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

Unipolar Depression Clinical Trial

Official title:

Maintenance Therapies in Late-Life Depression 2 (MTLD-2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00178100
• Other study ID #: R01 MH043832-02
• Secondary ID: 971156DATR A4-GP
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: July 31, 2013
• Start date: March 1999
• Est. completion date: August 2005

Study information

• Verified date: July 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 69 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Unipolar Depression

Intervention

Behavioral:
• Interpersonal Psychotherapy

Drug:
• paroxetine

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cognitive status: Folstein Mini-Mental Status Exam, MATTIS Dementia Rating Scale, EXIT, and CDR
Secondary	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
Secondary	Social Support: Interpersonal Support Evaluation List, Luben Social Network Scale; and Life Events and Difficulties Schedule
Secondary	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
Secondary	MRI