Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)
2022年2月2日 更新者：Organon and Co
Long-term Study of Asenapine in Subjects With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (Protocol P06238)
This is a multi-site, open-label fixed-flexible dose long-term study of asenapine in participants with schizophrenia.
Participants in this study consist of schizophrenia with residual subtype or receiving high dose/multiple antipsychotic drugs, treatment refractory, or elderly participants with schizophrenia.
The treatment period is up to 52 weeks.
調査の概要
研究の種類
介入
入学 (実際)
157
段階
- フェーズ 3
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
20年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Minimum age of 20 years
Participants who meet at least one of the following:
- current diagnosis of schizophrenia of residual subtype
- received treatment with 3 or more antipsychotic drugs
- treatment-refractory participants with schizophrenia
- 65 years old and over with positive schizophrenia symptoms with score of 3 (mild) or more in 1 or more items in the positive subscale of the Positive and Negative Syndrome Scale (PANSS) at the baseline
- Participants who have a Clinical Global Impressions-Severity (CGI-S) score of at least 4 (moderately ill) at the baseline
Exclusion Criteria:
- Uncontrolled, unstable clinically significant medical condition
- Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings at Screening
- Positive pregnancy test at Screening, or the intention to become pregnant during the course of the study
- Seizure disorder beyond childhood (12 years old or younger)
- History of neuroleptic malignant syndrome
- Allergy or sensitivity to drugs such as psychotropics and antipsychotics
- Known history of or currently treated for narrow angle glaucoma
- Parkinson's disease
- Diagnosis of schizoaffective disorder; schizophreniform disorder
- Concurrent psychiatric disorder other than schizophrenia coded on Axis I; a primary diagnosis other than schizophrenia
- Diagnosis of borderline personality disorder
- Diagnosis of mental retardation or organic brain disorder
- Current (past 6 months) substance abuse or dependence according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (excluding nicotine)
- Positive drug/alcohol tests at the Screening visit
- Imminent risk of self-harm or harm to others, in the Investigator's opinion
- Substance induced psychotic disorder or a behavioral disturbance thought to be due to substance abuse
- Currently under involuntary inpatient confinement
- Use of a non-approved drug in Japan within 12 weeks prior to informed consent
- Previously treated in an asenapine study
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
|---|---|
|
実験的：Asenapine
Asenapine 5 mg twice daily (BID) for the first week of treatment, then either 5 mg or 10 mg BID.
|
5 mg or 10 mg fast-dissolving sublingual tablets BID for up to 52 weeks
|
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 |
|---|---|---|
|
錐体外路症状のある参加者の数
時間枠：治験薬最終投与後30日以内（最長約56週間）
|
この測定は、錐体外路症状を表すと定義された有害事象グループのいずれかを経験した参加者の総数を報告します。
少なくとも 1 人の参加者に発生した用語について、この定義内の個々の有害事象が発生した参加者の数も表示されます。
この措置では、規制活動用医学辞書 (MedDRA) 標準 MedDRA クエリ (SMQ) 内の「錐体外路症候群」に関するすべての有害事象用語が錐体外路症状として扱われました。
|
治験薬最終投与後30日以内（最長約56週間）
|
|
Change From Baseline in Weight at Week 52
時間枠：Baseline and Week 52
|
For each participant, change from baseline in weight was calculated as the Week 52 value minus the baseline value.
|
Baseline and Week 52
|
|
Change From Baseline in BMI at Week 52
時間枠：Baseline and Week 52
|
For each participant, change from baseline in BMI was calculated as the Week 52 value minus the baseline value.
|
Baseline and Week 52
|
|
Change From Baseline in HbA1c at Week 52
時間枠：Baseline and Week 52
|
Blood samples for determination of HbA1c were obtained at baseline and during the study.
For each participant, change from baseline in HbA1c at Week 52 was calculated as the Week 52 value minus the baseline value.
|
Baseline and Week 52
|
|
Change From Baseline in Fasting Glucose at Week 52
時間枠：Baseline and Week 52
|
Blood samples for determination of fasting glucose level were obtained at baseline and during the study.
For each participant, change from baseline in fasting glucose at Week 52 was calculated as the Week 52 level minus the baseline level.
|
Baseline and Week 52
|
|
Change From Baseline in Insulin at Week 52
時間枠：Baseline and Week 52
|
Blood samples for determination of insulin level were obtained at baseline and during the study.
For each participant, change from baseline in insulin at Week 52 was calculated as the Week 52 level minus the baseline level.
|
Baseline and Week 52
|
|
Change From Baseline in Prolactin at Week 52
時間枠：Baseline and Week 52
|
Blood samples for determination of prolactin level were obtained at baseline and during the study.
For each participant, change from baseline in prolactin at Week 52 was calculated as the Week 52 level minus the baseline level.
|
Baseline and Week 52
|
|
Change From Baseline in PANSS Total Score at Week 52
時間枠：Baseline and Week 52
|
The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia.
It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items).
Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions).
Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal).
For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme.
The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms.
The reported measure is the change from baseline at Week 52 (calculated for a participant as Week 52 value minus baseline value); improvement in symptoms is represented by negative values.
|
Baseline and Week 52
|
|
Change From Baseline in PANSS Total Score at Final Assessment
時間枠：Baseline up to Week 52
|
The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia.
It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items).
Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions).
Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal).
For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme.
The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms.
The reported measure is the change from baseline at the final assessment for a participant (calculated for a participant as final assessment value minus baseline value); improvement in symptoms is represented by negative values.
|
Baseline up to Week 52
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2011年4月5日
一次修了 (実際)
2014年8月21日
研究の完了 (実際)
2014年8月21日
試験登録日
最初に提出
2010年11月18日
QC基準を満たした最初の提出物
2010年11月18日
最初の投稿 (見積もり)
2010年11月19日
学習記録の更新
投稿された最後の更新 (実際)
2022年2月4日
QC基準を満たした最後の更新が送信されました
2022年2月2日
最終確認日
2022年2月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- P06238
- 132325 (レジストリ識別子：Japic-CTI)
- MK-8274-042 (その他の識別子：Merck protocol number)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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。