The Metabolic Effects of Antidepressants in Patients Diagnosed With Major Depressive Disorder
Objective There is growing evidence showing a relation between depression, metabolic syndrome, diabetes, cardiovascular disease (1), serum lipid profile (2,3) and body weight (4), as well as the effects of some of the antidepressant medications on these various conditions and profiles.
The aim of the study is to examine the influence of antidepressant medications on the metabolic profiles (5) of patients suffering from Major Depressive Disorder (MDD).
Group of patients:
30 Patients aged 18-65, who were diagnosed with MDD according to the DSM-IV criteria.
Research Design and Methods:
Research duration will be 8 weeks. Patients meeting the inclusion criteria will be recruited after being diagnosed with MDD and having undertaken the HDRS. A follow-up HDRS will be taken at weeks 4 and 8. The psychiatric evaluation will be held by a resident in psychiatry.
The following metabolic parameters will be examined at base-line and at the end of the 8 weeks:
Weight, height, waist circumference, body mass index (BMI: (Weight in Kg/(Height in meters)2), sitting blood pressure (after 3 minutes of sitting).
Serum lipid profile (performed in Ziv hospital's chemistry lab): Low density lipoprotein cholesterol, High density Lipoprotein cholesterol, Triglycerides, Total cholesterol, Apolipoprotein level (Apo AI, Apo B, Apo E, Apo AII).
Fasting glucose and insulin blood levels, in order to evaluate insulin-release and resistance, according to the following formulas:
Insulin Resistance:
HOMA IR=Fasting glucose (mg/dL)x Fasting insulin (mmol/L)/405
Insulin Release:
HOMA-β={360xfasting insulin (mmol/L)}/{glucose(mg/dL)-63} Serum oxidative stress parameters according to the F2-Isoprostane kit will be measured.
Malonylaialdehyde (MDA) content in serum will be analyzed by the thiobarbituric acid reactive substances assay, which measures malondialdehyde equivalent (13). Conjugated dienes will be measured at 234nm (14, 15).
調査の概要
状態
条件
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Osamah Hussein, MD
- メール:osama.h@ziv.health.gov.il
研究場所
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Safed、イスラエル、13110
- 募集
- Ziv MC
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主任研究者:
- Osamah Hussein, MD
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コンタクト:
- Osamah Hussein, MD
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- MDD diagnosed patients with a Hamilton Depression Rating Scale (HDRS) score of at least 18 points. Patients not treated with medications or such that had shown resistance to treatment, and were therefore assigned for drug replacement.
- Patients on stable therapy for hypertension, diabetes mellitus, hypothyroidism, dyslipidemia and / or weight lowering medications
Exclusion Criteria:
- Patients receiving antipsychotic treatment as well as patients on mood stabilizers will be excluded.
- Patients with uncontrolled diabetes mellitus, uncontrolled thyroid functioning, or uncontrolled hypertension, as well as patients who regularly consume alcohol will be excluded.
- Patients with uncontrolled malignancy are excluded as well.
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
コホートと介入
グループ/コホート |
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30 Patients with MDD.
30 Patients aged 18-65, who were diagnosed with MDD according to the DSM-IV criteria.
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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 |
時間枠 |
---|---|
the influence of antidepressant medications on the metabolic profiles (5) of patients suffering from Major Depressive Disorder.
時間枠:8 WEEKS
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8 WEEKS
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Osamah Hussein, MD、ZIV Medical Center
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
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
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