disorder: data from the first 1000 participants in the systematic treatment enhancement program for bipolar disorder (STEP-BD). Biol Psychiatry. 2004 May 1;55(9):875-81.
Simon NM, Otto MW, Weiss RD, Bauer MS, Miyahara S, Wisniewski SR, Thase ME, Kogan J, Frank E, Nierenberg AA, Calabrese JR, Sachs GS, Pollack MH; STEP-BD Investigators. Pharmacotherapy for bipolar disorder and comorbid conditions: baseline data from STEP-BD. J Clin Psychopharmacol. 2004 Oct;24(5):512-20.
Marangell LB, Martinez JM, Ketter TA, Bowden CL, Goldberg JF, Calabrese JR, Miyahara S, Miklowitz DJ, Sachs GS, Thase ME; STEP-BD Investigators. Lamotrigine treatment of bipolar disorder: data from the first 500 patients in STEP-BD. Bipolar Disord. 2004 Apr;6(2):139-43.
Schneck CD, Miklowitz DJ, Calabrese JR, Allen MH, Thomas MR, Wisniewski SR, Miyahara S, Shelton MD, Ketter TA, Goldberg JF, Bowden CL, Sachs GS. Phenomenology of rapid-cycling bipolar disorder: data from the first 500 participants in the Systematic Treatment Enhancement Program. Am J Psychiatry. 2004 Oct;161(10):1902-8.
Kogan JN, Otto MW, Bauer MS, Dennehy EB, Miklowitz DJ, Zhang HW, Ketter T, Rudorfer MV, Wisniewski SR, Thase ME, Calabrese J, Sachs GS; STEP-BD Investigators. Demographic and diagnostic characteristics of the first 1000 patients enrolled in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). Bipolar Disord. 2004 Dec;6(6):460-9.
Simon NM, Otto MW, Wisniewski SR, Fossey M, Sagduyu K, Frank E, Sachs GS, Nierenberg AA, Thase ME, Pollack MH. Anxiety disorder comorbidity in bipolar disorder patients: data from the first 500 participants in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). Am J Psychiatry. 2004 Dec;161(12):2222-9.
Morris CD, Miklowitz DJ, Wisniewski SR, Giese AA, Thomas MR, Allen MH. Care satisfaction, hope, and life functioning among adults with bipolar disorder: data from the first 1000 participants in the Systematic Treatment Enhancement Program. Compr Psychiatry. 2005 Mar-Apr;46(2):98-104.
Allen MH, Chessick CA. Instability of symptoms in recurrent major depression. Am J Psychiatry. 2005 Feb;162(2):403; author reply 403-4.
Nierenberg AA, Miyahara S, Spencer T, Wisniewski SR, Otto MW, Simon N, Pollack MH, Ostacher MJ, Yan L, Siegel R, Sachs GS; STEP-BD Investigators. Clinical and diagnostic implications of lifetime attention-deficit/hyperactivity disorder comorbidity in adults with bipolar disorder: data from the first 1000 STEP-BD participants. Biol Psychiatry. 2005 Jun 1;57(11):1467-73.
Weiss RD, Ostacher MJ, Otto MW, Calabrese JR, Fossey M, Wisniewski SR, Bowden CL, Nierenberg AA, Pollack MH, Salloum IM, Simon NM, Thase ME, Sachs GS; for STEP-BD Investigators. Does recovery from substance use disorder matter in patients with bipolar disorder? J Clin Psychiatry. 2005 Jun;66(6):730-5; quiz 808-9.
Fagiolini A, Kupfer DJ, Masalehdan A, Scott JA, Houck PR, Frank E. Functional impairment in the remission phase of bipolar disorder. Bipolar Disord. 2005 Jun;7(3):281-5.
Nierenberg AA, Ostacher MJ, Calabrese JR, Ketter TA, Marangell LB, Miklowitz DJ, Miyahara S, Bauer MS, Thase ME, Wisniewski SR, Sachs GS. Treatment-resistant bipolar depression: a STEP-BD equipoise randomized effectiveness trial of antidepressant augmentation with lamotrigine, inositol, or risperidone. Am J Psychiatry. 2006 Feb;163(2):210-6.
