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

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

ChemIDplus related topics:

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 2012
Estimated Primary Completion Date:	December 2011 (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

Contacts


Contact: Marna S. Barrett, PhD	215-746-6680	msb@mail.med.upenn.edu

Contact: Teresa Hinton	215-746-6680	hintont@mail.med.upenn.edu

Locations


United States, Pennsylvania
	University of Pennsylvania School of Medicine	Recruiting
	Philadelphia, Pennsylvania, United States, 19104
	Contact: Marna S. Barrett, PhD 215-746-6680 msb@mail.med.upenn.edu
	Principal Investigator: Michael E. Thase, MD

United States, Texas
	The University of Texas Southwestern Medical Center at Dallas	Recruiting
	Dallas, Texas, United States, 75390.
	Contact: Amy McSpadden 214-648-5351 Amy.McSpadden@UTSouthwestern.edu

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
First Received:	September 21, 2005
Last Updated:	February 12, 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

Mood Disorders

Depressive Disorder, Major

Depressive Disorder

Serotonin

Recurrence

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Serotonin Uptake Inhibitors

Pharmacologic Actions

Behavioral Symptoms

Serotonin Agents

Mental Disorders

Therapeutic Uses

Antidepressive Agents, Second-Generation

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on July 03, 2008

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