Official Title: “Motivational Antidepressant Therapy for Hispanics”

This study will evaluate the effectiveness of adding motivational interviewing to antidepressant treatment for major depressive disorder in Hispanic adults.

Study Type: Interventional

Study Design: Health Services Research, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: July 2012

Depression is a serious illness that affects a person's mood, thoughts, and physical well-being. There are multiple types of depressive disorders, with major depressive disorder (MDD) being one of the most common. The following symptoms may be signs of MDD: persistent feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; disinterest in previously enjoyed activities; excessive irritability and restlessness; suicidal thoughts; and inability to concentrate. Despite the widespread use of drug treatment for MDD in the United States, it continues to be underutilized in the Hispanic population.

The retention rate in antidepressant therapy (ADT) among the Hispanic population is half that of the Caucasian population. It is believed that cultural factors and ambivalence toward seeking treatment interfere with ADT retention in Hispanic adults. Motivational antidepressant therapy (MADT) involves the use of motivational interviewing (MI) to discuss treatment with patients. This study will compare the effectiveness of culturally-specific MADT versus standard antidepressant therapy (SADT) in treating Hispanic adults with MDD.

Participants in this single-blind study will be randomly assigned to receive either MADT or SADT. A psychiatrist will conduct all medication visits and will recommend an initial antidepressant for each participant. Depending on treatment assignment, psychiatrists will use either the MADT or SADT approach in the medication visits. During the visits, participants will complete questionnaires, undergo vital sign measurements, and receive medication.

Medication visits will occur weekly during the first two weeks, every 2 weeks for the next 6 weeks, and then on a monthly basis until the end of the study. In addition to visits with the psychiatrist, participants will complete 15-minute individual interviews with a clinician from the Hispanic Treatment Program. Individual interviews will take place every 2 weeks in the first month of treatment, monthly until the third month, and then every other month thereafter. The association between treatment, retention, and response will be assessed after 3 months of treatment. Preliminary outcome data will be obtained after 6 more months of continued treatment. After the end of treatment, participants may randomly be asked to participate in a small "focus group" to discuss personal experiences with study treatments.

Intervention(s) in this Clinical Trial

• Drug: Standard antidepressant therapy (SADT)
  • Treatment with medication will follow the Texas Medication Algorithm (TMA) for Depression. Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR), bupropion SR (Wellbutrin SR), duloxetine (Cymbalta), nortriptyline (Pamelor), and mirtazapine (Remeron).
• Behavioral: Motivational antidepressant therapy (MADT)
  • The same medication treatment for depression will be offered and supplemented with techniques from motivational interviewing.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Participants will receive standard antidepressant therapy
• Experimental: 2
  • Participants will receive motivational antidepressant therapy

Primary Measures

• Number of days in ADT (retention)
  • Time Frame: Measured at Months 3 and 9
    Safety Issue?: No
• HAMD-17 (symptoms)
  • Time Frame: Measured at Months 3 and 9
    Safety Issue?: No
• Sheehan Disability Scale (impairment)
  • Time Frame: Measured at Months 3 and 9
    Safety Issue?: No
• Q-LES-Q (quality of life)
  • Time Frame: Measured at Months 3 and 9
    Safety Issue?: No

Secondary Measures

• Client Satisfaction Questionnaire (patient satisfaction)
  • Time Frame: Measured at Months 3 and 9
    Safety Issue?: No
• Composite Adherence Score (medication adherence)
  • Time Frame: Measured at Months 3 and 9
    Safety Issue?: No

Inclusion Criteria:

• Self-identifies as Hispanic
• Meets DSM-IV criteria for major depressive disorder (MDD)
• Score of 16 or higher on Hamilton Depression Scale (HAM-D17) at study entry
• Willing to abstain from other psychotropic medications not included in the Texas
• Medication Algorithm (TMA) for depression, as clinically indicated, for the duration of the study. Zolpidem for insomnia will be allowed.
• Fluency in English or Spanish

Exclusion Criteria:

• Acute suicidality
• History of schizophrenia, bipolar affective disorder, schizoaffective disorder, depression with psychotic features, or organic brain syndromes
• Alcohol or other substance abuse or dependence (except nicotine) within 6 months prior to study entry
• Clinically unstable medical disease, including narrow-angle glaucoma or increased intra-ocular pressure
• Systemic blood pressure of 150/90 mm Hg or less
• Liver function test values two times above the normal level
• Pregnant or breastfeeding
• Sexually active women not using an effective method of birth control
• Current or past history of seizure disorder (except febrile seizure in childhood)
• Receiving effective medication for MDD
• Unable to tolerate or unwilling to accept drug-free period of varying length: 1 week for PRN benzodiazepines; 2 weeks for buspirone, lithium, anticonvulsants, stimulants, barbiturates, opiates, and regular-use benzodiazepines (except clonazepam); and 5 weeks for clonazepam
• Received electroconvulsive therapy (ECT) within 3 months prior to study entry
• Parkinson's disease, dementia of any type, or cognitive impairment

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 79 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Roberto Lewis-Fernandez, MD Principal Investigator New York State Psychiatric Institute  

Overall Contact: Roberto Lewis-Fernandez, MD 212-543-6512 rlewis@nyspi.cpmc.columbia.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00564278

Study ID Number: R01 MH077226

ClinicalTrials.gov Identifier: NCT00564278

Health Authority: United States: Federal Government