Depression-Diabetes Mechanisms: Urban African Americans



Status:Completed
Conditions:Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 81
Updated:4/21/2016
Start Date:May 2004
End Date:May 2008

Use our guide to learn which trials are right for you!

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 process, depression may contribute to both the genesis of type 2
diabetes (through impact on neurohormonal activation, inflammatory mediators, and insulin
resistance), and difficulties in management (through decreased adherence to diet plans,
medication, and scheduled appointments). The preliminary data from the Grady Diabetes Clinic
indicates that depression may be common in African-Americans with diabetes, that depression
is a factor in non-adherence, and that non-adherence leads to poor glycemic control - a
direct cause of diabetes complications. What is not known is: how treatment of depression
could lead to both neurohormonal and psychobiological improvement, with improved patient
adherence and glycemic control.

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 depression, who will receive either: (i) computer-based cognitive behavioral
therapy (CBT) program entitled "Beating the Blues" + placebo, or (ii) computer-based
cognitive behavioral therapy (CBT) program entitled "Beating the Blues" + the SSRI
antidepressant escitalopram. The investigator will assess (a) glycemic control (levels of
glycated hemoglobin (HbA1c)), in relation to (b) adherence (keeping scheduled return
appointments, diet, exercise, and glucose monitoring), (c) depressive symptoms
(neurocognitive and neurobehavioral symptoms determined by self- and observer-rated scales),
and (d) the four pathways of neurometabolic function.

Study visits will occur once a month for 6 months. Should patients report severe
environmental stressors (such as marital conflict, loss of family member or job, being
exposed to trauma), patients will be offered an intensification of their contact with study
personnel, e.g. weekly contact by phone or "in-person" visits to see study personnel at the
Grady Diabetes Clinic.

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:

1. Bipolar Disorder

2. Schizophrenia or any Psychotic Disorder

3. Obsessive Compulsive Disorder

4. Mental Retardation or any Pervasive Developmental Disorder or Cognitive
Disorder.

5. Personality Disorder of sufficient severity to interfere with their
participation in the study

6. 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
We found this trial at
1
site
Atlanta, Georgia 30303
?
mi
from
Atlanta, GA
Click here to add this to my saved trials