drugset / Trial / NCT00012558

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

NCT00012558 ↗

RandomizedDouble-blindTreatment

Summary

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

Timeline

Start
1998-09
Primary completion
—
Completion
2005-09

Outcome

Mixed primary results

paper The primary outcome was the percentage of subjects in each treatment group meeting the criterion for a durable recovery (8 consecutive weeks of euthymia). PMID 17392295 ↗

paper as did 51 of the 187 subjects (27.3%) receiving a mood stabilizer plus a matching placebo (P=0.40). PMID 17392295 ↗

paper The use of adjunctive, standard antidepressant medication, as compared with the use of mood stabilizers, was not associated with increased efficacy PMID 17392295 ↗

paper Primary outcomes included time to recovery and the proportion of patients classified as well during each of 12 study months. PMID 17404119 ↗

paper Patients receiving intensive psychotherapy had significantly higher year-end recovery rates (64.4% vs 51.5%) PMID 17404119 ↗

paper shorter times to recovery than patients in collaborative care (hazard ratio, 1.47; 95% confidence interval, 1.08-2.00; P = .01). PMID 17404119 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupropion Small molecule — —
Subject Inositol Other / unclassified — —
Subject Lamotrigine Small molecule — —
Subject Lithium Unknown — —
Subject Paroxetine Small molecule — —
Subject Risperidone Other / unclassified — —
Subject Tranylcypromine Small molecule — —
Subject Valproate Small molecule — —

Indications