Augmenting Antidepressant Treatment With Interpersonal Psychotherapy for Treating Late-life Depression
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Purpose
This study will determine whether adding interpersonal psychotherapy to treatment with the antidepressant escitalopram will be more effective in reducing symptoms of depression than antidepressant medication alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: Escitalopram Behavioral: Interpersonal Psychotherapy Behavioral: Clinical Monitoring |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Geriatric Depression: Getting Better, Getting Well |
- Remission [ Time Frame: Measured at Week 6 or 22 ] [ Designated as safety issue: No ]Three consecutive weekly scores of less than 7 on the Hamilton Rating Scale for Depression (N=17 item). Scores on the Hamilton Rating Scale for Depression(HRSD) range from 0 to 58, with higher scores indicating more severe depression.
| Enrollment: | 319 |
| Study Start Date: | April 2004 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
|
Drug: Escitalopram
Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks.
Other Name: Lexapro
Behavioral: Interpersonal Psychotherapy
16 sessions of interpersonal psychotherapy (IPT)
Other Name: IPT
|
|
Active Comparator: 2
Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management(DCM) without interpersonal psychotherapy (IPT)
|
Drug: Escitalopram
Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks.
Other Name: Lexapro
Behavioral: Clinical Monitoring
16 weeks of depression care management(DCM). No psychotherapy will be provided.
|
Detailed Description:
The purpose of this research study is to learn if adding psychotherapy (Interpersonal Psychotherapy) to antidepressant medication (escitalopram), will be more effective in reducing lingering symptoms of depression and decreasing the burden of these symptoms, when initial treatment with just antidepressant medication alone has led to only a partial response. Participation in the study will last up to 22 weeks.
Because fewer than 50% of elderly depressed patients achieve remission and recovery in response to first-line antidepressant pharmacotherapy, the majority of patients are left with significant symptoms and functional impairment, putting them at risk of chronic, relapsing illness, non-adherence to other medical treatment, suicide, and family caregiver burden. We will recruit and treat 320 patients with unipolar major depression aged 60 and older, using clinical management with escitalopram 10 mg/day for six weeks. Patients who are partial responders to escitalopram plus clinical management will be randomly assigned to 16 weeks of extension therapy with either 20 mg escitalopram plus clinical management or 20 mg escitalopram plus Interpersonal Psychotherapy (IPT, 16 sessions). Changes over time in measures of depressive symptoms, hopelessness, suicidal ideation, disability, and family caregiving burden will be assessed. This study will answer the question of how best to treat partial responders-by simply extending pharmacotherapy at higher doses, or by also adding psychotherapy-to remission and recovery.
For information on related studies, please follow these links:
http://clinicaltrials.gov/show/NCT00178035
http://clinicaltrials.gov/show/NCT00178074
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of unipolar major depression
- Hamilton Rating Scale for Depression (HRSD) (17 item) score of 15 or higher
- Speaks English
- Willing to discontinue other psychotropic medications
- Availability of family member or other caregiver
- Hearing capacity adequate to respond to a raised conversational voice
Exclusion Criteria:
- Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or any psychotic disorder
- Folstein Mini-Mental Status Exam (MMSE) of 17 or lower
- Suicidal
- History of treatment non-adherence in other Center protocols
- History of documented non-response to citalopram in other Center protocols
- History of non-tolerance to escitalopram therapy
Contacts and Locations| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Charles F. Reynolds III, MD | University of Pittsburgh Professor of Psychiatry, Neurology, and Neuroscience |
More Information
Additional Information:
Publications:
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00177294 History of Changes |
| Other Study ID Numbers: | R01 MH037869-01, R01MH037869, 0404007, DATR A4-GPS |
| Study First Received: | September 12, 2005 |
| Results First Received: | December 22, 2010 |
| Last Updated: | January 10, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Pittsburgh:
|
Elderly Remission Escitalopram Interpersonal Psychotherapy |
Psychotherapy Caregiving Late-Life |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Antidepressive Agents Citalopram Dexetimide Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antiparkinson Agents Anti-Dyskinesia Agents |
Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 23, 2013