Perlis RH, Ostacher MJ, Patel JK, Marangell LB, Zhang H, Wisniewski SR, Ketter TA, Miklowitz DJ, Otto MW, Gyulai L, Reilly-Harrington NA, Nierenberg AA, Sachs GS, Thase ME. Predictors of recurrence in bipolar disorder: primary outcomes from the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). Am J Psychiatry. 2006 Feb;163(2):217-24.
Fossey MD, Otto MW, Yates WR, Wisniewski SR, Gyulai L, Allen MH, Miklowitz DJ, Coon KA, Ostacher MJ, Neel JL, Thase ME, Sachs GS, Weiss RD; Step-BD Investigators. Validity of the distinction between primary and secondary substance use disorder in patients with bipolar disorder: data from the first 1000 STEP-BD participants. Am J Addict. 2006 Mar-Apr;15(2):138-43.
Zhang H, Wisniewski SR, Bauer MS, Sachs GS, Thase ME; Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) Investigators. Comparisons of perceived quality of life across clinical states in bipolar disorder: data from the first 2000 Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) participants. Compr Psychiatry. 2006 May-Jun;47(3):161-8.
Joffe H, Kim DR, Foris JM, Baldassano CF, Gyulai L, Hwang CH, McLaughlin WL, Sachs GS, Thase ME, Harlow BL, Cohen LS. Menstrual dysfunction prior to onset of psychiatric illness is reported more commonly by women with bipolar disorder than by women with unipolar depression and healthy controls. J Clin Psychiatry. 2006 Feb;67(2):297-304.
Joffe H, Cohen LS, Suppes T, McLaughlin WL, Lavori P, Adams JM, Hwang CH, Hall JE, Sachs GS. Valproate is associated with new-onset oligoamenorrhea with hyperandrogenism in women with bipolar disorder. Biol Psychiatry. 2006 Jun 1;59(11):1078-86. Epub 2006 Jan 31.
Sachs GS, Yan LJ, Swann AC, Allen MH. Integration of suicide prevention into outpatient management of bipolar disorder. J Clin Psychiatry. 2001;62 Suppl 25:3-11. Review.
Waxmonsky JA, Thomas MR, Miklowitz DJ, Allen MH, Wisniewski SR, Zhang H, Ostacher MJ, Fossey MD. Prevalence and correlates of tobacco use in bipolar disorder: data from the first 2000 participants in the Systematic Treatment Enhancement Program. Gen Hosp Psychiatry. 2005 Sep-Oct;27(5):321-8.
Martinez JM, Marangell LB, Simon NM, Miyahara S, Wisniewski SR, Harrington J, Pollack MH, Sachs GS, Thase ME. Baseline predictors of serious adverse events at one year among patients with bipolar disorder in STEP-BD. Psychiatr Serv. 2005 Dec;56(12):1541-8.
Goldberg JF, Allen MH, Miklowitz DA, Bowden CL, Endick CJ, Chessick CA, Wisniewski SR, Miyahara S, Sagduyu K, Thase ME, Calabrese JR, Sachs GS. Suicidal ideation and pharmacotherapy among STEP-BD patients. Psychiatr Serv. 2005 Dec;56(12):1534-40.
Allen MH, Chessick CA, Miklowitz DJ, Goldberg JF, Wisniewski SR, Miyahara S, Calabrese JR, Marangell L, Bauer MS, Thomas MR, Bowden CL, Sachs GS. Contributors to suicidal ideation among bipolar patients with and without a history of suicide attempts. Suicide Life Threat Behav. 2005 Dec;35(6):671-80.
Bauer MS, Wisniewski SR, Marangell LB, Chessick CA, Allen MH, Dennehy EB, Miklowitz DJ, Thase ME, Sachs GS. Are antidepressants associated with new-onset suicidality in bipolar disorder? A prospective study of participants in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). J Clin Psychiatry. 2006 Jan;67(1):48-55.
Miklowitz DJ, Wisniewski SR, Miyahara S, Otto MW, Sachs GS. Perceived criticism from family members as a predictor of the one-year course of bipolar disorder. Psychiatry Res. 2005 Sep 15;136(2-3):101-11.
Perlis RH, Delbello MP, Miyahara S, Wisniewski SR, Sachs GS, Nierenberg AA; STEP-BD investigators. Revisiting depressive-prone bipolar disorder: polarity of initial mood episode and disease course among bipolar I systematic treatment enhancement program for bipolar disorder participants. Biol Psychiatry. 2005 Oct 1;58(7):549-53. Epub 2005 Sep 28.
