|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | Paroxetine and Interpersonal Psychotherapy for Maintaining Health and Well-Being in Elderly Individuals With Depression | ||||
| Official Title † | Maintenance Therapies in Late-Life Depression 2 (MTLD-2) | ||||
| Brief Summary | 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. |
||||
| Detailed Description | 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:
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. |
||||
| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | 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. | ||||
| Secondary Outcome Measure † | 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 MRI |
||||
| Condition † | Unipolar Depression | ||||
| Intervention † | Behavioral: Interpersonal Psychotherapy Drug: paroxetine |
||||
| MEDLINE PMIDs | 16540613 | ||||
| Links | An online resource for older individuals with mental health needs ![]() |
||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 225 | ||||
| Start Date † | March 1999 | ||||
| Completion Date | August 2005 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 69 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00178100 | ||||
| Organization ID | R01 MH43832-02 | ||||
| Secondary IDs †† | 971156, DATR A4-GPS | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | University of Pittsburgh | ||||
| Investigators † |
|
||||
| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | September 2005 | ||||
| First Received Date † | September 13, 2005 | ||||
| Last Updated Date | May 2, 2006 | ||||