CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 382 target
Drug / intervention
Bipolar Disorder Program +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00007761
NCT00007761Phase 3Completed

CSP #430 - Reducing The Efficacy-Effectiveness Gap In Bipolar Disorder

US Department of Veterans Affairs·interventional·Posted Jan 1, 2001·Updated Sep 24, 2009

In Brief

A Phase 3 clinical trial evaluating Bipolar Disorder Program and Usual (psychiatric) Care for Bipolar Disorder. Completed, enrolled 382 participants across 13 sites.

Detailed Summary

Based on highly promising preliminary data, it is proposed to conduct a multi-site randomized controlled trial of a high-intensity ambulatory treatment program for bipolar disorder against standard office-based, physician-centered care. The major characteristics of this program are that it emphasizes (1) aggressive guideline-driven pharmacotherapy, (2) continuity of care with identified primary mental health nurse clinicians supported by psychiatrist back-up, and (3) patient education to improve treatment alliance and illness management skills.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 1, 2001
Enrollment StartJul 1, 1997
Primary CompletionDec 1, 2003
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 25.5 years ago

Interventions

Bipolar Disorder Programbehavioral

Usual (psychiatric) Carebehavioral