Prevention of Recurrence in Depression With Drugs and CT
- Conditions
- Depression
- Interventions
- Behavioral: Cognitive TherapyDrug: Medications
- Registration Number
- NCT00057577
- Lead Sponsor
- Vanderbilt University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 452
- Recurrent or chronic major depressive disorder
- Current diagnosis of psychotic affective disorder
- History of nonaffective psychotic disorder
- Substance dependence last three months requiring detox
- Schizotypal, antisocial, or borderline personality disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive therapy plus medications Cognitive Therapy Participants will receive antidepressant medication plus cognitive therapy Cognitive therapy plus medications Medications Participants will receive antidepressant medication plus cognitive therapy Medications alone Medications Participants will receive maintenance of antidepressant medication alone
- Primary Outcome Measures
Name Time Method Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD) 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 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 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Depression Research Unit, University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt Adult Outpatient Psychiatry
🇺🇸Nashville, Tennessee, United States
Rush Medical Center - Treatment Research Unit
🇺🇸Chicago, Illinois, United States