Lithium, Extended-Release |
Eskalith CR; Lithobid |
Clinical Trial: Improving Hispanic Retention in Antidepressant Therapy
This study is currently recruiting patients.
|
Purpose
The purpose of this study is to develop an intervention that will increase the retention of Hispanics with major depression in antidepressant therapy.
| Condition | Treatment or Intervention |
|---|---|
| Depression Depressive Disorder | Drug: Sertraline Drug: Venlafaxine Extended Release |
MedlinePlus related topics: Depression; Mental Health
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Expected Total Enrollment: 80
Study start: September 2002; Expected completion: August 2005
Despite major advances in the treatment of psychiatric disorders, Hispanics continue to underutilize mental health services relative to their own mental health needs. Cultural factors are important causes of underutilization. To date, however, attempts to boost utilization by improving the cultural congruence of psychiatric services have not focused on retaining Hispanics in antidepressant therapy.
Motivational Interviewing (MI) is a time-limited psychotherapy that has successfully improved treatment retention among patients with dually diagnosed substance abuse and psychiatric disorders. During Phase I of this study, MI is adapted for use as an adjunctive therapy with antidepressant treatment and culturally adapted to Hispanic participants. In Phase II, participants receive sertraline for 12 weeks and participate in four sessions of MI therapy as a supplementary intervention designed to encourage treatment retention. Participants who are intolerant to sertraline or have an inadequate response by Week 6 are switched to venlafaxine ER while continuing to receive MI and to complete study assessments. A follow-up interview is conducted 6 months after the termination of treatment.
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- DSM-IV criteria for Major Depressive Disorder
- Patients who self-identify as Hispanic and are Spanish-dominant, English-dominant, or bilingual
- Acceptable methods of contraception
- Hamilton Depression Rating Scale score >= 18 at Visit 1
- Sertraline or venlafaxine ER is clinically appropriate
Exclusion Criteria:
- History of schizophrenia, bipolar affective disorder, schizoaffective disorder, depression with psychotic symptoms, or organic brain syndrome
- DSM-IV criteria for alcohol or substance abuse or dependence during the 6 months prior to screening
- Pregnancy or breast-feeding
- At risk for committing suicide
- Clinically significant renal, pulmonary, cerebrovascular, cardiovascular, gastrointestinal, or endocrine disorders
- Glaucoma, history of increased intraocular pressure (IOP), or at risk for having increased IOP
- Untreated or unstable hypertension
- Clinically significant laboratory abnormalities or abnormal electrocardiogram
- Medical conditions that might interfere with the process of drug absorption, metabolism, or elimination
- Clinically significant thyroid dysfunction (except patients who are stable and asymptomatic on thyroid replacement therapy)
- Current or past history of seizure disorder (except febrile seizure in childhood)
- History of failed sertraline or venlafaxine treatment for at least 4 weeks at adequate doses
- Allergy or hypersensitivity to sertraline or venlafaxine
- History of two failed selective serotonin reuptake inhibitor (SSRI) trials for major depression at adequate doses and duration
- Monoamine oxidase inhibitors (MAOIs) or fluoxetine within 4 weeks prior to screening, or other SSRIs, antidepressants, neuroleptics, mood stabilizers, buspirone, benzodiazepines, or other psychotropic drugs (except zolpidem for insomnia) within 2 weeks prior to screening
- Electroconvulsive Therapy (ECT) within the last 3 months
- Effective medication or psychotherapy
Location and Contact Information
Donna Vermes, RN 212-543-6534 donna@nyspi.cpmc.columbia.edu
New York
New York State Psychiatric Institute, New York, New York, 10032, United States; Recruiting
Donna Vermes, RN 212-543-6534 donna@nyspi.cpmc.columbia.edu
Roberto Lewis-Fernandez, MD, Principal Investigator
Cesar Alfonso, MD, Sub-Investigator
Carlos Blanco, MD, PhD, Sub-Investigator
J. Arturo Sanchez-Lacay, MD, MPH, Sub-Investigator
Ivan Balan, PhD, Sub-Investigator
Roberto Lewis-Fernandez, MD, Principal Investigator, Columbia University, NY State Psychiatric Institute
More Information
Record last reviewed: March 2005
Last Updated: March 2, 2005
Record first received: April 4, 2003
ClinicalTrials.gov Identifier: NCT00057642
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Eskalith CR (Drug Digest)
- Lithium, Extended-Release (Drug Digest)

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