Cognitive Therapy for Recurrent Depression
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
Recruitment status was Active, not recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00118404
First received: July 6, 2005
Last updated: October 17, 2008
Last verified: October 2008
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Prophylactic Cognitive Therapy for Depression. |
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 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 |
|---|---|
|
Experimental: 1
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.
|
|
Placebo Comparator: 2
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.
|
|
Active Comparator: 3
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.
Other Name: Prozac
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
Investigators
| Principal Investigator: | Robin B. Jarrett, PhD | University of Texas Southwestern Medical Center at Dallas |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Robin B. Jarrett, PhD, Professor of Psychiatry, The University of Texas Southwestern Medical Center at Dallas |
| ClinicalTrials.gov Identifier: | NCT00118404 History of Changes |
| Other Study ID Numbers: | R01 MH58397, R01 MH69619, DSIR 83-ATP |
| Study First Received: | July 6, 2005 |
| Last Updated: | October 17, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Cognitive therapy Antidepressants Psychotherapy Counseling |
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 16, 2013