Depression-Diabetes Mechanisms: Urban African Americans
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Georgia
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Atlanta、Georgia、アメリカ、30303
- Grady Hospital Diabetes Clinic
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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:
- 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
- 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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的: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.
他の名前:
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アクティブコンパレータ: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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week 24
時間枠:Baseline, week 24
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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
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Dominique L Musselman, MD, MS、Emory University
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB00001092
- R01MH069254-03 (米国 NIH グラント/契約)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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