Prevention of Recurrence in Depression With Drugs and CT
Overview
- Phase
- Phase 4
- Intervention
- Cognitive Therapy
- Conditions
- Depression
- Sponsor
- Vanderbilt University
- Enrollment
- 452
- Locations
- 3
- Primary Endpoint
- Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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.
Detailed Description
It is commonly believed that the combination of ADM and psychotherapy is more effective in treating depression than either treatment alone. Data indicate that CT enhances the initial effects of ADM, but little research has been conducted to determine whether prior exposure to CT prevents the onset of new depressive episodes. This study will determine the effectiveness of adding CT to ADM for the treatment of depression. Participants are randomly assigned to receive either ADM alone or ADM plus CT for 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. At recovery, patients receiving combined treatment discontinue cognitive therapy; 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.
Investigators
Steven Hollon
Professor of Psychology
Vanderbilt University
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
Arms & Interventions
Cognitive therapy plus medications
Participants will receive antidepressant medication plus cognitive therapy
Intervention: Cognitive Therapy
Cognitive therapy plus medications
Participants will receive antidepressant medication plus cognitive therapy
Intervention: Medications
Medications alone
Participants will receive maintenance of antidepressant medication alone
Intervention: Medications
Outcomes
Primary Outcomes
Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD)
Time Frame: Through month 18 of treatment
Remission defined as four consecutive weeks of LIFE Problem Symptom Rating (PSR) values of 2 or less and HRSD scores of 8 or less for four consecutive weeks (with partial remission defined as LIFE PSR values of 3 or less and HRSD scores of 12 or less after month 12 only)
Number of Participants in Recovery According to the LIFE and HRSD
Time Frame: Through 36 months of treatment
Six consecutive months following remission without relapse (two weeks of elevated LIFE PSR scores of 4 or more and HRSD scores of 14 and above)
Number of Participants in Recurrence According to the LIFE and HRSD
Time Frame: Measured up to Month 36 from recovery
Recurrence defined as two consecutive weeks of elevated LIFE PSR scores of 5 or above and HRSD scores of 16 or above (three weeks during period of medication withdrawal)