Depression-Diabetes Mechanisms: Urban African Americans

Depression Clinical Trial

Official title:

Depression-Diabetes Mechanisms: Urban African Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00209170
• Other study ID #: IRB00001092
• Secondary ID: R01MH069254-03
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: July 27, 2015
• Start date: May 2004
• Est. completion date: May 2008

Study information

• Verified date: July 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 81 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Diabetes

Intervention

Behavioral:
• Beating the Blues
Beating the Blues is a computerized cognitive behavioral therapy.

Drug:
• Escitalopram
Escitalopram is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It's a 10 mg pill taken once or twice daily for 6 months.
• Placebo
A sugar pill taken as one to two tablets daily for 6 months.

Locations

Country	Name	City	State
United States	Grady Hospital Diabetes Clinic	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week 24	The 21-item HDRS measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60, where higher scores indicate greater severity. The HDRS at week 24 was compared to the baseline HDRS and each participant's response was calculated using the below table: No Response = < 25% change in Depression Rating Scale Score Partial Responder =< 50% to >25% change in Depression Rating Scale Score Responder = 50% or greater change in Depression Rating Scale Score	Baseline, week 24	No