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

NCT00012558 | Completed

• 2 other identifiers: N01MH80001DSIR AT
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 11

Brief Summary

A long-term study of current treatments for bipolar disorder, including medications and psychosocial therapies.

Conditions

Bipolar Disorder

Keywords

Psychotic Disorders; Mood Disorders; Manic-Depressive Illness; Hypomania; Mania; Mood Stabilizer

Interventions

lithium DRUG

valproate DRUG

bupropion DRUG

paroxetine DRUG

lamotrigine DRUG

risperidone DRUG

inositol DRUG

tranylcypromine DRUG

Cognitive Behavioral Therapy BEHAVIORAL

Family-focused Therapy BEHAVIORAL

Interpersonal and Social Rhythms Therapy BEHAVIORAL

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• current age 15 or older (Best Practice Pathway) or 18 years or older (Randomized Care Pathways);
• able to give informed consent for data to be harvested;
• meet DSM-IV criteria for Bipolar I Disorder, Bipolar II Disorder, Bipolar Disorder NOS, or Cyclothymic Disorder;
• undergo a complete standard evaluation including clinical interview, self ratings, and laboratory studies;
• meet with Clinical Specialist as scheduled;
• able to complete all Study Registry Forms within 3 months of registration.

You may not qualify if:

• unwilling or unable to adhere to basic study requirements (i.e., complete rating forms, or attend scheduled evaluations);
• not competent to give informed consent in the opinion of the investigator (e.g., psychotic).
• Participants will be asked to remain in the study for up to five years so that the investigators can document and evaluate long-term treatment outcome. Participants will meet with their STEP-BD psychiatrist for periodic evaluations and/or treatment adjustments during the course of the study, fill out various self-rating forms, and when applicable, participate in psychotherapy. One of the psychotherapy options, Family-Focused Therapy, will require participants and their families to attend counseling sessions together. Overall, the estimated amount of time required from participants in the study is 2 to 4 hours per month.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (11)

Stanford University School of Medicine

Stanford, California, 94305-5723, United States

Location

University of Colorado, Colorado Psychiatric Health Clinical Investigation Center

Denver, Colorado, 80220, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Massachusetts Medical Center

Worcester, Massachusetts, 01655, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

University of Oklahoma Health Sciences Center

Tulsa, Oklahoma, 74135, United States

Location

Portland Veteran's Administration Medical Center

Portland, Oregon, 97201, United States

Location

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104-2649, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Related Publications (59)

• Sachs GS, Thase ME, Otto MW, Bauer M, Miklowitz D, Wisniewski SR, Lavori P, Lebowitz B, Rudorfer M, Frank E, Nierenberg AA, Fava M, Bowden C, Ketter T, Marangell L, Calabrese J, Kupfer D, Rosenbaum JF. Rationale, design, and methods of the systematic treatment enhancement program for bipolar disorder (STEP-BD). Biol Psychiatry. 2003 Jun 1;53(11):1028-42. doi: 10.1016/s0006-3223(03)00165-3.

  PMID: 12788248 BACKGROUND

• Sachs GS, Guille C, McMurrich SL. A clinical monitoring form for mood disorders. Bipolar Disord. 2002 Oct;4(5):323-7. doi: 10.1034/j.1399-5618.2002.01195.x.

  PMID: 12479665 BACKGROUND

• Sachs GS. Strategies for improving treatment of bipolar disorder: integration of measurement and management. Acta Psychiatr Scand Suppl. 2004;(422):7-17. doi: 10.1111/j.1600-0447.2004.00409.x.

  PMID: 15330934 BACKGROUND

• Thase ME, Bhargava M, Sachs GS. Treatment of bipolar depression: current status, continued challenges, and the STEP-BD approach. Psychiatr Clin North Am. 2003 Jun;26(2):495-518. doi: 10.1016/s0193-953x(03)00029-7.

  PMID: 12778844 BACKGROUND

• Perlick DA, Wolff N, Miklowitz DJ, Menard K, Rosenheck RR, & STEP-BD Family Experience Collaborative Study Group [abstract]. Development of an Integrated Model of Family Burden in Bipolar Illness. The Journal of Mental Health Policy and Economics 6(Supplemental): 37, 2003.

