Metabolic Signatures and Biomarkers in Schizophrenia
キーワード
概要
説明
Schizophrenia (SCH) is a devastating mental disease that affects the human population worldwide with an incidence of about 1%. Most individuals with this illness benefit from long-term pharmacotherapy, however, the therapeutic effects of antipsychotic treatment are inconsistent, incomplete, and often countered by significant side-effects associated with long-term physical morbidity (e.g., tardive dyskinesia, obesity, hyperglycemia, hyperlipidemia. Metabolomics is a powerful new technology that provides a snap shot of biochemical pathways at a particular point in time. It has been earmarked as an important area to develop under the NIH roadmap initiative. We plan to use this platform to map biochemical signatures in unmedicated schizophrenic patients prior to and 4 weeks post treatment with the antipsychotic drug aripiprazole and compare that to lipid perturbations induced by risperidone. These drugs have inherently different risk for metabolic adverse effects and patients respond to them differently. Metabolic signatures for the drugs capture significant biochemical information that could explain part of the basis for varied drug response within individuals and will highlight pathways implicated in drug action and in disease pathogenesis possibly enabling new drug design strategies.In addition, we will compare patients to healthy controls at baseline in regard lipid profiles, to assess whether lipid profiles differ between unmedicated schizophrenia patients and healthy controls.
日付
| 最終確認済み: | 02/28/2013 |
| 最初に提出された: | 04/24/2007 |
| 提出された推定登録数: | 04/24/2007 |
| 最初の投稿: | 04/26/2007 |
| 最終更新が送信されました: | 07/10/2014 |
| 最終更新日: | 07/24/2014 |
| 最初に提出された結果の日付: | 04/04/2011 |
| 最初に提出されたQC結果の日付: | 11/28/2012 |
| 最初に投稿された結果の日付: | 01/02/2013 |
| 実際の研究開始日: | 01/31/2007 |
| 一次完了予定日: | 12/31/2008 |
| 研究完了予定日: | 12/31/2010 |
状態または病気
介入/治療
Drug: Aripiprazole for 4 weeks
Drug: Risperidone for 4 weeks
Other: Healthy volunteers
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Active Comparator: Aripiprazole for 4 weeks Blood is drawn for baseline. 20 Subjects are randomly assigned to receive Aripiprazole for weeks weeks with a starting dose of 10mg/day and the dose will be titrated to a maximum of 30mg /day based on effectiveness and tolerability. After 4 weeks of treatment, blood will be drawn again for metabolomics. | Drug: Aripiprazole for 4 weeks Aripiprazole for 4 weeks |
| Active Comparator: Risperidone for 4 weeks Blood will be drawn for baseline evaluation. 20 Subjects will be randomly assigned to receive risperidone at a starting dose of 2mg/day, and can be increased to 6mg/day based on response of the subject. After 4 weeks of medication, blood is drawn again. | Drug: Risperidone for 4 weeks Subjects will be randomized to risperidone for 4 weeks |
| Other: Healthy volunteers Fasting blood samples will be drawn from healthy volunteers to match age, race and gender with the research subjects for comparison. | Other: Healthy volunteers Healthy volunteers |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - Age 18-60 years - Diagnosis of schizophrenia - Actively psychotic - No more than a single dose of antipsychotic in the preceding 2 weeks Exclusion Criteria: - Mental retardation, epilepsy or history of head trauma - Substance use disorder that explains the majority of the psychopathology - Pregnant or lactating females |
結果
主な結果の測定
1. Total Plasmalogen Levels in the Lipid Profile [Baseline]
