Unipolar Depression Clinical Trial
Official title:
Maintenance Therapies in Late-Life Depression 2 (MTLD-2)
This study will evaluate the effectiveness of paroxetine versus interpersonal psychotherapy and a combination of the two in helping elderly patients with depression remain well and improve quality of their lives.
This is primarily a study of maintenance therapies, not a study of acute therapeutic
efficacy, in late-life major depression. The study aims to identify factors that encourage
maintenance of treatment gains and to identify which patients need which kinds of treatment
to remain well. The following questions are to be addressed:
- Is the probability of recurrence different among the treatment groups?
- What variables may be related to, or predictive of, differences among groups?
- After 1 to 2 years of maintenance therapy, will patients assigned to maintenance
combined treatment with both paroxetine and interpersonal psychotherapy remain well at
higher rates than patients assigned to paroxetine alone, interpersonal psychotherapy
alone, or placebo?
- Will the time to recurrence differ across treatment groups, and what variables may be
related to, or predictive of, time to recurrence?
The major study hypothesis is that combined treatment with paroxetine and interpersonal
psychotherapy will be superior to either treatment alone (and to placebo) in preventing
recurrence of major depressive episodes in patients aged 70 and above.
For information on related studies, please follow these links:
http://clinicaltrials.gov/show/NCT00000377
http://clinicaltrials.gov/show/NCT00177671
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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