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Depression-Diabetes Mechanisms: Urban African Americans

27 luglio 2015 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

20

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30303
        • Grady Hospital Diabetes Clinic

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 81 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altri nomi:
  • Lexapro
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week 24
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Dominique L Musselman, MD, MS, Emory University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2004

Completamento primario (Effettivo)

1 maggio 2008

Completamento dello studio (Effettivo)

1 maggio 2008

Date di iscrizione allo studio

Primo inviato

14 settembre 2005

Primo inviato che soddisfa i criteri di controllo qualità

14 settembre 2005

Primo Inserito (Stima)

21 settembre 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

29 luglio 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 luglio 2015

Ultimo verificato

1 luglio 2015

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Beating the Blues

3
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