Official Title: “Prophylactic Cognitive Therapy for Depression.”

This study will determine the effectiveness of continuation phase cognitive therapy versus antidepressant medication in preventing relapse of depression in people with recurrent depression.

Study Type: Interventional

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

Study Primary Completion Date: May 2012

Cognitive therapy (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 cognitive therapy versus antidepressant medication or placebo in preventing relapse of depression in people with recurrent depression.

This study will last approximately 36 months and will comprise three phases. For the first 12 weeks, all participants will receive between 16 and 20 CT sessions. Participants will then be randomly assigned to receive additional CT sessions, antidepressants, or placebo for an additional 8 months. Upon completing treatment, participants will have follow-up study visits once every 4 months for the next 24 months. Clinician-rated scales and questionnaires will be used to assess depressive symptoms of participants at study start and at the end of each study phase.

Intervention(s) in this Clinical Trial

• Behavioral: Continuation phase cognitive therapy
  • Continuation phase cognitive therapy includes 10 sessions over 8 months.
• Drug: Continuation phase fluoxetine
  • The dosage of fluoxetine will be increased to 40 mg over 8 months.
• Other: Continuation phase pill placebo
  • The dosage of pill placebo will be increased to 40 mg over 8 months.
• Behavioral: Initial phase cognitive therapy
  • For the first 12 weeks, all participants will receive between 16 and 20 cognitive therapy sessions.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Participants will receive initial phase and continuation phase cognitive therapy
• Placebo Comparator: 2
  • Participants will receive initial phase cognitive therapy and continuation phase pill placebo
• Active Comparator: 3
  • Participants will receive initial phase cognitive therapy and continuation phase fluoxetine

Primary Measures

• Depressive relapse
  • Time Frame: Measured at Month 8
    Safety Issue?: Yes

Secondary Measures

• Psychosocial functioning
  • Time Frame: Measured at Month 8
    Safety Issue?: No

Inclusion Criteria:

• Recurrent unipolar major depressive disorder
• Have experienced at least two episodes of major depression
• Have experienced at least one period of recovery during a depressive episode or have a history of dysthymia (a mood disorder characterized by depression) prior to the onset of current or past depressive episodes
• Willing and able to comply with all study requirements
• 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
• 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 medication or 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 8 weeks of cognitive therapy with a certified therapist
• Previous failure to experience a reduction in depressive symptoms after 6 weeks of 40 mg of Prozac
• Pregnancy or plan to become pregnant in the next 11-12 months
• Unable to attend clinic twice weekly during business hours
• Unable to complete questionnaires

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

Robin B. Jarrett, PhD Principal Investigator University of Texas Southwestern Medical Center at Dallas  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00118404

Study ID Number: R01 MH58397

ClinicalTrials.gov Identifier: NCT00118404

Health Authority: United States: Federal Government

Psychosocial Research and Depression Clinic