Oral Aripiprazole Open-Label Rollover Study
An Open- Label Rollover Study for Subjects With Schizophrenia Completing ABILIFY® (Aripiprazole) Clinical Study 31-03-241
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
研究場所
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Buenos Aires、アルゼンチン
- Study site
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Mendoza、アルゼンチン
- Study site
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Hyderabad、インド
- Study site
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Ludhiana、インド
- Study site
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Mumbai、インド
- Study site
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Tamilnadu、インド
- Study site
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Kharkiv、ウクライナ
- Study site
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Kiev、ウクライナ
- Study site
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Split、クロアチア
- Study site
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Belgrade、セルビア
- Study site
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Novi Sad、セルビア
- Study site
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Moscow、ロシア連邦
- Study site
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Rostov-on-Don、ロシア連邦
- Study site
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St.Petersburg、ロシア連邦
- Study site
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Yaroslavl、ロシア連邦
- Study site
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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
説明
Inclusion Criteria:
- Subjects with a confirmed Axis I Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia who must have completed Otsuka study 31-03-241 (NCT00102518) treatment of adolescent subjects with schizophrenia
Exclusion Criteria:
- Patients with a co-morbid serious, uncontrolled systemic illness
- Patients with a significant risk of committing suicide
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
- 介入モデル：並列代入
- 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：Oral Aripiprazole
Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
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Flexible dose between 5 mg and 30 mg Aripiprazole tablets.
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 |
メジャーの説明 |
時間枠 |
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths
時間枠：Up to 72 months
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An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject. Change in clinical relevance (severity increased) was entered as a new AE in the current trial. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (clinically significant) change from baseline for that individual subject. An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention. Additional information about Adverse Events can be found in the Adverse Event section. |
Up to 72 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change From Baseline in Clinical Global Impression Severity of Illness (CGI-S) Score
時間枠：Baseline, Last Visit (Up to 72 Months)
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The rater or investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Response choices included: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. A negative change from Baseline indicated improvement |
Baseline, Last Visit (Up to 72 Months)
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Number of Participants With Clinical Significant Laboratory Tests
時間枠：Baseline, Up to 72 Months
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Blood was collected for Fasting clinical laboratory tests (serum chemistry and hematology) at Baseline, Months 12, 24, 36, 48, 60, and 72 and were analyzed at a central laboratory. Clinically significant values are defined as the following: Bilirubin, total ≥ 2.0 mg/dL. Creatine phosphokinase > 500 U/L for participants 13-17 years or 3 times the upper limit of normal for participants ≥ 18 years [Reference Range (0 to 190 IU/L (females) and 0 to 235 IU/L (males)]. Eosinophils ≥ 10 %. Hematocrit < 30 % for participants 13-17 years old or ≥ 18 year old participants female ≤ 32 % and a 3 point decrease from baseline or male ≤ 37 % and a 3 point decrease from baseline. Hemoglobin female ≤ 9.5 g/dL or male ≤ 11.5 g/dL. Prolactin > 1 times the upper limit of normal [Reference range: 2 to 18 ng/mL (males) and 3 to 30 ng/mL (females)]. |
Baseline, Up to 72 Months
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Number of Participants With Clinically Significant Heart Rate
時間枠：Baseline, Up to 72 months
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Heart rate was measured at Baseline and at each visit supine (lying on the back) and standing.
A heart rate increase is an increase of ≥ 15 beats per minute (bpm) compared to Baseline.
A heart rate decrease is a decrease of ≥ 15 bpm compared to Baseline.
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Baseline, Up to 72 months
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Number of Participants With Clinically Significant Blood Pressure
時間枠：Baseline, Up to 72 months
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Systolic and Diastolic blood pressure was measured at Baseline and at all visits supine (lying on the back) and standing. Systolic increase was an increase of ≥ 20 mm Hg compared to Baseline and systolic decrease was a decrease of ≥ 20 mm Hg compared to Baseline. A diastolic increase was an increase of ≥ 15 mm Hg compared to Baseline and a diastolic decrease was a decrease of ≥ 15 mm Hg compared to Baseline. |
Baseline, Up to 72 months
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Number of Participants With Clinically Abnormal Changes in Electrocardiograms (ECGs) Evaluations
時間枠：Baseline, Up to 72 months
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A 12-lead ECG was recorded at Baseline, Months 6, 12, 24, 36, 48, 60 and 72. Three readings taken 5 minutes were read by a central ECG reading service and averaged. Clinically significant ECGs were defined as: Sinus Bradycardia: ≤ 50 beats per minute (bpm), decrease of ≥ 15 bpm from Baseline. Supraventricular premature beat: ≥ 2 per 10 seconds, increase from Baseline. Ventricular premature beat: ≥ 1 per 10 seconds, increase from Baseline. Right bundle branch block: present. Other intraventricular block: QRS ≥ 0.10 seconds for age 13-17 years or QRS ≥ 0.11 seconds for age ≥ 18 years, an increase of ≥ 0.02 seconds from Baseline. Symmetrical T-wave inversion: present. QTcB (QT interval corrected Bazett's formula), QTcF (QT interval corrected Fridericia's formula), QTcN (QT corrected FDA Neuropharmacology Division formula), QTcE (QT corrected fractional exponent correction method: ≥ 420 msec for age 13-17 years or ≥ 450 msec for age ≥ 18 years, ≥ 10 % increase from Baseline. |
Baseline, Up to 72 months
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Number of Participants Showing Significant Weight Gain or Loss
時間枠：Baseline, Up to 72 months
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Weight was measured at Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72.
A clinically significant weight gain was defined as a ≥ 7 % increase from Baseline.
A clinically significant Weight loss was defined as a ≥ 7% decrease from Baseline.
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Baseline, Up to 72 months
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Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
時間枠：Baseline, Up to 72 months
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The C-SSRS consisted of a baseline evaluation (completed at the first scheduled visit upon approval of protocol Amendment 3) that assessed the lifetime experience of the participant with suicide events and suicidal ideation and a post-baseline evaluation at each visit that focused on suicidality since the last trial visit.
Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity).
The number of participants experiencing suicidal ideation or suicidal behavior is reported.
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Baseline, Up to 72 months
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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
- 31-05-243
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