Status:
COMPLETED
Depression-Diabetes Mechanisms: Urban African Americans
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Diabetes
Depression
Eligibility:
All Genders
18-81 years
Phase:
PHASE4
Brief Summary
African-Americans suffer from increased prevalence of both type 2 diabetes and diabetes complications, reflecting a combination of psychobehavioral factors as well as metabolic dysfunction. In this pr...
Detailed Description
To determine the psychobehavioral and neurohormonal mechanisms of effective treatment, the investigator will conduct a randomized, double-blind, placebo-controlled trial in patients with major depress...
Eligibility Criteria
Inclusion
- Subjects must be English-speaking
- African American
- Have type 2 diabetes per American Diabetes Association criteria
- Patient's receiving care at Grady Hospital
Exclusion
- Severely depressed (Hamilton Depression Rating Scale (HAM-D) ≥ 34
- Non - English speaking
- Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
- currently meet Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for:
- Bipolar Disorder
- Schizophrenia or any Psychotic Disorder
- Obsessive Compulsive Disorder
- Mental Retardation or any Pervasive Developmental Disorder or Cognitive Disorder.
- Personality Disorder of sufficient severity to interfere with their participation in the study
- Psychotic features or with history of Psychotic Disorder, as defined by DSM-IV
- Suicide risk, or have made serious suicide attempt in the past year
- Substance Abuse or Dependence (other than nicotine) during the six months preceding the first dose of double blind study medication
- Any malignancy (other than excised basal cell carcinoma), or any clinically significant hematological, endocrine, cardiovascular (including any rhythm disorder), renal, hepatic, gastrointestinal, or neurological disease. History of syndrome of inappropriate anti-diuretic hormone secretion.
- Diabetes due to: glucagonoma, pheochromocytoma or other endocrine neoplasm, drug induced diabetes, gestational diabetes, or those with established genetic defects of beta cell function.
- Medical conditions that will interfere with the HbA1c assay or if hospitalization is likely within two months (sickle cell anemia, hypersplenism)
- A history of diabetic ketoacidosis episode during the 6 months preceding the first dose of double-blind study medication.
- Uncontrolled diabetes as judged by the investigator defined as blood glucose greater than 400 on last two visits or patients whom suffered from diabetic ketoacidosis in the last month or have had 2 episodes in the last year.
- Autonomic or peripheral neuropathy that requires treatment
- At the first follow-up visit - Patients with systolic blood pressure greater than 180 mm Hg or less than 90 mm Hg or diastolic blood pressure greater than 105 mm Hg or less than 50 mm Hg
- Treatment with a depot neuroleptic during the last 6 months
- Patients who have been treated with any neuroleptic, antidepressant, or anxiolytic medication
- Participation in an investigational drug study within 1 month prior to study entry or who have received treatment with an investigational drug within 1 month or five half-lives, whichever is longer.
- Previous investigational study of escitalopram or previously treated with escitalopram in a dose and duration sufficient for therapeutic trial.
- History of hypersensitivity reaction to escitalopram or citalopram.
- Electroconvulsive therapy during the past 3 months
- Initiation or termination of behavior therapy or psychotherapy in the 3 months.
- Positive urine screening for alcohol, illicit drugs, or any prohibited medication
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00209170
Start Date
May 1 2004
End Date
May 1 2008
Last Update
July 29 2015
Active Locations (1)
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1
Grady Hospital Diabetes Clinic
Atlanta, Georgia, United States, 30303