Official Title: “Improving the Effectiveness of Treatment for Depression in Hispanics”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment

Study Primary Completion Date: January 2013

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Retention in evidence-based treatment
  • Time Frame: Measured at 3 months and 1 year
    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
    Safety Issue?: No

Secondary Measures

• Treatment Adherence and Retention Questionnaire (TARQ)
  • Time Frame: Measured at Weeks -1,12, 24, and 52
    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
    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
    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
    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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Carlos Blanco, MD, PhD Principal Investigator New York State Psychiatric Institute  

Overall Contact: Carlos Blanco, MD, PhD 212-543-6533 cb255@columbia.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00742573

Study ID Number: R01 MH076051

ClinicalTrials.gov Identifier: NCT00742573

Health Authority: United States: Federal Government