Depression-Diabetes Mechanisms: Urban African Americans
Diabetes, Depression
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria: Subjects must be English-speaking African American Have type 2 diabetes per American Diabetes Association criteria Patient's receiving care at Grady Hospital Exclusion Criteria: 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
Sites / Locations
- Grady Hospital Diabetes Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Beating the Blues CBT + Escitalopram
Beating the Blues CBT + Placebo
Subjects with type 2 diabetes will be randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
Subjects with type 2 diabetes will be randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months