Paroxetine and Interpersonal Psychotherapy for Maintaining Health and Well-being in Elderly Individuals With Depression

July 31, 2013 updated by: University of Pittsburgh

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment

225

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

69 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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 Measures

Outcome Measure
MRI
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Charles F Reynolds III, MD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1999

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

July 31, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH043832-02 (U.S. NIH Grant/Contract)
  • DATR A4-GPS
  • 971156

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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