Depression- Diabetes Mechanisms: Urban African Americans

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00209170
First received: September 14, 2005
Last updated: May 8, 2008
Last verified: May 2008
  Purpose

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). Our 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.


Condition Intervention Phase
Diabetes
Depression
Behavioral: Cognitive Behavior Therapy
Drug: Lexapro
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Depression- Diabetes Mechanisms: Urban African Americans

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Glycemic control: Assessed as levels of HbA1c:
  • Neurometabolic Variables: The impact of treatment on changes in HPA axis activation, sympathomedullary and other counter-regulatory hormones, immunoinflammatory factors, and insulin resistance.
  • Adherence: The maintenance of scheduled appointments will be measured both by patients who keep their one-year appointments or not, and among those who return at one year, the percentage of interim appointments kept.
  • Variability in followup: Since it is likely that some patients will not return for all scheduled follow-up appointments, we will compare characteristics of patients who dropped out vs. those who did not in the escitalopram and placebo groups.

Secondary Outcome Measures:
  • We will also compare changes in HbA1c and adherence in the two treatment arms (n=250 each) with the two groups from Aim #1 - depressed patients given "usual care" (n=500) and nondepressed patients (n=3000).

Estimated Enrollment: 500
Study Start Date: May 2004
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

To determine the psychobehavioral and neurohormonal mechanisms of effective treatment, we 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. We will assess (a) glycemic control (levels of 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.

After completion of 6 months, patients may enter an open-label treatment with escitalopram or be tapered off their study medication. If patients develop worsening depressed mood, at any time during the study they will be offered treatment with open-label escitalopram or an alternative antidepressant for the remainder of the 52 weeks of the study.

  Eligibility

Ages Eligible for Study:   18 Years to 81 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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 OR ANY OF THE MEDS BELOW during in the last 2 weeks (8 weeks for fluoxetine)

    1-(Aminomethyl)cyclohexaneacetic acid 5-Hydroxytryptamine Alprazolam Amitriptyline-doses greater than 50 mg/day Amoxapine-doses greater than 50 mg/day Aripiprazole Atomoxetine Beconase Benadryl Benztropine mesylate Bupropion Carbamazepine Citalopram Clozapine Coumadin Desipramine-doses greater than 50 mg/day Dextroamphetamine Escitalopram Felbamate Fluoxetine Flurazepam Guanethidine Guanethidine Haloperidol Hydrocortisone Imipramine-doses greater than 50 mg/day Isosorbide dinitrate Kava kava Lamotrigine Lithium Lorazepam Maprotiline-doses greater than 50 mg/day Methyldopa Methylphenidate Mifepristone Mirtazapine Modafinil Nefazodone Nitroglycerin Nitroprusside Nortriptyline-doses greater than 50 mg/day Olanzapine Paroxetine Pemoline Phenelzine Phenylephrine Phenylpropanolamine Pramipexole Prednisone Reserpine Risperidone S-adenosyl-methionine (SAME) Sinequan-doses greater than 50 mg/day St. John's Wort Tempazepam Testosterone injections or patches Tetrahydrozoline Theophylline Tranylcypromine Trazodone Valerian Root Valproic acid Warfarin Zalpelon Ziprasidone Zonisamide Zolpidem

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209170

Locations
United States, Georgia
Grady Hospital Diabetes Clinic
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Forest Laboratories
Investigators
Principal Investigator: Dominique L Musselman, MD, MS Emory University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00209170     History of Changes
Other Study ID Numbers: R01 MH069254-03, R01 MH069254-03
Study First Received: September 14, 2005
Last Updated: May 8, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Diabetes Mellitus
Behavioral Symptoms
Mood Disorders
Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Citalopram
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014