Cognitive Therapy for Recurrent Depression - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00118404

Purpose

This study will determine the effectiveness of continuation phase cognitive therapy versus antidepressant medication in preventing relapse of depression in people with recurrent depression.

Condition	Intervention	Phase
Depression	Behavioral: Continuation phase cognitive therapy Drug: Continuation phase fluoxetine Other: Continuation phase pill placebo Behavioral: Initial phase cognitive therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Prophylactic Cognitive Therapy for Depression.

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Fluoxetine Fluoxetine hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

Depressive relapse [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Psychosocial functioning [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]

Enrollment:	523
Study Start Date:	December 1999
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive initial phase and continuation phase cognitive therapy	Behavioral: Continuation phase cognitive therapy Continuation phase cognitive therapy includes 10 sessions over 8 months. Behavioral: Initial phase cognitive therapy For the first 12 weeks, all participants will receive between 16 and 20 cognitive therapy sessions.
2: Placebo Comparator Participants will receive initial phase cognitive therapy and continuation phase pill placebo	Other: Continuation phase pill placebo The dosage of pill placebo will be increased to 40 mg over 8 months. Behavioral: Initial phase cognitive therapy For the first 12 weeks, all participants will receive between 16 and 20 cognitive therapy sessions.
3: Active Comparator Participants will receive initial phase cognitive therapy and continuation phase fluoxetine	Drug: Continuation phase fluoxetine The dosage of fluoxetine will be increased to 40 mg over 8 months. Behavioral: Initial phase cognitive therapy For the first 12 weeks, all participants will receive between 16 and 20 cognitive therapy sessions.

Detailed Description:

Cognitive therapy (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 cognitive therapy versus antidepressant medication or placebo in preventing relapse of depression in people with recurrent depression.

This study will last approximately 36 months and will comprise three phases. For the first 12 weeks, all participants will receive between 16 and 20 CT sessions. Participants will then be randomly assigned to receive additional CT sessions, antidepressants, or placebo for an additional 8 months. Upon completing treatment, participants will have follow-up study visits once every 4 months for the next 24 months. Clinician-rated scales and questionnaires will be used to assess depressive symptoms of participants at study start and at the end of each study phase.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Recurrent unipolar major depressive disorder
Have experienced at least two episodes of major depression
Have experienced at least one period of recovery during a depressive episode or have a history of dysthymia (a mood disorder characterized by depression) prior to the onset of current or past depressive episodes
Willing and able to comply with all study requirements
Able to speak and read English

Exclusion Criteria:

Active alcohol or other substance dependence within 6 months prior to study entry
Currently at risk for suicide
Mood disorders due to a medical condition or substance abuse
Bipolar, schizoaffective, obsessive compulsive, or eating disorders
Schizophrenia
Unable to stop mood-altering medications
Current use of medication or diagnosis of a medical disorder that may cause depression (e.g., diabetes, head injury, stroke, cancer, multiple sclerosis)
Previous failure to experience a reduction in depressive symptoms after 8 weeks of cognitive therapy with a certified therapist
Previous failure to experience a reduction in depressive symptoms after 6 weeks of 40 mg of Prozac
Pregnancy or plan to become pregnant in the next 11-12 months
Unable to attend clinic twice weekly during business hours
Unable to complete questionnaires

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118404

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
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:

Robin B. Jarrett, PhD

University of Texas Southwestern Medical Center at Dallas

More Information

Additional Information:

Psychosocial Research and Depression Clinic This link exits the ClinicalTrials.gov site

Publications:

Hollon SD, Jarrett RB, Nierenberg AA, Thase ME, Trivedi M, Rush AJ. Psychotherapy and medication in the treatment of adult and geriatric depression: which monotherapy or combined treatment? J Clin Psychiatry. 2005 Apr;66(4):455-68. Review.

Jarrett RB, Kraft D, Doyle J, Foster BM, Eaves GG, Silver PC. Preventing recurrent depression using cognitive therapy with and without a continuation phase: a randomized clinical trial. Arch Gen Psychiatry. 2001 Apr;58(4):381-8.

Jarrett RB, Schaffer M, McIntire D, Witt-Browder A, Kraft D, Risser RC. Treatment of atypical depression with cognitive therapy or phenelzine Arch Gen Psychiatry. 2000 Nov;57(11):1084. No abstract available.

Responsible Party:	The University of Texas Southwestern Medical Center at Dallas ( Robin B. Jarrett, PhD, Professor of Psychiatry )
Study ID Numbers:	R01 MH58397, R01 MH69619, DSIR 83-ATP
Study First Received:	July 6, 2005
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00118404 History of Changes
Health Authority:	United States: Federal Government

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

Cognitive therapy
Antidepressants
Psychotherapy
Counseling

Study placed in the following topic categories:

Neurotransmitter Agents
Depression
Psychotropic Drugs
Depressive Disorder
Serotonin Uptake Inhibitors
Recurrence
Serotonin

Behavioral Symptoms
Fluoxetine
Mental Disorders
Mood Disorders
Antidepressive Agents, Second-Generation
Antidepressive Agents

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions

Behavioral Symptoms
Fluoxetine
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 09, 2009