Paroxetine and Interpersonal Psychotherapy for Maintaining Health and Well-being in Elderly Individuals With Depression
Primary Purpose
Unipolar Depression
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Psychotherapy
paroxetine
Sponsored by
About this trial
This is an interventional treatment trial for Unipolar Depression focused on measuring Depression, Elderly, Late Life
Eligibility Criteria
Inclusion Criteria: Age 69 or older meets DSM-IV criteria for current unipolar major depression HRSD (17 item) score of 15 or higher Folstein Mini Mental Status exam score of 18 or higher Exclusion Criteria: Lifetime diagnosis of any psychotic disorder or bipolar disorder alcohol or drug abuse within the past six months MATTIS Dementia Rating Score of 120 or less Contraindication to SSRI therapy Hyponatremia
Sites / Locations
- University of Pittsburgh Medical Center
Outcomes
Primary Outcome Measures
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 Measures
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
Full Information
NCT ID
NCT00178100
First Posted
September 13, 2005
Last Updated
July 31, 2013
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT00178100
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pittsburgh
4. Oversight
5. Study Description
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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unipolar Depression
Keywords
Depression, Elderly, Late Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
225 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy
Intervention Type
Drug
Intervention Name(s)
paroxetine
Primary Outcome Measure Information:
Title
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 Information:
Title
Cognitive status: Folstein Mini-Mental Status Exam, MATTIS Dementia Rating Scale, EXIT, and CDR
Title
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
Title
Social Support: Interpersonal Support Evaluation List, Luben Social Network Scale; and Life Events and Difficulties Schedule
Title
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
Title
MRI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 69 or older
meets DSM-IV criteria for current unipolar major depression
HRSD (17 item) score of 15 or higher
Folstein Mini Mental Status exam score of 18 or higher
Exclusion Criteria:
Lifetime diagnosis of any psychotic disorder or bipolar disorder
alcohol or drug abuse within the past six months
MATTIS Dementia Rating Score of 120 or less
Contraindication to SSRI therapy
Hyponatremia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles F Reynolds III, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16540613
Citation
Reynolds CF 3rd, Dew MA, Pollock BG, Mulsant BH, Frank E, Miller MD, Houck PR, Mazumdar S, Butters MA, Stack JA, Schlernitzauer MA, Whyte EM, Gildengers A, Karp J, Lenze E, Szanto K, Bensasi S, Kupfer DJ. Maintenance treatment of major depression in old age. N Engl J Med. 2006 Mar 16;354(11):1130-8. doi: 10.1056/NEJMoa052619.
Results Reference
result
PubMed Identifier
18457338
Citation
Carreira K, Miller MD, Frank E, Houck PR, Morse JQ, Dew MA, Butters' MA, Reynolds CF 3rd. A controlled evaluation of monthly maintenance interpersonal psychotherapy in late-life depression with varying levels of cognitive function. Int J Geriatr Psychiatry. 2008 Nov;23(11):1110-3. doi: 10.1002/gps.2031.
Results Reference
derived
Learn more about this trial
Paroxetine and Interpersonal Psychotherapy for Maintaining Health and Well-being in Elderly Individuals With Depression
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