問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberP06124
NCT Number(ClinicalTrials.gov Identfier)NCT01098110

2010-09-01 - 2012-12-31

Phase III

Terminated13

ICD-10F20.9

Schizophrenia, unspecified

A multicenter, randomized, double-blind, fixed-dose, 6-week trial of the efficacy and safety of asenapine compared with placebo in subjects with an acute exacerbation of schizophrenia (Phase 3 ; Protocol No. P06124)

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

    MSD K.K.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 林式穀 Division of Psychiatry
Taipei City Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ya-Mei Bai Division of Psychiatry
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator ChingYen Chen Division of Psychiatry
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 謝明鴻 Division of Psychiatry
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 廖定烈 Division of Psychiatry
Psychiatric Center,MOHW

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 陳震宇 Division of Psychiatry
Taipei Veterans Center Hospital Yuli Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 林清華 Division of Psychiatry
Kaohsiung Municipal Kai-Syuan Psychiatric Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 歐陽文貞 Division of Psychiatry
Jianan Psychiatric Center,MOHW

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator NAN-YING CHIU Division of Psychiatry
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 吳百堅 Division of General Internal Medicine
Yuli Hospital Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 黃三原 Division of Psychiatry
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 唐子俊 Division of Psychiatry
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Tzung-Jeng Hwang Division of Psychiatry
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

13 Terminated

Condition/Disease

Schizophrenia

Objectives

The main goal of this trial is to evaluate the changes in the total score of PANSS compared to the baseline to evaluate the twice-daily (BID) asenapine 5 mg and 10 mg treatments, compared to placebo, for the test for acute attacks of schizophrenia The effect of the author. Secondary test objectives: -Assess the efficacy of asenapine 5 and 10 mg BID in the treatment of schizophrenia on the PANSS subscale compared with placebo (positive symptoms, negative symptoms, and general psychopathology). -To evaluate the effect of asenapine on Marder's factor in the treatment of schizophrenia (positive symptoms, negative symptoms, confusion, hostility/agitation, and anxiety/depression) -Evaluate the effect of asenapine on important safety parameters, including weight gain, BMI, EPS, HbA1c, fasting blood glucose, insulin and prolactin Other goals: -Assess safety and tolerability, -Check the minimum blood glucose concentration of asenapine and its main metabolite N-desmethylasenapine when stable.

Test Drug

Asenapine (SCH 900274)

Active Ingredient

Asenapine

Dosage Form

sublingual tablets

Dosage

5 mg, 10 mg

Endpoints

The main efficacy evaluation indicators of this trial are: the change in the total score of the Positive and Negative Syndrome Scale (PANSS) from the reference point to the 42nd day. The secondary efficacy evaluation indicators of this trial are: PANSS subscale scores, PANSS Marder factor scores from the baseline to the 42nd day, and based on PANSS, CGI-S (Clinical Overall Impression-Severity) and CGI-I on the 42nd day (Clinical overall impression-extent of improvement) Determine the number of subjects with curative effects.
The safety evaluation indicators of this test are: adverse events and physiological examinations, vital signs (blood pressure and pulse), weight and waist circumference, body mass index (BMI), electrocardiogram (ECG), laboratory parameters (blood, biochemical and urinalysis) ), HbA1c (glycated hemoglobin), fasting blood glucose, prolactin, drug-induced extrapyramidal symptom scale (Drug Induced Extrapyramidal Symptom Scale, DIEPSS) clinical significant changes, and whether to use anti-Parkinson's disease drugs.

Inclution Criteria


The subject must meet all of the following conditions:
1. The age of the subject is between 20-64 years old;
2. The subject is currently diagnosed with delusional (295.30), chaotic (295.10), catatonic (295.20), or unclassified (295.90) schizophrenia;
3. The total PANSS score of the subjects during the screening period and the reference point must be at least 60 points;
4. The experimenting physician confirmed that the subject had an acute exacerbation of schizophrenia;
5. The subject's clinical global impressions-severity (CGI-S) scale score at the baseline should reach at least 4 points (moderate disease).

Exclusion Criteria


The subject must meet all of the following conditions:
1. The subject's body mass index (BMI) at the reference point must not be <16.0 or >35.0;
2. The subject shall not be the type of treatment ineffectiveness defined by the following conditions: (1) Have received at least two different atypical antipsychotics, and the dose is equal to or higher than 600 mg of chlorpromazine (12 mg of haloperidol per day) ) For more than 4 weeks, but none of the drugs produced clinical treatment response, or (2) had received clozapine treatment for 12 weeks before screening;
3. Subjects must not receive more than 3 antipsychotics within one month before random assignment, or the equivalent dose must not exceed 18 mg of haloperidol per day (equivalent to 900 mg of chlorpromazine per day);
4. Subjects must not have received asenapine treatment before.

The Estimated Number of Participants

  • Taiwan

    180 participants

  • Global

    528 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB