Aripiprazole in Late Life Bipolar Disorder
調査の概要
詳細な説明
While medications such as valproate (Depakote and others) and lithium are generally considered first-line agents in late life bipolar disorder, side effects are common, and many individuals with bipolar disorder continue to have symptoms in spite of medication treatment. A continuing unmet need is the availability of medications that are generally well- tolerated and effective in later life bipolar disorders.
Antipsychotic medications such as Abilify are known to be effective for related conditions such as schizophrenia and are also used by some physicians in clinical settings in combination with mood stabilizing medications (Lithium, Depakote and others) to treat symptoms of bipolar disorder. Currently Abilify is approved by the FDA to treat schizophrenia and to treat bipolar disorder.
研究の種類
入学 (実際)
段階
- フェーズ 4
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:
- Must have Bipolar disorder as confirmed by the Mini Neuropsychiatric Interview (MINI)
- Must be age 50 or older
Must have sub-optimal response to current psychotropic management including at least one of the following:
- Behaviors and symptoms of irritability, agitation, mood liability or diminished ability to interact with others in their place of residence
- Diminished ability to take care of basic personal needs in their place of residence due to symptoms of bipolar disorder
- Intolerance to current psychotropic medications; and
- Must live in the Northeast Ohio area.
Exclusion Criteria:
- An unstable medical illness, or a medical illness, which in the opinion of the study investigators, is likely to affect the outcome of the study
- DSM-IV substance dependence (except nicotine or caffeine) within the past 3 months; or
- Receiving carbamazepine.
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：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：1
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Patients were continued on treatment with their existing mood stabilizing medication, and upon enrollment were initiated on aripiprazole augmentation treatment.
The initial starting dose of aripiprazole was 5 mg/day, with gradual upward titration as tolerated.
Initiation of new additional antipsychotic medications was not permitted during the course of the study, and antipsychotic medications prescribed at study start were tapered and discontinued by week 4 of the study if possible.
他の名前：
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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 |
|---|---|
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重さ
時間枠：12週間
|
12週間
|
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異常不随意運動尺度 (AIMS)
時間枠：12週間
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12週間
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クリニカル・グローバル・インプレッション (CGI)
時間枠：12週間
|
12週間
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Blood pressure and pulse
時間枠：12 weeks
|
12 weeks
|
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Barnes Akathisia Scale (BAS)
時間枠：12 weeks
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12 weeks
|
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Simpson Angus Neurological Rating Scale (SAS)
時間枠：12 weeks
|
12 weeks
|
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Basic serum chemistry - screening and 12/study end
時間枠：12 weeks
|
12 weeks
|
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Complete blood count (CBC) with differential - screening and 12/study end
時間枠：12 weeks
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12 weeks
|
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Electrocardiogram - screening and 12/study end
時間枠：12 weeks
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12 weeks
|
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Young Mania Rating Scale (YMRS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
時間枠：12 weeks
|
12 weeks
|
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Hamilton Depression Rating Scale (HAM-D) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
時間枠：12 weeks
|
12 weeks
|
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Global Assessment Scale (GAS)
時間枠：12 weeks
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12 weeks
|
協力者と研究者
出版物と役立つリンク
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
- 10864-01-L0363
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。