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

Study Description

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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.

For information on related studies, please follow these links:

http://clinicaltrials.gov/show/NCT00000377

http://clinicaltrials.gov/show/NCT00177671

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator:	Charles F Reynolds III, MD	University of Pittsburgh

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00178100 History of Changes
Other Study ID Numbers:	R01MH043832-02 ( U.S. NIH Grant/Contract ); 971156; DATR A4-GPS
First Posted:	September 15, 2005
Last Update Posted:	August 2, 2013
Last Verified:	July 2013

Keywords provided by University of Pittsburgh:

Depression; Elderly; Late Life

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Paroxetine; 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