A Long-term Trial of OPC-34712 in Patients With Schizophrenia

Phase 3CompletedNCT01456897

Otsuka Pharmaceutical Co., Ltd.282 enrolled

Overview

To investigate the safety and efficacy of long-term administration of OPC-34712 in patients with schizophrenia.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

282

Conditions

Schizophrenia

Interventions

OPC-34712DRUG

orally administered once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients age 18 years or older (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria * Outpatients who are receiving an oral antipsychotic treatment (other than clozapine), who are considered to require maintenance therapy using antipsychotics, and for whom monotherapy with OPC-34712 is considered feasible Exclusion Criteria: * Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product * 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)

Locations (1)

Unnamed facility

Kanto Region, Japan

Outcomes

Primary Outcomes

Percentage of Participants With Adverse Events

A treatment-emergent adverse event (TEAE) is defined as an AE that started after start of investigational medicinal product (IMP) treatment.

Time frame: From Baseline up to 52 Weeks

Secondary Outcomes

Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score

The PANSS consisted of 3 subscales with 30 symptom constructs (positive subscale (7): delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/perseckion, and hostility; negative subscale (7): blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and conversation flow, stereotyped thinking and general psychopathology subscale (16): somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Severity was rated on 7-point scale with scores 1 (absence) \& 7 (extremely severe). The PANSS Total score ranged from 7 (best possible outcome) to 210 (worst possible outcome).

Time frame: From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF)

Mean Change From Baseline in PANSS Positive Subscale Score

The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In PANSS positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).

Time frame: From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF)

Data from ClinicalTrials.gov

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