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

NCT01451164 | Completed Phase 2 Results

• 2 other identifiers: 331-10-002JapicCTI-111631
• Study Type: interventional
• Target: 459
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients with schizophrenia.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score

  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).

  Baseline, Weeks 1, 2, 3, 4, 5, and 6

Secondary Outcomes (4)

• Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.

  Baseline, Weeks 1, 2, 3, 4, 5, and 6

• Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.

  Baseline, Weeks 1, 2, 3, 4, 5, and 6

• Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness (CGI-S)

  Baseline, Weeks 1, 2, 3, 4, 5, and 6

• Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.

  Baseline, Weeks 1, 2, 3, 4, 5, and 6

Study Arms (4)

High dose

EXPERIMENTAL

Drug: OPC-34712

Mid dose

EXPERIMENTAL

Drug: OPC-34712

Low dose

EXPERIMENTAL

Drug: OPC-34712

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

OPC-34712 DRUG

orally administered once daily

High dose

Placebo DRUG

orally administered once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Kanto Region, Japan

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., Ltd.

CL_OPCJ_RDA_Team@otsuka.jp

Study Officials

• kyoji Imaoka, Operating Officer

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 13, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2015
• Last Updated: October 3, 2019
• Results First Posted: October 3, 2019

Record last verified: 2016-10

Locations

JP (1)