CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 523 enrolled
Drug / intervention
Continuation phase fluoxetine +3 moredrug
Likely dose
Fluoxetine 40 mg daily over 8 months (continuation phase)AI-extracted
Key inclusion· 5
  • ✓Recurrent unipolar major depressive disorder
  • ✓At least two episodes of major depression
  • ✓History of recovery between episodes or prior dysthymia
  • ✓Able to speak and read English
Key exclusion· 11
  • ✕Active alcohol or substance dependence within 6 months
  • ✕Current suicidal risk
  • ✕Bipolar, schizoaffective, OCD, eating disorders, or schizophrenia
  • ✕Schizophrenia

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

Search/NCT00118404
NCT00118404Phase 3Completed
CompareCT.gov

Prophylactic Cognitive Therapy for Depression.

University of Texas Southwestern Medical Center·interventional·Posted Jul 11, 2005·Updated Jun 5, 2014

In Brief

A Phase 3 clinical trial evaluating Continuation phase cognitive therapy, Continuation phase fluoxetine, and 2 other interventions for Depression. Completed, enrolled 523 participants across 2 sites.

Detailed Summary

This study determined the effectiveness of continuation phase cognitive therapy versus antidepressant medication in preventing relapse of depression in people with recurrent depression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 11, 2005
Enrollment StartMar 1, 2000
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 21.0 years ago

Interventions

Continuation phase cognitive therapybehavioral

Continuation phase cognitive therapy included 10 sessions over 8 months.

Continuation phase fluoxetinedrug

The dosage of fluoxetine was increased to 40 mg over 8 months.

Continuation phase pill placeboother

The dosage of pill placebo was increased to 40 mg over 8 months.

Acute phase cognitive therapybehavioral

For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.