Baldassano CF, Marangell LB, Gyulai L, Ghaemi SN, Joffe H, Kim DR, Sagduyu K, Truman CJ, Wisniewski SR, Sachs GS, Cohen LS. Gender differences in bipolar disorder: retrospective data from the first 500 STEP-BD participants. Bipolar Disord. 2005 Oct;7(5):465-70.
Mansour HA, Talkowski ME, Wood J, Pless L, Bamne M, Chowdari KV, Allen M, Bowden CL, Calabrese J, El-Mallakh RS, Fagiolini A, Faraone SV, Fossey MD, Friedman ES, Gyulai L, Hauser P, Ketter TA, Loftis JM, Marangell LB, Miklowitz DJ, Nierenberg AA, Patel J, Sachs GS, Sklar P, Smoller JW, Thase ME, Frank E, Kupfer DJ, Nimgaonkar VL. Serotonin gene polymorphisms and bipolar I disorder: focus on the serotonin transporter. Ann Med. 2005;37(8):590-602. Review.
Ghaemi SN, Hsu DJ, Thase ME, Wisniewski SR, Nierenberg AA, Miyahara S, Sachs G. Pharmacological Treatment Patterns at Study Entry for the First 500 STEP-BD Participants. Psychiatr Serv. 2006 May;57(5):660-5.
Miklowitz DJ, Otto MW, Wisniewski SR, Araga M, Frank E, Reilly-Harrington NA, Lembke A, Sachs GS. Psychotherapy, symptom outcomes, and role functioning over one year among patients with bipolar disorder. Psychiatr Serv. 2006 Jul;57(7):959-65.
Otto MW, Simon NM, Wisniewski SR, Miklowitz DJ, Kogan JN, Reilly-Harrington NA, Frank E, Nierenberg AA, Marangell LB, Sagduyu K, Weiss RD, Miyahara S, Thas ME, Sachs GS, Pollack MH; STEP-BD Investigators. Prospective 12-month course of bipolar disorder in out-patients with and without comorbid anxiety disorders. Br J Psychiatry. 2006 Jul;189:20-5.
Friedman E, Gyulai L, Bhargava M, Landen M, Wisniewski S, Foris J, Ostacher M, Medina R, Thase M. Seasonal changes in clinical status in bipolar disorder: a prospective study in 1000 STEP-BD patients. Acta Psychiatr Scand. 2006 Jun;113(6):510-7.
Wolff N, Perlick DA, Kaczynski R, Calabrese J, Nierenberg A, Miklowitz DJ. Modeling costs and burden of informal caregiving for persons with bipolar disorder. J Ment Health Policy Econ. 2006 Jun;9(2):99-110.
Marangell LB, Suppes T, Ketter TA, Dennehy EB, Zboyan H, Kertz B, Nierenberg A, Calabrese J, Wisniewski SR, Sachs G. Omega-3 fatty acids in bipolar disorder: clinical and research considerations. Prostaglandins Leukot Essent Fatty Acids. 2006 Oct-Nov;75(4-5):315-21. Epub 2006 Aug 22.
Marangell LB, Bauer MS, Dennehy EB, Wisniewski SR, Allen MH, Miklowitz DJ, Oquendo MA, Frank E, Perlis RH, Martinez JM, Fagiolini A, Otto MW, Chessick CA, Zboyan HA, Miyahara S, Sachs G, Thase ME. Prospective predictors of suicide and suicide attempts in 1,556 patients with bipolar disorders followed for up to 2 years. Bipolar Disord. 2006 Oct;8(5 Pt 2):566-75.
Miklowitz DJ, Otto MW. New psychosocial interventions for bipolar disorder: A review of the literature and introduction of the systematic treatment enhancement program. Journal of Cognitive Psychotherapy 2006; 20(2): 215-230.
Sachs GS, Nierenberg AA, Calabrese JR, Marangell LB, Wisniewski SR, Gyulai L, Friedman ES, Bowden CL, Fossey MD, Ostacher MJ, Ketter TA, Patel J, Hauser P, Rapport D, Martinez JM, Allen MH, Miklowitz DJ, Otto MW, Dennehy EB, Thase ME. Effectiveness of adjunctive antidepressant treatment for bipolar depression. N Engl J Med. 2007 Apr 26;356(17):1711-22. Epub 2007 Mar 28.
