Paroxetine and Interpersonal Psychotherapy for Maintaining Health and Well-Being in Elderly Individuals With Depression - Tabular View

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

This study has been completed.

Study NCT00178100. Last updated on May 2, 2006. Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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

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.

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

Primary 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 Measure ^†

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

Condition ^†

Unipolar Depression

Intervention ^†

Behavioral: Interpersonal Psychotherapy
Drug: paroxetine

MEDLINE PMIDs

16540613

Links

An online resource for older individuals with mental health needs This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

225

Start Date ^†

March 1999

Completion Date

August 2005

Eligibility Criteria ^†

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

Gender

Both

Ages

69 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00178100

Organization ID

R01 MH43832-02

Secondary IDs ^††

971156, DATR A4-GPS

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

University of Pittsburgh

Investigators ^†

Principal Investigator:

Charles F Reynolds III, MD

University of Pittsburgh

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

September 2005

First Received Date ^†

September 13, 2005

Last Updated Date

May 2, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.