Cognitive Therapy Versus Medication Treatment for Preventing Depression Relapse - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00218764

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

MedlinePlus related topics: Depression

Drug Information available for: Fluoxetine Fluoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Are CT's Effects Durable?

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Depressive relapse [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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
1: Experimental 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.
2: Experimental Participants will receive treatment with active fluoxetine during the continuation phase	Drug: Fluoxetine (Prozac) Fluoxetine 10 to 40 mg/day for 8 months
3: Placebo Comparator 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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218764

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.

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Michael E. Thase, MD

University of PIttsburgh School of Medicine - Western Psychiatric Institute and Clinic

More Information

Responsible Party:	University of Pennsylvania School of Medicine ( Michael E. Thase, MD )
Study ID Numbers:	R01 MH69618, DSIR 83-ATSO
Study First Received:	September 21, 2005
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00218764
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

MDDRU
Major Depressive Disorder Recurrent Unipolar

Study placed in the following topic categories:

Fluoxetine
Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major

Depressive Disorder
Serotonin
Recurrence
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Serotonin Uptake Inhibitors
Antidepressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009