Phase 4
Completed N=452
Prevention of Recurrence in Depression With Drugs and CT
Source: ClinicalTrials.gov NCT00057577 ↗Enrolled (actual)
452
Serious AEs
31.2%
Results posted
Apr 2015
Primary outcomePrimary: 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
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.
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 | — |
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
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. Informational only — not medical advice.