Cognitive Therapy Versus Medication Treatment for Preventing Depression Relapse
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: Fluoxetine (Prozac) (Drug); Cognitive therapy (CT) (Behavioral); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: National Institute of Mental Health (NIMH) Official(s) and/or principal investigator(s):
Michael E. Thase, MD, Principal Investigator, Affiliation: University of PIttsburgh School of Medicine - Western Psychiatric Institute and Clinic
Overall contact:
Marna S. Barrett, PhD, Phone: 215-746-6680, Email: msb@mail.med.upenn.edu
Summary
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.
Clinical Details
Official title: Are CT's Effects Durable?
Study design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Depressive relapse
Secondary outcome: Psychosocial functioning
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Marna S. Barrett, PhD, Phone: 215-746-6680, Email: msb@mail.med.upenn.edu
University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104, United States; Recruiting
Marna S. Barrett, PhD, Phone: 215-746-6680, Email: msb@mail.med.upenn.edu
Michael E. Thase, MD, Principal Investigator
The University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75390., United States; Recruiting
Amy McSpadden, Phone: 214-648-5351, Email: Amy.McSpadden@UTSouthwestern.edu
Additional Information
Starting date: December 2003
Ending date: December 2012
Last updated: February 12, 2008
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