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Incorporating Patient Treatment Choice to Improve Treatment Retention in Depressed Hispanics
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), September 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00742573
  Purpose

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
Major Depressive Disorder
Drug: Antidepressants through Texas Medication Algorithm (TMA)
Behavioral: Brief Interpersonal Psychotherapy (IPT-B)
Phase II

MedlinePlus related topics: Depression
Drug Information available for: Sertraline hydrochloride Sertraline Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Paroxetine Paroxetine hydrochloride Paroxetine Mesylate Bupropion hydrochloride Bupropion Mirtazapine Venlafaxine Venlafaxine hydrochloride Duloxetine Duloxetine hydrochloride Nortriptyline Nortriptyline hydrochloride
U.S. FDA Resources
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

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Retention in evidence-based treatment [ Time Frame: Measured at 3 months and 1 year ] [ Designated as safety issue: No ]
  • Hamilton Depression Scale (HAMD-17) [ Time Frame: Measured at baseline and at Weeks 1, 4, 8, 12, 16, 24, 32, 40, 48, and 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment Adherence and Retention Questionnaire (TARQ) [ Time Frame: Measured at screening and at Weeks 12, 24, and 52 ] [ Designated as safety issue: No ]
  • Client Satisfaction Questionnaire (CSQ) [ Time Frame: Measured at baseline and at Weeks 4, 8, 12, 16, 24, 32, 40, 48, and 52 ] [ Designated as safety issue: No ]
  • Perceived Need for Care Questionnaire (PNCQ) [ Time Frame: Measured at baseline and at Weeks 4, 8, 12, 16, 24, 32, 40, 48, and 52 ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale (SDS) [ Time Frame: Measured at baseline and at Weeks 4, 8, 12, 16, 24, 32, 40, 48, and 52 ] [ Designated as safety issue: No ]
  • Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Measured at baseline and at Weeks 4, 8, 12, 16, 24, 32, 40, 48, and 52 ] [ Designated as safety issue: No ]

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
1 Texas Medication Algorithm: Active Comparator
Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression
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.
2 Patient Choice: Experimental
Participants will be offered brief interpersonal psychotherapy (IPT-B) alone or combined with the TMA for depression
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hispanic
  • DSM-IV criteria for non-psychotic major depressive disorder (MDD) of at least moderate severity (Hamilton Depression Score greater than 18)

Exclusion Criteria:

  • At risk of attempting suicide
  • Unstable medical illness
  • History of bipolar disorder, schizophrenia, or other psychotic disorder
  • Pregnant or lactating
  • Alcohol or substance use disorder that requires acute detoxification
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742573

Contacts
Contact: Carlos Blanco, MD, PhD 212-543-6533 cb255@columbia.edu
Contact: Donna Vermes, RN 212-543-6534 donna@nyspi.cpmc.columbia.edu

Locations
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            
Sponsors and Collaborators
Investigators
Principal Investigator: Carlos Blanco, MD, PhD New York State Psychiatric Institute
  More Information

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

Keywords provided by National Institute of Mental Health (NIMH):
Major Depressive Disorder
Mood Disorders
Hispanic

Study placed in the following topic categories:
Depression
Depressive Disorder, Major
Urinary Retention
Depressive Disorder
Mirtazapine
Citalopram
Paroxetine
Duloxetine
Behavioral Symptoms
Mental Disorders
Nortriptyline
Venlafaxine
Bupropion
Mood Disorders
Sertraline
Dexetimide

ClinicalTrials.gov processed this record on January 30, 2009