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

Primary Purpose

Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Interpersonal Psychotherapy
Clinical Monitoring
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Elderly, Remission, Escitalopram, Interpersonal Psychotherapy, Psychotherapy, Caregiving, Late-Life

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
January 10, 2012
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00177294
Brief Title
Augmenting Antidepressant Treatment With Interpersonal Psychotherapy for Treating Late-life Depression
Official Title
Geriatric Depression: Getting Better, Getting Well
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Elderly, Remission, Escitalopram, Interpersonal Psychotherapy, Psychotherapy, Caregiving, Late-Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
319 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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)
Arm Title
2
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy
Other Intervention Name(s)
IPT
Intervention Description
16 sessions of interpersonal psychotherapy (IPT)
Intervention Type
Behavioral
Intervention Name(s)
Clinical Monitoring
Intervention Description
16 weeks of depression care management(DCM). No psychotherapy will be provided.
Primary Outcome Measure Information:
Title
Remission
Description
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.
Time Frame
Measured at Week 6 or 22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles F. Reynolds III, MD
Organizational Affiliation
University of Pittsburgh Professor of Psychiatry, Neurology, and Neuroscience
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20957693
Citation
Reynolds CF 3rd, Dew MA, Martire LM, Miller MD, Cyranowski JM, Lenze E, Whyte EM, Mulsant BH, Pollock BG, Karp JF, Gildengers A, Szanto K, Dombrovski AY, Andreescu C, Butters MA, Morse JQ, Houck PR, Bensasi S, Mazumdar S, Stack JA, Frank E. Treating depression to remission in older adults: a controlled evaluation of combined escitalopram with interpersonal psychotherapy versus escitalopram with depression care management. Int J Geriatr Psychiatry. 2010 Nov;25(11):1134-41. doi: 10.1002/gps.2443.
Results Reference
result
PubMed Identifier
24144505
Citation
Andreescu C, Tudorascu DL, Butters MA, Tamburo E, Patel M, Price J, Karp JF, Reynolds CF 3rd, Aizenstein H. Resting state functional connectivity and treatment response in late-life depression. Psychiatry Res. 2013 Dec 30;214(3):313-21. doi: 10.1016/j.pscychresns.2013.08.007. Epub 2013 Oct 18.
Results Reference
derived

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

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