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Cognitive Therapy Versus Medication Treatment for Preventing Depression Relapse

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by National Institute of Mental Health (NIMH).
Recruitment status was:  Active, not recruiting
Information provided by:
National Institute of Mental Health (NIMH) Identifier:
First received: September 21, 2005
Last updated: October 21, 2008
Last verified: October 2008

September 21, 2005
October 21, 2008
December 2003
December 2010   (Final data collection date for primary outcome measure)
Depressive relapse [ Time Frame: Measured at Month 24 ]
Depressive relapse; measured at Month 11
Complete list of historical versions of study NCT00218764 on Archive Site
Psychosocial functioning [ Time Frame: Measured at Month 24 ]
Psychosocial functioning; measured at Month 11
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Cognitive Therapy Versus Medication Treatment for Preventing Depression Relapse
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.

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.

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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
  • Drug: Fluoxetine (Prozac)
    Fluoxetine 10 to 40 mg/day for 8 months
    Other Name: Prozac
  • Behavioral: Cognitive therapy (CT)
    Participants will attend CT sessions every-other week for 8 weeks, then monthly for 6 months.
    Other Name: CT or CBT
  • Drug: Placebo
    Placebo daily for 8 months
  • Experimental: 1
    Participants will receive treatment with cognitive therapy during the continuation phase
    Intervention: Behavioral: Cognitive therapy (CT)
  • Experimental: 2
    Participants will receive treatment with active fluoxetine during the continuation phase
    Intervention: Drug: Fluoxetine (Prozac)
  • Placebo Comparator: 3
    Patients participants will receive placebo in the continuation phase
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
December 2010
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Michael E. Thase, MD, University of Pennsylvania School of Medicine
National Institute of Mental Health (NIMH)
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Principal Investigator: Michael E. Thase, MD University of PIttsburgh School of Medicine - Western Psychiatric Institute and Clinic
National Institute of Mental Health (NIMH)
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP