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Depression-Diabetes Mechanisms: Urban African Americans

27 juillet 2015 mis à jour par: Dominique Musselman, Emory University
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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

20

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Georgia
      • Atlanta, Georgia, États-Unis, 30303
        • Grady Hospital Diabetes Clinic

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 81 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Beating the Blues is a computerized cognitive behavioral therapy.
Escitalopram is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It's a 10 mg pill taken once or twice daily for 6 months.
Autres noms:
  • Lexapro
Comparateur actif: 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
Beating the Blues is a computerized cognitive behavioral therapy.
A sugar pill taken as one to two tablets daily for 6 months.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week 24
Délai: 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

Baseline, week 24

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Dominique L Musselman, MD, MS, Emory University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mai 2004

Achèvement primaire (Réel)

1 mai 2008

Achèvement de l'étude (Réel)

1 mai 2008

Dates d'inscription aux études

Première soumission

14 septembre 2005

Première soumission répondant aux critères de contrôle qualité

14 septembre 2005

Première publication (Estimation)

21 septembre 2005

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

29 juillet 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 juillet 2015

Dernière vérification

1 juillet 2015

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Beating the Blues

3
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