  BACKGROUND

• Gray SM, Frankle WG, Sachs GS. STEP BD: A design for evaluating effectiveness of treatment for bipolar disorder. The Economics of Neuroscience 3(1): 65-68, 2001.

  BACKGROUND

• 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. doi: 10.1097/00131746-200403000-00002.

  PMID: 15330403 RESULT

• 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. doi: 10.1016/j.biopsych.2004.01.022.

  PMID: 15110730 RESULT

• 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. doi: 10.1097/01.jcp.0000138772.40515.70.

  PMID: 15349007 RESULT

• 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. doi: 10.1111/j.1399-5618.2004.00098.x.

  PMID: 15005752 RESULT

• 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. doi: 10.1176/ajp.161.10.1902.

  PMID: 15465989 RESULT

• 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. doi: 10.1111/j.1399-5618.2004.00158.x.

  PMID: 15541061 RESULT

• 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. doi: 10.1176/appi.ajp.161.12.2222.

  PMID: 15569893 RESULT

• 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. doi: 10.1016/j.comppsych.2004.07.026.

  PMID: 15723025 RESULT

• Allen MH, Chessick CA. Instability of symptoms in recurrent major depression. Am J Psychiatry. 2005 Feb;162(2):403; author reply 403-4. doi: 10.1176/appi.ajp.162.2.403. No abstract available.

  PMID: 15677618 RESULT

• 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. doi: 10.1016/j.biopsych.2005.01.036.

  PMID: 15950022 RESULT

• 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. doi: 10.4088/jcp.v66n0609.

  PMID: 15960566 RESULT

• 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. doi: 10.1111/j.1399-5618.2005.00207.x.

  PMID: 15898966 RESULT

• 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. doi: 10.1176/appi.ajp.163.2.210.

  PMID: 16449473 RESULT

• 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. doi: 10.1176/appi.ajp.163.2.217.

  PMID: 16449474 RESULT

• 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. doi: 10.1080/10550490500528423.

  PMID: 16595351 RESULT

• 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. doi: 10.1016/j.comppsych.2005.08.001.

  PMID: 16635643 RESULT

• 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. doi: 10.4088/jcp.v67n0218.

  PMID: 16566627 RESULT

• 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. doi: 10.1016/j.biopsych.2005.10.017. Epub 2006 Jan 31.

  PMID: 16448626 RESULT

• 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.

  PMID: 11765093 RESULT

• 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. doi: 10.1016/j.genhosppsych.2005.05.003.

  PMID: 16168792 RESULT

• 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. doi: 10.1176/appi.ps.56.12.1541.

  PMID: 16339616 RESULT

• 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. doi: 10.1176/appi.ps.56.12.1534.

  PMID: 16339615 RESULT

• 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. doi: 10.1521/suli.2005.35.6.671.

  PMID: 16552982 RESULT

• 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. doi: 10.4088/jcp.v67n0108.

  PMID: 16426088 RESULT

• 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. doi: 10.1016/j.psychres.2005.04.005.

  PMID: 16023735 RESULT

• 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. doi: 10.1016/j.biopsych.2005.07.029. Epub 2005 Sep 28.

  PMID: 16197928 RESULT

• 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. doi: 10.1111/j.1399-5618.2005.00237.x.

  PMID: 16176440 RESULT

• 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. doi: 10.1080/07853890500357428.

  PMID: 16338761 RESULT

• 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. doi: 10.1176/ps.2006.57.5.660.

  PMID: 16675760 RESULT

• 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. doi: 10.1176/ps.2006.57.7.959.

  PMID: 16816280 RESULT

• 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. doi: 10.1192/bjp.bp.104.007773.

  PMID: 16816301 RESULT

• 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. doi: 10.1111/j.1600-0447.2005.00701.x.

  PMID: 16677228 RESULT

• 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.

  PMID: 17007487 RESULT

• 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. doi: 10.1016/j.plefa.2006.07.008. Epub 2006 Aug 22.

