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Bipolar DisorderNCT00012558

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

A study testing lithium, valproate and bupropion in people with Bipolar Disorder, run by National Institute of Mental Health (NIMH) at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 15 years and older
Conditions the study is for
Bipolar Disorder
What is being tested?
lithium, valproate and bupropion
How many people
5,000 participants
Where
11 sitesUnited States
Study dates
Sep 1998to Sep 2005
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • University of Colorado, Colorado Psychiatric Health Clinical Investigation Center

    Denver, Colorado, 80220

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104-2649

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Portland Veteran's Administration Medical Center

    Portland, Oregon, 97201

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • Stanford University School of Medicine

    Stanford, California, 94305-5723

  • University of Oklahoma Health Sciences Center

    Tulsa, Oklahoma, 74135

  • University of Massachusetts Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

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

Read the 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.

Being tested
lithium, valproate, bupropion, paroxetine, lamotrigine
Keywords
Psychotic Disorders, Mood Disorders, Manic-Depressive Illness, Hypomania, Mania, Mood Stabilizer
Medical subject headings
Bipolar Disorder, Psychotic Disorders, Mood Disorders, Major Affective Disorder 2, Mania

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lithiumDrug

  • valproateDrug

  • bupropionDrug

  • paroxetineDrug

  • lamotrigineDrug

  • risperidoneDrug

  • inositolDrug

  • tranylcypromineDrug

  • Cognitive Behavioral TherapyBehavioural

  • Family-focused TherapyBehavioural

  • Interpersonal and Social Rhythms TherapyBehavioural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2001 (estimated)
  2. Study startSep 1998
  3. Study completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Masking
Double blind
Enrolment
5,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00012558
Sponsor's protocol ID
N01MH80001
Other IDs
DSIR AT
Status last verified
Apr 2007
First submitted
13 Mar 2001
Last updated
4 May 2007
Results posted
No

Publications

  • 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.

    PubMed 12788248

  • 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.

    PubMed 12479665

  • 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.

    PubMed 15330934

  • 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.

    PubMed 12778844

  • 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.

  • 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.

  • 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.

    PubMed 15330403

  • 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.

    PubMed 15110730

  • 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.

    PubMed 15349007

  • 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.

    PubMed 15005752

  • 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.

    PubMed 15465989

  • 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.

    PubMed 15541061

  • 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.

    PubMed 15569893

  • 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.

    PubMed 15723025

  • 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.

    PubMed 15677618

Questions about this trial

What is this clinical trial studying?

A study testing lithium, valproate and bupropion in people with Bipolar Disorder, run by National Institute of Mental Health (NIMH) at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00012558, which also lists 60 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2007; AzTrials last refreshed its copy on 29 Oct 2026.

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