Prevention of Recurrence in Depression With Drugs and CT (CPT3)

Vanderbilt University

Status and phase: Completed; Phase 4

Conditions: Depression

Treatments: Behavioral: Cognitive Therapy; Drug: Medications

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00057577

R01MH060713 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 452 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

452 participants in 2 patient groups

Cognitive therapy plus medications

Experimental group

Description:

Participants will receive antidepressant medication plus cognitive therapy

Treatment:

Drug: Medications

Behavioral: Cognitive Therapy

Medications alone

Experimental group

Description:

Participants will receive maintenance of antidepressant medication alone

Treatment:

Drug: Medications