  PMID: 16928441 RESULT

• 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. doi: 10.1111/j.1399-5618.2006.00369.x.

  PMID: 17042830 RESULT

• Miklowitz DJ, Otto MW. Psychosocial interventions for bipolar disorder: a review of literature and introduction of the systematic treatment enhancement program. Psychopharmacol Bull. 2007;40(4):116-31.

  PMID: 18227782 RESULT

• 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. doi: 10.1056/NEJMoa064135. Epub 2007 Mar 28.

  PMID: 17392295 RESULT

• 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. doi: 10.1001/archpsyc.64.4.419.

  PMID: 17404119 RESULT

• Prisciandaro JJ, Tolliver BK, DeSantis SM. Identification and initial validation of empirically derived bipolar symptom states from a large longitudinal dataset: an application of hidden Markov modeling to the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) study. Psychol Med. 2019 May;49(7):1102-1108. doi: 10.1017/S0033291718002143. Epub 2018 Aug 29.

  PMID: 30153871 DERIVED

• Bareis N, Lu J, Kirkwood CK, Kornstein SG, Wu E, Mezuk B. Identifying clinical net benefit of psychotropic medication use with latent variable techniques: Evidence from Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). J Affect Disord. 2018 Oct 1;238:147-155. doi: 10.1016/j.jad.2018.05.063. Epub 2018 May 29.

  PMID: 29883936 DERIVED

• Slyepchenko A, Frey BN, Lafer B, Nierenberg AA, Sachs GS, Dias RS. Increased illness burden in women with comorbid bipolar and premenstrual dysphoric disorder: data from 1 099 women from STEP-BD study. Acta Psychiatr Scand. 2017 Nov;136(5):473-482. doi: 10.1111/acps.12797. Epub 2017 Aug 28.

  PMID: 28846801 DERIVED

• 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.

  PMID: 28234437 DERIVED

• Prisciandaro JJ, Tolliver BK. An item response theory evaluation of the young mania rating scale and the montgomery-asberg depression rating scale in the systematic treatment enhancement program for bipolar disorder (STEP-BD). J Affect Disord. 2016 Nov 15;205:73-80. doi: 10.1016/j.jad.2016.06.062. Epub 2016 Jul 13.

  PMID: 27420134 DERIVED

• Ballard ED, Vande Voort JL, Luckenbaugh DA, Machado-Vieira R, Tohen M, Zarate CA. Acute risk factors for suicide attempts and death: prospective findings from the STEP-BD study. Bipolar Disord. 2016 Jun;18(4):363-72. doi: 10.1111/bdi.12397. Epub 2016 May 27.

  PMID: 27233466 DERIVED

• 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.

  PMID: 26228414 DERIVED

• 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.

  PMID: 25881582 DERIVED

• Stange JP, Sylvia LG, da Silva Magalhaes 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.

  PMID: 23561230 DERIVED

• Magalhaes 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.

  PMID: 22098628 DERIVED

• 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.

  PMID: 20409444 DERIVED

• 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. doi: 10.4088/jcp.08m04301. Epub 2009 Feb 10.

  PMID: 19210946 DERIVED

• 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. doi: 10.4088/jcp.v69n0522g. No abstract available.

  PMID: 18681768 DERIVED

• 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. doi: 10.4088/jcp.v69n0605.

  PMID: 18399724 DERIVED

• 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. doi: 10.1176/appi.ajp.2007.07020311.

  PMID: 17728418 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Psychotic Disorders; Mood Disorders; Major Affective Disorder 2; Mania

Interventions

Lithium; Valproic Acid; Bupropion; Paroxetine; Lamotrigine; Risperidone; Inositol; Tranylcypromine; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Propiophenones; Ketones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Triazines; Pyrimidinones; Pyrimidines; Sugar Alcohols; Alcohols; Carbohydrates; Propylamines; Amines; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gary Sachs, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Michael Thase, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 13, 2001
• First Posted: March 15, 2001
• Study Start: September 1, 1998
• Study Completion: September 1, 2005
• Last Updated: May 4, 2007

Record last verified: 2007-04

Locations

US (11)