Paroxetine and Interpersonal Psychotherapy for Maintaining Health and Well-being in Elderly Individuals With Depression
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ClinicalTrials.gov Identifier: NCT00178100 |
Recruitment Status :
Completed
First Posted : September 15, 2005
Last Update Posted : August 2, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Unipolar Depression | Behavioral: Interpersonal Psychotherapy Drug: paroxetine | Phase 4 |
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 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 |

- 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.
- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178100
United States, Pennsylvania | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Charles F Reynolds III, MD | University of Pittsburgh |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00178100 |
Other Study ID Numbers: |
R01MH043832-02 ( U.S. NIH Grant/Contract ) 971156 DATR A4-GPS |
First Posted: | September 15, 2005 Key Record Dates |
Last Update Posted: | August 2, 2013 |
Last Verified: | July 2013 |
Depression Elderly Late Life |
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 |