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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00178100
First Posted: September 15, 2005
Last Update Posted: August 2, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Pittsburgh
September 13, 2005
September 15, 2005
August 2, 2013
March 1999
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00178100 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Paroxetine and Interpersonal Psychotherapy for Maintaining Health and Well-being in Elderly Individuals With Depression
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.

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

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Unipolar Depression
  • Behavioral: Interpersonal Psychotherapy
  • Drug: paroxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
August 2005
Not Provided

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
Sexes Eligible for Study: All
69 Years and older   (Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00178100
R01MH043832-02( U.S. NIH Grant/Contract )
971156
DATR A4-GPS
Not Provided
Not Provided
Not Provided
Not Provided
University of Pittsburgh
Not Provided
Principal Investigator: Charles F Reynolds III, MD University of Pittsburgh
University of Pittsburgh
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP