CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 452 enrolled
Drug / intervention
Medications +1 moredrug
Likely dose
Not stated in record
Key inclusion· 1
  • Recurrent or chronic major depressive disorder
Key exclusion· 4
  • Current diagnosis of psychotic affective disorder
  • History of nonaffective psychotic disorder
  • Substance dependence in the last three months requiring detoxification
  • Schizotypal, antisocial, or borderline personality disorder

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

Search/NCT00057577
NCT00057577Phase 4Completed

Prevention of Recurrence in Depression With Drugs and CT

Vanderbilt University·interventional·Posted Apr 7, 2003·Updated May 30, 2017

In Brief

A Phase 4 clinical trial evaluating Cognitive Therapy and Medications for Depression. Completed, enrolled 452 participants across 3 sites.

Detailed Summary

This study will determine whether the addition of Cognitive Therapy (CT) to antidepressant medication (ADM) enhances treatment for depression. This study will also test whether the addition of CT to ADM will prevent recurrences of depression after therapy is over.

Study Details

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

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 7, 2003
Enrollment StartOct 1, 2002
Primary CompletionJul 1, 2012
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9.8 yearsPosted 23.2 years ago

Interventions

Cognitive Therapybehavioral

CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.

Medicationsdrug

Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.