- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01451164
A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia
September 11, 2019 updated by: Otsuka Pharmaceutical Co., Ltd.
To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients with schizophrenia.
Study Overview
Study Type
Interventional
Enrollment (Actual)
459
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kanto Region, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients age 18 years or older to less than 65 years (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria
- Patients who are hospitalized, or judged to required hospitalization, for acute relapse of schizophrenia at time of informed consent
- Patients who are experiencing acute exacerbation of psychotic symptoms
Exclusion Criteria:
- Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
- Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator
- Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: Placebo
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orally administered once daily
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EXPERIMENTAL: High dose
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orally administered once daily
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EXPERIMENTAL: Mid dose
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orally administered once daily
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EXPERIMENTAL: Low dose
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orally administered once daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
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The PANSS consisted of three subscales: a total of 30 symptom constructs.
For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms).
The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel.
The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
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Baseline, Weeks 1, 2, 3, 4, 5, and 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.
Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
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PANSS consisted of three subscales: a total of 30 symptom constructs.
For each construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms).
The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel.
The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness, and hostility.
The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).
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Baseline, Weeks 1, 2, 3, 4, 5, and 6
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Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.
Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
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The PANSS consisted of three subscales: a total of 30 symptom constructs.
For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms).
The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel.
The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking.
The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).
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Baseline, Weeks 1, 2, 3, 4, 5, and 6
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Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness (CGI-S)
Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
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Severity of illness for each participant was rated using the CGI-S, which was the secondary efficacy endpoint.
To perform this assessment, the study physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant 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; and 7 = among the most extremely ill participants.
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Baseline, Weeks 1, 2, 3, 4, 5, and 6
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Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.
Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6
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The efficacy of trial medication was rated for each participant using the CGI-I.
The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment.
All responses were compared to the participant's condition at Baseline prior to the first dose of double-blind study medication.
Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
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Baseline, Weeks 1, 2, 3, 4, 5, and 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (ACTUAL)
June 1, 2015
Study Registration Dates
First Submitted
October 11, 2011
First Submitted That Met QC Criteria
October 11, 2011
First Posted (ESTIMATE)
October 13, 2011
Study Record Updates
Last Update Posted (ACTUAL)
October 3, 2019
Last Update Submitted That Met QC Criteria
September 11, 2019
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 331-10-002
- JapicCTI-111631 (OTHER: JAPIC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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