Cognitive Therapy Versus Medication Treatment for Preventing Depression Relapse
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Depression |
Drug: Fluoxetine (Prozac) Behavioral: Cognitive therapy (CT) Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Are CT's Effects Durable? |
- Depressive relapse [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
- Psychosocial functioning [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | December 2003 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive treatment with cognitive therapy during the continuation phase
|
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
|
|
Experimental: 2
Participants will receive treatment with active fluoxetine during the continuation phase
|
Drug: Fluoxetine (Prozac)
Fluoxetine 10 to 40 mg/day for 8 months
Other Name: Prozac
|
|
Placebo Comparator: 3
Patients participants will receive placebo in the continuation phase
|
Drug: Placebo
Placebo daily for 8 months
|
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | 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
Contacts and Locations| United States, Pennsylvania | |
| University of Pennsylvania School of Medicine | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| The University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75390. | |
| Principal Investigator: | Michael E. Thase, MD | University of PIttsburgh School of Medicine - Western Psychiatric Institute and Clinic |
More Information
No publications provided by National Institute of Mental Health (NIMH)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Michael E. Thase, MD, University of Pennsylvania School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00218764 History of Changes |
| Other Study ID Numbers: | R01 MH69618, DSIR 83-ATSO |
| Study First Received: | September 21, 2005 |
| Last Updated: | October 21, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
MDDRU Major Depressive Disorder Recurrent Unipolar |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Fluoxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013