Paroxetine and Interpersonal Psychotherapy for Maintaining Health and Well-Being in Elderly Individuals With Depression
This study has been completed.
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00178100
First received: September 13, 2005
Last updated: February 19, 2009
Last verified: February 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Unipolar Depression |
Behavioral: Interpersonal Psychotherapy Drug: paroxetine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Maintenance Therapies in Late-Life Depression 2 (MTLD-2) |
Resource links provided by NLM:
MedlinePlus related topics:
Depression
Drug Information available for:
Paroxetine
Paroxetine hydrochloride
Paroxetine hydrochloride hemihydrate
Paroxetine Mesylate
U.S. FDA Resources
Further study details as provided by National Institute of Mental Health (NIMH):
Primary Outcome Measures:
- 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:
- 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
| Estimated Enrollment: | 225 |
| Study Start Date: | March 1999 |
| Estimated Study Completion Date: | August 2005 |
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
Eligibility| Ages Eligible for Study: | 69 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178100
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
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00178100 History of Changes |
| Other Study ID Numbers: | R01 MH043832-02, 971156, DATR A4-GPS |
| Study First Received: | September 13, 2005 |
| Last Updated: | February 19, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Depression Elderly Late Life |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Paroxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013