Phase 4 N=452 Randomized Single-blind Prevention

Prevention of Recurrence in Depression With Drugs and CT

Depression

Bottom Line

View on ClinicalTrials.gov: NCT00057577 ↗

Enrolled (actual)

452

Serious AEs

31.2%

Results posted

Apr 2015

Primary outcome: Primary: Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD) — 187; 170 number participants that reach remission — p==.038

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Cognitive Therapy (Behavioral); Medications (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt University
Primary completion: Jul 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD)	187; 170	=.038 sig
PRIMARY Number of Participants in Recovery According to the LIFE and HRSD	165; 140	<0.01 sig
PRIMARY Number of Participants in Recurrence According to the LIFE and HRSD	78; 85; 79; 103	—

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.

Eligibility Criteria

Inclusion Criteria

Recurrent or chronic major depressive disorder

Exclusion Criteria

Current diagnosis of psychotic affective disorder
History of nonaffective psychotic disorder
Substance dependence last three months requiring detox
Schizotypal, antisocial, or borderline personality disorder

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00057577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.