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A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01451164
Recruitment Status : Completed
First Posted : October 13, 2011
Results First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE October 11, 2011
First Posted Date  ICMJE October 13, 2011
Results First Submitted Date  ICMJE September 11, 2019
Results First Posted Date  ICMJE October 3, 2019
Last Update Posted Date October 3, 2019
Study Start Date  ICMJE October 2011
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
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 ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 11, 2011)
PANSS Total Score
Change History Complete list of historical versions of study NCT01451164 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
  • Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score. [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6 ]
    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).
  • Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score. [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6 ]
    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).
  • 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 ]
    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.
  • Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6. [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2011)
CGI-S score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia
Official Title  ICMJE A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia
Brief Summary To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients with schizophrenia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: OPC-34712
    orally administered once daily
  • Drug: Placebo
    orally administered once daily
Study Arms  ICMJE
  • Experimental: High dose
    Intervention: Drug: OPC-34712
  • Experimental: Mid dose
    Intervention: Drug: OPC-34712
  • Experimental: Low dose
    Intervention: Drug: OPC-34712
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2019)
459
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01451164
Other Study ID Numbers  ICMJE 331-10-002
JapicCTI-111631 ( Other Identifier: JAPIC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otsuka Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Otsuka Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: kyoji Imaoka, Operating Officer Otsuka Pharmaceutical Co., Ltd.
PRS Account Otsuka Pharmaceutical Co., Ltd.
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP