Paroxetine and Interpersonal Psychotherapy for Maintaining Health and Well-being in Elderly Individuals With Depression
|ClinicalTrials.gov Identifier: NCT00178100|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : August 2, 2013
|Condition or disease||Intervention/treatment||Phase|
|Unipolar Depression||Behavioral: Interpersonal Psychotherapy Drug: paroxetine||Phase 4|
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.
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|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||225 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Maintenance Therapies in Late-Life Depression 2 (MTLD-2)|
|Study Start Date :||March 1999|
|Estimated Study Completion Date :||August 2005|
- 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.
- Cognitive status: Folstein Mini-Mental Status Exam, MATTIS Dementia Rating Scale, EXIT, and CDR
- Quality of Life measures: Quality of Wellbeing Scale, CIDI Health Services Utilization, Older American Resources and Services Activities of Daily Living Scale, Global Assessment Scale, PSQI, SF-36, UKU, and CIRS-G
- Social Support: Interpersonal Support Evaluation List, Luben Social Network Scale; and Life Events and Difficulties Schedule
- Psychiatric status: SCID, Hamilton Depression Rating Scale, Suicidal History Questionnaire, Antidepressant Treatment History Form, Brief Psychiatric Rating Scale, and anxiety subscale of Brief Symptom Inventory
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178100
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Charles F Reynolds III, MD||University of Pittsburgh|