Augmenting Antidepressant Treatment With Interpersonal Psychotherapy for Treating Late-life Depression
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Tracking Information | |||||
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First Received Date ICMJE | September 12, 2005 | ||||
Last Updated Date | January 10, 2012 | ||||
Start Date ICMJE | April 2004 | ||||
Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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. |
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Original Primary Outcome Measures ICMJE |
Combined treatment (escitalopram plus IPT)will lead to higher response and remission rates, and greater absolute improvement in Hamilton Rating Scale for Depression scores (administered weekly) over time, than escitalopram monotherapy. | ||||
Change History | Complete list of historical versions of study NCT00177294 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE |
Partial responders to escitalopram monotherapy will be characterized, at baseline, by higher rates of hopelessness (BHS) and suicidal ideation (Beck Scale for SI), greater levels of disability (MOS-SF) and cognitive impairment (MMSE, EXIT, MDRS). | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Augmenting Antidepressant Treatment With Interpersonal Psychotherapy for Treating Late-life Depression | ||||
Official Title ICMJE | Geriatric Depression: Getting Better, Getting Well | ||||
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. |
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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 |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Depression | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | 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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 319 | ||||
Completion Date | August 2009 | ||||
Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 60 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00177294 | ||||
Other Study ID Numbers ICMJE | R01 MH037869-01, R01MH037869, 0404007, DATR A4-GPS | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | University of Pittsburgh | ||||
Study Sponsor ICMJE | University of Pittsburgh | ||||
Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||
Investigators ICMJE |
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Information Provided By | University of Pittsburgh | ||||
Verification Date | November 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |