Official Title: “Prophylactic Cognitive Therapy for Depression”

This study will compare the effectiveness of cognitive therapy versus antidepressant medication in treating depression and preventing relapse in individuals with recurrent depression.

Study Type: Interventional

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

Study Primary Completion Date: December 2011

Cognitive therapy (CT) is a form of therapy that focuses on changing negative thinking patterns and developing coping skills to deal with psychological problems. It encourages individuals to think, feel, and behave in a more positive manner. Previous research has shown that CT is effective for treating a number of psychological symptoms, including anxiety, anger, and loneliness. Many studies show that CT is, in fact, more effective than antidepressant medications for treating various psychological disorders. The "self-help" mentality and coping skills that are developed during CT tend to decrease the likelihood of depression relapse. While antidepressants often cause many unpleasant side effects such as dizziness, nausea, and increased heart rate, there are no known negative side effects associated with CT. The purpose of this study is to evaluate the effectiveness of CT versus antidepressant medication for treating depression and preventing relapse in individuals with recurrent depression.

This 36-month study will consist of three phases. During Months 1 through 3, participants will receive between 16 and 20 CT sessions. Participants will then be randomly assigned to receive additional CT sessions, antidepressant medication, or placebo for 8 months. Upon completing treatment, follow-up visits will occur once every 4 months for a total of 24 months. Outcome measurements will include standardized psychological tests and questionnaires to assess the participant's level of depression. All measurements will be assessed at Week 1, Week 12, and Months 8, 12, 16, 20, and 24.

Intervention(s) in this Clinical Trial

• Drug: Fluoxetine
  • Fluoxetine 10 to 40 mg/day for 8 months
• Behavioral: Cognitive therapy (CT)
  • All participants will receive 16 to 20 individual sessions of CT for 3 months. Participants assigned to continuation phase will receive additional sessions every other week for 8 weeks and 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 continuation phase cognitive therapy for a total of 11 months of treatment
• Active Comparator: 2
  • Participants will receive 3 months of cognitive therapy and then 8 months of treatment with the antidepressant fluoxetine hydrochloride
• Placebo Comparator: 3
  • Participants will receive 3 months of cognitive therapy and then 8 months of treatment with placebo capsules

Primary Measures

• Depressive relapse
  • Time Frame: Measured at Month 9
    Safety Issue?: No

Secondary Measures

• Psychosocial functioning
  • Time Frame: Measured at Month 9
    Safety Issue?: No

Inclusion Criteria:

• Recurrent unipolar major depressive disorder
• At least two episodes of major depression
• At least one period of recovery during a depressive episode or a history of dysthymia (a mood disorder characterized by depression) prior to the onset of current or past depressive episodes
• Able to speak and read English

Exclusion Criteria:

• Active alcohol or other substance dependence within 6 months prior to study entry
• Currently at risk for suicide
• Current mood disorders due to a medical condition or substance abuse
• Bipolar, schizoaffective, obsessive compulsive, or eating disorders
• Schizophrenia
• Unable to stop mood-altering medications
• Current use of a medication that might cause depression
• Diagnosis of a medical disorder that may cause depression (e.g., diabetes, head injury, stroke, cancer, multiple sclerosis)
• Previous failure to experience a reduction in depressive symptoms after 6 weeks of 40 mg of Prozac
• Pregnant or planning to become pregnant in the next 11-12 months
• Unable to attend clinic twice weekly during business hours

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 The University of Pittsburgh School of Medicine  

Overall Contact: Marna S. Barnett, PhD 215-746-6680 msb@mail.med.upenn.edu

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00183664

Study ID Number: R01 MH58356

ClinicalTrials.gov Identifier: NCT00183664

Health Authority: United States: Federal Government