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

NCT01516424 | Completed Phase 3 Results DMC

• 1 other identifier: D4906011
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Schizophrenia

Keywords

Blonanserin

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8

  Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 8 at the end of treatment. PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. It have 30 evaluation items, which include 7 positive sub-scale, 7 negative sub-scale and 16 general psychopathology sub-scale on a score of 1 to 7. The total score is the sum of the 30 scale items. The minimum score is 30 and the maximum score is 210. Patient with PANSS total scores\<70 is the normal,but the scores\>120 is more serious.Change=(Week 8 Score - Baseline score)

  From baseline to the end of study、week 8(day 56)or before other antipsychotic taken.

Secondary Outcomes (4)

• Mean Change in PANSS Subscale Score at the End of Treatment

  week 8

• Mean Change in PANSS 5-factor Model

  Week 8

• Mean Change in PANSS Symptom Scores

  Week 8

• Mean Change in PANSS Symptom Scores From Baseline at Each Visit

  Each Visit

Study Arms (2)

Blonanserin

EXPERIMENTAL

Antipsychotics

Drug: Blonanserin

Risperidone

ACTIVE COMPARATOR

Antipsychotics

Drug: Risperidone

Interventions

Blonanserin DRUG

Blonanserin tablets: 8 - 24mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days.

Also known as: Lonasen

Blonanserin

Risperidone DRUG

Risperidone tablets: 2 - 6mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days.

Also known as: Risperdal

Risperidone

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sumitomo Pharma (Suzhou) Co., Ltd.: lead

Study Sites (16)

Beijing Anding Hospital

Beijing, Beijing Municipality, 100088, China

Location

Beijing Huilongguan Hospital

Beijing, Beijing Municipality, 100096, China

Location

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100191, China

Location

Guangzhou Brain Hospital

Guangzhou, Guangdong, 510170, China

Location

Hebei Province Mental Health Center

Baoding, Hebei, 071000, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

Henan Provincial Mental Hospital

Xinxiang, Henan, 453002, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

Hunan Province Brain Hospital

Changsha, Hunan, 410007, China

Location

Nanjing Brain Hospital

Nanjing, Jiangsu, 210029, China

Location

Wuxi Mental Health Center

Wuxi, Jiangsu, 214000, China

Location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Xi'an Mental Health Center

Xi’an, Shanxi, 710061, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, 300222, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

blonanserin; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr.HuafangLi
• Organization: Shang Hai Mental health center

lhlh_5@163.com

13641625395

Study Officials

• Niufan Gu, MD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: January 18, 2012
• First Posted: January 24, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: November 27, 2018
• Results First Posted: November 26, 2018

Record last verified: 2018-05

Locations

CN (16)