Miklowitz DJ, Otto MW, Frank E, Reilly-Harrington NA, Wisniewski SR, Kogan JN, Nierenberg AA, Calabrese JR, Marangell LB, Gyulai L, Araga M, Gonzalez JM, Shirley ER, Thase ME, Sachs GS. Psychosocial treatments for bipolar depression: a 1-year randomized trial from the Systematic Treatment Enhancement Program. Arch Gen Psychiatry. 2007 Apr;64(4):419-26.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Mizushima J, Uchida H, Tada M, Suzuki T, Mimura M, Nio S. Early Improvement of Specific Symptoms Predicts Subsequent Recovery in Bipolar Depression: Reanalysis of the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) Data. J Clin Psychiatry. 2017 Feb;78(2):e146-e151. doi: 10.4088/JCP.15m10573.
Tada M, Uchida H, Mizushima J, Suzuki T, Mimura M, Nio S. Antidepressant dose and treatment response in bipolar depression: Reanalysis of the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) data. J Psychiatr Res. 2015 Sep;68:151-6. doi: 10.1016/j.jpsychires.2015.06.015. Epub 2015 Jun 23.
Prisciandaro JJ, Tolliver BK. Evidence for the continuous latent structure of mania and depression in out-patients with bipolar disorder: results from the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). Psychol Med. 2015;45(12):2595-603. doi: 10.1017/S0033291715000513. Epub 2015 Apr 17.
Stange JP, Sylvia LG, da Silva Magalhães PV, Miklowitz DJ, Otto MW, Frank E, Berk M, Nierenberg AA, Deckersbach T. Extreme attributions predict the course of bipolar depression: results from the STEP-BD randomized controlled trial of psychosocial treatment. J Clin Psychiatry. 2013 Mar;74(3):249-55. doi: 10.4088/JCP.12m08019.
Magalhães PV, Kapczinski F, Nierenberg AA, Deckersbach T, Weisinger D, Dodd S, Berk M. Illness burden and medical comorbidity in the Systematic Treatment Enhancement Program for Bipolar Disorder. Acta Psychiatr Scand. 2012 Apr;125(4):303-8. doi: 10.1111/j.1600-0447.2011.01794.x. Epub 2011 Nov 19.
Ghaemi SN, Ostacher MM, El-Mallakh RS, Borrelli D, Baldassano CF, Kelley ME, Filkowski MM, Hennen J, Sachs GS, Goodwin FK, Baldessarini RJ. Antidepressant discontinuation in bipolar depression: a Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) randomized clinical trial of long-term effectiveness and safety. J Clin Psychiatry. 2010 Apr;71(4):372-80. doi: 10.4088/JCP.08m04909gre.
Goldberg JF, Brooks JO 3rd, Kurita K, Hoblyn JC, Ghaemi SN, Perlis RH, Miklowitz DJ, Ketter TA, Sachs GS, Thase ME. Depressive illness burden associated with complex polypharmacy in patients with bipolar disorder: findings from the STEP-BD. J Clin Psychiatry. 2009 Feb;70(2):155-62. Epub 2009 Feb 10.
Nowakowska C, Sachs GS, Zarate CA Jr, Marangell LB, Calabrese JR, Goldberg JF, Ketter TA. Increased rate of non-right-handedness in patients with bipolar disorder. J Clin Psychiatry. 2008 May;69(5):866-7.
Marangell LB, Dennehy EB, Wisniewski SR, Bauer MS, Miyahara S, Allen MH, Martinez M, Al Jurdi RK, Thase ME. Case-control analyses of the impact of pharmacotherapy on prospectively observed suicide attempts and completed suicides in bipolar disorder: findings from STEP-BD. J Clin Psychiatry. 2008 Jun;69(6):916-22.
Miklowitz DJ, Otto MW, Frank E, Reilly-Harrington NA, Kogan JN, Sachs GS, Thase ME, Calabrese JR, Marangell LB, Ostacher MJ, Patel J, Thomas MR, Araga M, Gonzalez JM, Wisniewski SR. Intensive psychosocial intervention enhances functioning in patients with bipolar depression: results from a 9-month randomized controlled trial. Am J Psychiatry. 2007 Sep;164(9):1340-7.


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