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Randomized, double-blind, placebo-controlled add-on trial of the safety and efficacy of R1678 in outpatients on select atypical antipsychotics with prominent negative or disorganized thought symptoms

Randomized, double-blind, placebo-controlled add-on trial of the safety and efficacy of R1678 in outpatients on select atypical antipsychotics with prominent negative or disorganized thought symptoms

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220620
Enrollment
Unknown
Registered
2008-10-10
Start date
2008-10-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

investigational material(s) Generic name etc : R1678 INN of investigational material : Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational material : Pat

Sponsors

Chugai Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -diagnosis of schizophrenia (based on screening tests); -outpatients, with no hospitalization for worsening of schizophrenia within 3 months; -medically and psychiatrically stable over prior 1 month; -currently taking no more than 2 antipsychotic drugs.

Exclusion criteria

Exclusion criteria: -began a new non-medication treatment for schizophrenia or other psychiatric condition within last 3 months; -on >1 antidepressant, or a change in dose of antidepressant within 3 months; -alcohol or substance abuse or dependence within 3 months; -has previously received R1678

Design outcomes

Primary

MeasureTime frame
Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score. Time frame: Week 8—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026