Phase 3 Completed N=267 Randomized Quadruple-blind Treatment

Efficiency Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone

Schizophrenia

Source: ClinicalTrials.gov NCT01516424 ↗

Enrolled (actual)

267

Serious AEs

1.5%

Results posted

Nov 2018

Primary outcomePrimary: Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8 — -30.59; -33.56; -33.71; -36.31 score on a scale — p=<0.05

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8	-30.59; -33.56; -33.71; -36.31	<0.05 sig
SECONDARY Mean Change in PANSS Subscale Score at the End of Treatment	—	—
SECONDARY Mean Change in PANSS 5-factor Model	—	—
SECONDARY Mean Change in PANSS Symptom Scores	—	—
SECONDARY Mean Change in PANSS Symptom Scores From Baseline at Each Visit	—	—

Eligibility Criteria

Inclusion Criteria

Subject met Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV-Text Revision(TR) criteria for a primary diagnosis of schizophrenia
Patients are 18≤age<65 years of age on the day when informed consent is obtained.
Subject had a PANSS total score ≥70 and 120≥ at Screening
Subject had a score ≥4 on the PANSS at Screening and Baseline.
Subjects are willing and able to comply with study protocol including treatment in hospital.
Subjects or their legal guardians have signed the written informed consent form.

Exclusion Criteria

The subject was treatment with other Investigate product within 30 days.
Subject had a history of treatment with long-acting drug for anti schizophrenia within 56 days.
Subject had a history of treatment with clozapine within 28 days.
Subject With parkinson disease,etc

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01516424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.