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Depression-Diabetes Mechanisms: Urban African Americans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00209170
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : July 29, 2015
Last Update Posted : July 29, 2015
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Dominique Musselman, Emory University

Tracking Information
First Submitted Date  ICMJE September 14, 2005
First Posted Date  ICMJE September 21, 2005
Results First Submitted Date  ICMJE June 23, 2015
Results First Posted Date  ICMJE July 29, 2015
Last Update Posted Date July 29, 2015
Study Start Date  ICMJE May 2004
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2015)
Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week 24 [ Time Frame: Baseline, 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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Depression-Diabetes Mechanisms: Urban African Americans
Official Title  ICMJE Depression-Diabetes Mechanisms: Urban African Americans
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.
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Depression
Intervention  ICMJE
  • 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.
    Other Name: Lexapro
  • Drug: Placebo
    A sugar pill taken as one to two tablets daily for 6 months.
Study Arms  ICMJE
  • Experimental: Beating the Blues CBT + Escitalopram
    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
    Interventions:
    • Behavioral: Beating the Blues
    • Drug: Escitalopram
  • Active Comparator: Beating the Blues CBT + Placebo
    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
    Interventions:
    • Behavioral: Beating the Blues
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2015)
20
Original Enrollment  ICMJE
 (submitted: September 14, 2005)
500
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 81 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00209170
Other Study ID Numbers  ICMJE IRB00001092
R01MH069254-03 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dominique Musselman, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Dominique L Musselman, MD, MS Emory University
PRS Account Emory University
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP