Cognitive Therapy Versus Medication Treatment for Preventing Depression Relapse

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00218764
• Date of registration: 21/09/2005
• Prospective Registration: No
• Primary sponsor: National Institute of Mental Health (NIMH)
• Public title: Cognitive Therapy Versus Medication Treatment for Preventing Depression Relapse
• Scientific title: Are CT's Effects Durable?
• Date of first enrolment: December 2003
• Target sample size: 500
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00218764
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Michael E. Thase, MD
• Affiliation: University of PIttsburgh School of Medicine - Western Psychiatric Institute and Clinic

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Depression

Intervention(s)

Drug: Placebo

Behavioral: Cognitive therapy (CT)

Drug: Fluoxetine (Prozac)

Primary Outcome(s)

Depressive relapse [Time Frame: Measured at Month 24]

Secondary Outcome(s)

Psychosocial functioning [Time Frame: Measured at Month 24]

Secondary ID(s)

DSIR 83-ATSO

R01 MH69618

Source(s) of Monetary Support

Please refer to primary and secondary sponsors