A Multicenter, Placebo-controlled, Double-blind Investigative Extension Trial of the Safety and Efficacy of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
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:
- Trial subjects will be men and women of age 18 or above and below the age of 65 who will not be turning 65 during the trial.
- Subjects have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial.
- Subjects who meet DSM-IV-TR criteria for manic or mixed episodes and have been diagnosed as having "296.4x Bipolar I Disorder in which the most recent episode was manic" or "296.6x Bipolar I Disorder in which the most recent episode was mixed"
- Subjects who were enrolled in and have completed Study 003 and who meet the following criteria for demonstration of drug efficacy
Subjects demonstrating drug efficacy:
- Those subjects who completed Study 003 whose score for CGI-BP Change From Preceding Phase (mania) at the time of evaluation on Day 21 of Study 003 (completion) was between 1 (Very much improved) and 3 (Minimally improved)
Exclusion Criteria:
Subjects presenting with a clinical picture and/or history that is consistent with a DSM-IV-TR diagnosis of:
- Delirium, dementia, amnestic disorder, or other cognitive disorders
- Schizophrenia or other psychotic disorder
- Personality disorder
- Subjects with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance
- Subjects who represent a significant risk of committing suicide
- Subjects known to have a complication of allergy to aripiprazole or other quinolinone-skeleton compounds
- Subjects with a complication of neuroleptic malignant syndrome
- Subjects in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition
- Subjects with a complication of paralytic ileus
- Subjects with a complication of organic brain disorder or convulsive disorder, such as epilepsy
- Subjects with a complication of diabetes
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：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：1
|
経口 24mg(4錠)/日
他の名前：
|
|
プラセボコンパレーター：2
|
経口 0mg(4錠)/日
他の名前：
|
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 |
|---|---|---|
|
Young Mania Rating Scale (YMRS)
時間枠：Baseline (Day 1 of preceding study) , Day 154 or at discontinuation
|
Using LOCF datasets, descriptive statistics of actual values for changes of YMRS total scores from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated for each treatment group. YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) levated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior. YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome). |
Baseline (Day 1 of preceding study) , Day 154 or at discontinuation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)
時間枠：Baseline (Day 1 of preceding study), Day 154 or at discontinuation
|
Using LOCF datasets, descriptive statistics of actual values for change of CGI-BP severity of illness score (mania) from baseline (Day 1 of preceding study) to endpoint (Day 154) were calculated for each treatment group. CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components-mania, depression, and overall bipolar illness. CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill). |
Baseline (Day 1 of preceding study), Day 154 or at discontinuation
|
協力者と研究者
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
- 031-06-004
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。
双極Ⅰ型障害の臨床試験
-
University of NebraskaBristol-Myers Squibb利用できない
-
University Hospital, Basel, Switzerland完了