Cognitive Therapy Versus Medication Treatment for Preventing Depression Relapse

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by National Institute of Mental Health (NIMH).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00218764
First received: September 21, 2005
Last updated: October 21, 2008
Last verified: October 2008
  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?

Resource links provided by NLM:


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
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
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
Mental Disorders
Mood Disorders
Fluoxetine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014