Clinical trial NCT00012558: Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)
Official title: Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Psychotic Disorders
Mood Disorders
Manic-Depressive Illness
Hypomania
Mania
Mood Stabilizer
Lead sponsor: National Institute of Mental Health (NIMH)
Sponsor class: NIH
First posted: 2001-03-15
Enrollment: 5000
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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

Detailed description: STEP-BD is evaluating all the best-practice treatment options used for bipolar disorder: mood-stabilizing medications, antidepressants, atypical antipsychotics, and psychosocial interventions - or "talk" therapies - including Cognitive Behavioral Therapy, Family-focused Therapy, Interpersonal and Social Rhythm Therapy, and Collaborative Care (psychoeducation).

There are two kinds of treatment "pathways" in STEP-BD, and participants may have the opportunity to take part in both. The medications and psychosocial interventions provided in these pathways are considered among the best choices of treatment for bipolar disorder in everyday clinical practice.

In the "Best Practice Pathway," participants are followed by a STEP-BD certified doctor and all treatment choices are individualized. Everyone enrolled in STEP-BD may participate in this pathway. Participants and their doctors work together to decide on the best treatment plans and to change these plans if needed. Also, anyone who wishes to stay on his or her current treatment upon entering STEP-BD may do so in this pathway. Adolescents and adults age 15 years and older may participate in the Best Practice Pathway.

For adults age 18 and older, another way to participate is in the STEP-BD "Randomized Care Pathways." Depending on their symptoms, participants may be offered treatment in one or more of these pathways during the course of the study. The participants remain on mood-stabilizing medication. However, because doctors are uncertain which of several treatment strategies work best for bipolar disorder, another medication and/or talk therapy may be added. Each Randomized Care Pathway involves a different set of these additional treatments.

Unlike in the Best Practice Pathway, the participants in the Randomized Care Pathways are randomly assigned to treatments. Also, in some cases, neither the participant nor the doctor will be told which of the different medications is being added. This is called a "double-blind" study and is done so that the medication effects can be evaluated objectively, without any unintended bias that may come from knowing what has been assigned. Participants will not be assigned medications that they have had bad reactions to in the past, that they are strongly opposed to, or that the doctor feels are unsuitable for them. The medication(s) participants may be randomly assigned to in the Randomized Care Pathways are free of charge. There are other treatment options for participants if they do not respond well to the treatment assigned to them. Also, participants may return to the Best Practice Pathway at any time. About 1,500 individuals will be enrolled in at least one Randomized Care Pathway during their period of participation in STEP-BD.

It is important to note that STEP-BD provides continuity of care. For example, if a participant starts out in the Best Practice Pathway and later chooses to enter one of the Randomized Care Pathways, he or she continues with the same STEP-BD doctor and treatment team. Then, after completing the Randomized Care Pathway, the participant may return to the Best Practice Pathway for ongoing, individually-tailored treatment.

Eligibility criteria: General Inclusion Criteria:

* 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.

General Exclusion Criteria:

* 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Denver
country: United States
facility: University of Colorado, Colorado Psychiatric Health Clinical Investigation Center
state: Colorado
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical Center
state: Massachusetts
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Tulsa
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Portland
country: United States
facility: Portland Veteran's Administration Medical Center
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Massachusetts General Hospital
name: Gary Sachs, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Michael Thase, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.