Cognitive Therapy for Recurrent Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robin Jarrett, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00118404
First received: July 6, 2005
Last updated: June 4, 2013
Last verified: June 2013

July 6, 2005
June 4, 2013
December 1999
July 2008   (final data collection date for primary outcome measure)
Depressive relapse [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: Yes ]
Depressive relapse
Complete list of historical versions of study NCT00118404 on ClinicalTrials.gov Archive Site
Psychosocial functioning [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]
Psychosocial functioning
Not Provided
Not Provided
 
Cognitive Therapy for Recurrent Depression
Prophylactic Cognitive Therapy for Depression.

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • Behavioral: Continuation phase cognitive therapy
    Continuation phase cognitive therapy includes 10 sessions over 8 months.
  • Drug: Continuation phase fluoxetine
    The dosage of fluoxetine will be increased to 40 mg over 8 months.
    Other Name: Prozac
  • 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.
  • Experimental: 1
    Participants will receive initial phase and continuation phase cognitive therapy
    Interventions:
    • Behavioral: Continuation phase cognitive therapy
    • Behavioral: Initial phase cognitive therapy
  • Placebo Comparator: 2
    Participants will receive initial phase cognitive therapy and continuation phase pill placebo
    Interventions:
    • Other: Continuation phase pill placebo
    • Behavioral: Initial phase cognitive therapy
  • Active Comparator: 3
    Participants will receive initial phase cognitive therapy and continuation phase fluoxetine
    Interventions:
    • Drug: Continuation phase fluoxetine
    • Behavioral: Initial phase cognitive therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
523
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00118404
R01 MH58397, R01MH058397, R01 MH69619, DSIR 83-ATP
Yes
Robin Jarrett, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
National Institute of Mental Health (NIMH)
Principal Investigator: Robin B. Jarrett, PhD University of Texas Southwestern Medical Center at Dallas
University of Texas Southwestern Medical Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP