Side Effects of Newer Antipsychotics in Older Adults
キーワード
概要
説明
Atypical antipsychotic medications introduced within the last decade have been used increasingly for the treatment of several types of psychotic disorders and severe behavioral disturbances in older individuals. This trend is primarily due to a decrease in side effects caused by the new medications, as compared to conventional neuroleptic medications. There is a lower risk for developing tardive dyskinesia and extrapyramidal symptoms, both of which are movement abnormalities, with new antipsychotic medications. However, there has been a growing concern that the newer medications can cause a different set of potentially serious adverse side effects. Specifically, they may cause long-term metabolic, cardiovascular, and cerebrovascular effects, which may result in weight gain, diabetes, or stroke. This study will compare four atypical antipsychotic medications in terms of the risk of metabolic, cardiovascular, and cerebrovascular side effects that each presents in middle-aged and elderly individuals.
Participants in this open-label study will be randomly assigned to receive one of three atypical antipsychotic medications: aripiprazole; olanzapine; or risperidone. Although assignment is random, a technique that may reflect the participant's own interests or the researcher's knowledge of relevant participant characteristics will be used to assign the participant to a medication. Dosing will be determined by each participant's psychiatrist. Participants will be followed for up to 5 years to assess the side effects of the study medications, with study visits at baseline, Week 6, and every 3 months thereafter.
日付
| 最終確認済み: | 11/30/2018 |
| 最初に提出された: | 10/24/2005 |
| 提出された推定登録数: | 10/24/2005 |
| 最初の投稿: | 10/26/2005 |
| 最終更新が送信されました: | 12/12/2018 |
| 最終更新日: | 12/16/2018 |
| 実際の研究開始日: | 07/31/2005 |
| 一次完了予定日: | 09/30/2010 |
| 研究完了予定日: | 09/30/2010 |
状態または病気
介入/治療
Drug: 3: Aripiprazole
Drug: 4: Olanzapine
Drug: 1: Risperdal
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: 1: Risperdal Participants randomized to this arm will be prescribed risperdal. They will continue to be followed by their psychiatrist. In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff. | Drug: 1: Risperdal Participant will take risperidone. Dosing will be determined by each participant's psychiatrist. |
| Experimental: 3: Aripiprazole Participants randomized to this arm will be prescribed aripiprazole. They will continue to be followed by their psychiatrist. In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff. | Drug: 3: Aripiprazole Participant will take aripiprazole. Dosing will be determined by each participant's psychiatrist. |
| Experimental: 4: Olanzapine Participants randomized to this arm will be prescribed olanzapine. They will continue to be followed by their psychiatrist. In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff. | Drug: 4: Olanzapine Participant will take olanzapine. Dosing will be determined by each participant's psychiatrist. |
適格基準
| 研究の対象となる年齢 | 40 Years に 40 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: - DSM-IV diagnosis of a disease or disorder that requires treatment with an atypical antipsychotic medication Exclusion Criteria: - N/A |
結果
主な結果の測定
1. Change in Body Mass Index [Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96]
2. Change in Fasting Plasma Glucose (FPG) [Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96]
3. Change in LDL cholesterol, HDL cholesterol, and triglycerides [Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96]
