Improving Retention of Hispanics Receiving Antidepressant Therapy

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will develop an intervention that will increase the retention of Hispanics with major depression in antidepressant therapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Antidepressive Agents; Sertraline; Venlafaxine Hydrochloride

Criteria

Inclusion Criteria:

• Diagnostic Statistical Manual, 4th edition 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