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CompletedNCT00178100Updated Aug 2, 2013

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

A Phase 4 interventional study of Interpersonal Psychotherapy and paroxetine in Unipolar Depression, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 69 Years and older. Per ClinicalTrials.gov, last updated 2013-08-02.

Sponsored by University of Pittsburgh · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
225
Allocation
Randomized
Ages
69 Years and older
Sex
All
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Study 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.

Read the 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

02

Conditions studied

  • Unipolar Depression

Keywords

  • Depression
  • Elderly
  • Late Life
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 225 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
69 Years and older
Sexes eligible
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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double
Enrollment
225 participants

Interventions

  • BehavioralInterpersonal Psychotherapy
  • Drugparoxetine
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What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15213, United States
08

References and documents

Publications

  • 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. PubMed 16540613 ↗
  • 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. PubMed 18457338 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00178100
Lead sponsor
University of Pittsburgh
First posted
Sep 15, 2005
Start date
Mar 1999
Completion
Aug 2005
Last update
Aug 2, 2013

Study contacts

Charles F Reynolds III, MD
principal investigator · University of Pittsburgh
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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