Depression-Diabetes Mechanisms: Urban African Americans

NCT00209170 | Completed Phase 4 Results DMC

• 2 other identifiers: IRB00001092R01MH069254-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetes; Depression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Beating the Blues CBT + Escitalopram

EXPERIMENTAL

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

Behavioral: Beating the Blues; Drug: Escitalopram

Beating the Blues CBT + Placebo

ACTIVE COMPARATOR

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

Behavioral: Beating the Blues; Drug: Placebo

Interventions

Beating the Blues BEHAVIORAL

Beating the Blues is a computerized cognitive behavioral therapy.

Beating the Blues CBT + Escitalopram; Beating the Blues CBT + Placebo

Escitalopram DRUG

Escitalopram is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It's a 10 mg pill taken once or twice daily for 6 months.

Also known as: Lexapro

Beating the Blues CBT + Escitalopram

Placebo DRUG

A sugar pill taken as one to two tablets daily for 6 months.

Beating the Blues CBT + Placebo

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be English-speaking
• African American
• Have type 2 diabetes per American Diabetes Association criteria
• Patient's receiving care at Grady Hospital

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Grady Hospital Diabetes Clinic

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dominique Musselman, MD
• Organization: University of Miami School of Medicine

dmusselman@med.miami.edu

404-723-8361

Study Officials

• Dominique L Musselman, MD, MS

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 21, 2005
• Study Start: May 1, 2004
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: July 29, 2015
• Results First Posted: July 29, 2015

Record last verified: 2015-07

Locations

US (1)