Official Title: “Are CT's Effects Durable?”

This study will evaluate the longer term effectiveness of cognitive therapy (CT) versus medication treatment or placebo for prevention of recurrence of depression for 24 months after termination of continuation phase therapy.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2010

Depression is a serious medical illness that is often difficult to diagnose and treat. It often recurs more than once in a person's lifetime. Effective treatment methods are needed to prevent the relapse in people who have had prior episodes of depression. CT is a short-term talking therapy that focuses on changing negative thinking patterns and helping patients develop coping skills to deal with their experiences. Evidence suggests that CT is effective in treating a number of psychiatric conditions, including anxiety and anger. This study will determine the effectiveness of booster sessions of CT versus antidepressant medication in preventing relapse of depression in people at risk for recurrent depression.

All participants in this double blind study will first receive 16 to 20 sessions of cognitive-behavioral therapy over 12 weeks. Participants who respond to the treatment, but do not achieve full remission of depressive symptoms, will be considered to be at risk for relapse. They will be randomly assigned to receive 10 booster sessions of one of three treatments over 8 months: cognitive-behavioral therapy, fluoxetine, or placebo. The booster sessions will take place twice monthly for the first 2 months and once monthly for the next 6 months. All participants who complete the entire 8 months of the study will be followed-up for an additional 2 years to monitor depressive relapse and psychosocial functioning.

Intervention(s) in this Clinical Trial

• Drug: Fluoxetine (Prozac)
  • Fluoxetine 10 to 40 mg/day for 8 months
• Behavioral: Cognitive therapy (CT)
  • Participants will attend CT sessions every-other week for 8 weeks, then monthly for 6 months.
• Drug: Placebo
  • Placebo daily for 8 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Participants will receive treatment with cognitive therapy during the continuation phase
• Experimental: 2
  • Participants will receive treatment with active fluoxetine during the continuation phase
• Placebo Comparator: 3
  • Patients participants will receive placebo in the continuation phase

Primary Measures

• Depressive relapse
  • Time Frame: Measured at Month 24
    Safety Issue?: No

Secondary Measures

• Psychosocial functioning
  • Time Frame: Measured at Month 24
    Safety Issue?: No

Inclusion Criteria:

• Diagnosis of recurrent unipolar major depressive disorder
• At least 2 episodes of major depression within lifetime, including present episode
• Speaks and reads English
• Seeking cognitive therapy treatment
• At least one period of complete inter-episode recovery or a history of dysthymia prior to the onset of the presenting or past episodes

Exclusion Criteria:

• Active alcohol or other substance dependence within the 6 months prior to study entry
• Active suicidal ideation with possible intent or probable risk
• Mood disorder due to a medical condition or substance use, bipolar disorder, schizophrenia, or schizoaffective disorder
• Unable to stop mood altering medications
• Concurrent medication or exclusionary medical disorders (diabetes, head injury, stroke, cancer, multiple sclerosis) that may cause depression
• Unable to attend clinic during business hours (Monday-Thursday, 8am-5pm) twice weekly
• Unable to complete questionnaires
• Unsuccessful treatment after 8 weeks of cognitive therapy with a certified therapist
• Unsuccessful treatment after 6 weeks of 40 mg of fluoxetine (Prozac)
• Pregnant or plans to become pregnant in the next 11-12 months

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Michael E. Thase, MD Principal Investigator University of PIttsburgh School of Medicine - Western Psychiatric Institute and Clinic  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00218764

Study ID Number: R01 MH69618

ClinicalTrials.gov Identifier: NCT00218764

Health Authority: United States: Federal Government