Depression Clinical Trial
Official title:
Prophylactic Cognitive Therapy for Depression
This study will compare the effectiveness of cognitive therapy versus antidepressant medication in treating depression and preventing relapse in individuals with recurrent depression.
Status | Terminated |
Enrollment | 523 |
Est. completion date | June 2011 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Recurrent unipolar major depressive disorder - At least two episodes of major depression - At least one period of recovery during a depressive episode or a history of dysthymia (a mood disorder characterized by depression) prior to the onset of current or past depressive episodes - 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 - Current 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 a medication that might cause depression - 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 6 weeks of 40 mg of Prozac - Pregnant or planning to become pregnant in the next 11-12 months - Unable to attend clinic twice weekly during business hours |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center/Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
National Institute of Mental Health (NIMH) |
United States,
Thase ME, Friedman ES, Berman SR, Fasiczka AL, Lis JA, Howland RH, Simons AD. Is cognitive behavior therapy just a 'nonspecific' intervention for depression? A retrospective comparison of consecutive cohorts treated with cognitive behavior therapy or supportive counseling and pill placebo. J Affect Disord. 2000 Jan-Mar;57(1-3):63-71. — View Citation
Thase ME, Friedman ES, Fasiczka AL, Berman SR, Frank E, Nofzinger EA, Reynolds CF 3rd. Treatment of men with major depression: a comparison of sequential cohorts treated with either cognitive-behavioral therapy or newer generation antidepressants. J Clin Psychiatry. 2000 Jul;61(7):466-72. — View Citation
Thase ME, Friedman ES. Is psychotherapy an effective treatment for melancholia and other severe depressive states? J Affect Disord. 1999 Jul;54(1-2):1-19. Review. — View Citation
Thase ME. How should efficacy be evaluated in randomized clinical trials of treatments for depression? J Clin Psychiatry. 1999;60 Suppl 4:23-31; discussion 32. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Depressive relapse | Measured at Month 9 | No | |
Secondary | Psychosocial functioning | Measured at Month 9 | No |
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