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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00742573 |
This study will determine whether combination treatment driven by patient choice is better than standardized medication treatment at retaining and improving Hispanic patients with major depressive disorder.
Condition | Intervention | Phase |
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Major Depressive Disorder |
Drug: Antidepressants through Texas Medication Algorithm (TMA) Behavioral: Brief Interpersonal Psychotherapy (IPT-B) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment |
Official Title: | Improving the Effectiveness of Treatment for Depression in Hispanics |
Estimated Enrollment: | 170 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | January 2013 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 Texas Medication Algorithm: Active Comparator
Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression
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Drug: Antidepressants through Texas Medication Algorithm (TMA)
Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.
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2 Patient Choice: Experimental
Participants will be offered brief interpersonal psychotherapy (IPT-B) alone or combined with the TMA for depression
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Drug: Antidepressants through Texas Medication Algorithm (TMA)
Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.
Behavioral: Brief Interpersonal Psychotherapy (IPT-B)
IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems.
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Major depressive disorder (MDD) prevents an individual from functioning normally, with symptoms like irritability, fatigue, and inability to feel pleasure interfering with school, work, and family life. Treating this disorder in Hispanics is particularly difficult, because they drop treatment two to three times more frequently than European Americans. Evidence suggests that depressed Hispanics prefer treatment of psychotherapy or combined psychotherapy and medication to treatment of medications alone. This study will determine whether offering depressed Hispanics a choice in their treatment option is more effective and results in a higher treatment retention than does prescribing treatment by medication only.
All participants will be randomly assigned to one of two groups for treating their depression. The first group will act as a control group, in which participants will receive 12 weeks of acute medication treatment for MDD according to the Texas Medication Algorithm (TMA). They may receive one of several anti-depressant medications according to this algorithm, including citalopram, escitalopram, paroxetine, sertraline, and others. Each participant in the second group will receive 12 weekly sessions of brief interpersonal psychotherapy (IPT-B), with the option of adding TMA-scheduled medication at any time, as part of a treatment derived in consultation with his or her therapist. Timing of study visits will also be flexible, as participants will be encouraged to continue with MDD treatments. All participants will continue to be examined for 9 months after receiving treatment for this study to determine whether they have continued in MDD treatment. Study visits, where measurements will be taken, will be at screening; at baseline; and at Weeks 4, 8, 12, 16, 24, 32, 40, 48, and 52. All participants will be assessed through clinical interviews and self-report measures for depression symptoms, adherence to treatment, cultural orientation, discrimination and stigma related to treatment, and satisfaction with treatment.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Carlos Blanco, MD, PhD | 212-543-6533 | cb255@columbia.edu |
Contact: Donna Vermes, RN | 212-543-6534 | donna@nyspi.cpmc.columbia.edu |
United States, New York | |
New York State Psychiatric Institute | Recruiting |
New York, New York, United States, 10032 | |
Contact: Mayumi Okuda 212-543-5132 okudama@nyspi.cpmc.columbia.edu | |
Principal Investigator: Carlos Blanco, MD, PhD |
Principal Investigator: | Carlos Blanco, MD, PhD | New York State Psychiatric Institute |
Responsible Party: | New York State Psychiatric Institute ( Carlos Blanco ) |
Study ID Numbers: | R01 MH076051, DSIR 83-ATSO |
Study First Received: | August 25, 2008 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00742573 |
Health Authority: | United States: Federal Government |
Major Depressive Disorder Mood Disorders Hispanic |
Depression Depressive Disorder, Major Urinary Retention Depressive Disorder Mirtazapine Citalopram Paroxetine Duloxetine |
Behavioral Symptoms Mental Disorders Nortriptyline Venlafaxine Bupropion Mood Disorders Sertraline Dexetimide |