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

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ClinicalTrials.gov Identifier: NCT00178100
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : August 2, 2013
Information provided by:
University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Unipolar Depression Behavioral: Interpersonal Psychotherapy Drug: paroxetine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Maintenance Therapies in Late-Life Depression 2 (MTLD-2)
Study Start Date : March 1999
Study Completion Date : August 2005

Primary Outcome Measures :
  1. 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 :
  1. Cognitive status: Folstein Mini-Mental Status Exam, MATTIS Dementia Rating Scale, EXIT, and CDR
  2. 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
  3. Social Support: Interpersonal Support Evaluation List, Luben Social Network Scale; and Life Events and Difficulties Schedule
  4. 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
  5. MRI

Information from the National Library of Medicine

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Ages Eligible for Study:   69 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178100

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United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
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Principal Investigator: Charles F Reynolds III, MD University of Pittsburgh
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00178100    
Other Study ID Numbers: R01MH043832-02 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: July 2013
Keywords provided by University of Pittsburgh:
Late Life
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors