Augmenting Antidepressant Treatment With Interpersonal Psychotherapy for Treating Late-life Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Geriatric Depression: Getting Better, Getting Well

Conditions
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Depression

Intervention / Treatment
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* Drug: Escitalopram
* Behavioral: Interpersonal Psychotherapy
* Behavioral: Clinical Monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks.<br>* Other names: Lexapro;Behavioral: Interpersonal Psychotherapy<br>* 16 sessions of interpersonal psychotherapy (IPT)<br>* Other names: IPT;|
| Active Comparator: 2<br>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<br>* Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks.<br>* Other names: Lexapro;Behavioral: Clinical Monitoring<br>* 16 weeks of depression care management(DCM). No psychotherapy will be provided.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission | 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. | Measured at Week 6 or 22 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Remission, Escitalopram, Interpersonal Psychotherapy, Psychotherapy, Caregiving, Late-Life