Trial Outcomes & Findings for Efficiency Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone (NCT NCT01516424)

Last Updated: 2018-11-27

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

267 participants

Primary outcome timeframe

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

Results posted on

2018-11-27

Participant Flow

Participant milestones

Participant milestones
Measure	Blonanserin Blonanserin: Dosage Form: Tablet Dosage and Usage: 8\~24mg/d ,b.i.d	Risperidone Risperidone: Dosage Form: Tablet Dosage and Usage: 2\~6mg/d ,b.i.d
Overall Study STARTED	131	136
Overall Study COMPLETED	96	114
Overall Study NOT COMPLETED	35	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Blonanserin n=128 Participants Participants received 8-24mg tablet orally twice daily for 8 weeks	Risperidone n=133 Participants Participants received 2-6mg tablet orally twice daily for 8 weeks	Total n=261 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	128 Participants n=5 Participants	133 Participants n=7 Participants	261 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	58 Participants n=7 Participants	128 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	75 Participants n=7 Participants	133 Participants n=5 Participants

PRIMARY outcome

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

Population: 267 subjects in participant flow, 3 subjects randomized and not treated, 2 subjects does not have baseline PANSS scale, 1 subject take Blonanserin, which randomized to Risperidone group and no PANSS scale collected after first dose. Those 6 subjects excluded from Baseline Population. The Baseline population have 261 subjects.

Outcome measures

Outcome measures
Measure	Blonanserin n=128 Participants Participants received 8-24mg tablet orally twice daily for 8 weeks.	Risperidone n=133 Participants Participants received 2-6mg tablet orally twice daily for 8 weeks.
Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8 ITT analysis: At the end of treatment	-30.59 score on a scale Standard Error 18.53	-33.56 score on a scale Standard Error 16.89
Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8 PPS analysis: At the end of treatment	-33.71 score on a scale Standard Error 17.02	-36.31 score on a scale Standard Error 14.09

SECONDARY outcome

Timeframe: week 8

Other events: 122 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Blonanserin n=130 participants at risk Participants received 8-24mg tablet orally twice daily for 8 weeks	Risperidone n=134 participants at risk Participants received 2-6mg tablet orally twice daily for 8 weeks
Skin and subcutaneous tissue disorders chicken pox	0.77% 1/130 • Number of events 1 Safety analysis set (SS, the primary analysis set for safety evaluation) SS of this study included all randomized subjects who have received at least 1 dose of the trial drug. The SS population have 130 subjects in Blonanserin group, 134 subjects in Risperidone group.	0.00% 0/134 Safety analysis set (SS, the primary analysis set for safety evaluation) SS of this study included all randomized subjects who have received at least 1 dose of the trial drug. The SS population have 130 subjects in Blonanserin group, 134 subjects in Risperidone group.
Renal and urinary disorders Urinary retention	0.00% 0/130 Safety analysis set (SS, the primary analysis set for safety evaluation) SS of this study included all randomized subjects who have received at least 1 dose of the trial drug. The SS population have 130 subjects in Blonanserin group, 134 subjects in Risperidone group.	0.75% 1/134 • Number of events 1 Safety analysis set (SS, the primary analysis set for safety evaluation) SS of this study included all randomized subjects who have received at least 1 dose of the trial drug. The SS population have 130 subjects in Blonanserin group, 134 subjects in Risperidone group.
Gastrointestinal disorders Gastrointestinal foreign matter	0.00% 0/130 Safety analysis set (SS, the primary analysis set for safety evaluation) SS of this study included all randomized subjects who have received at least 1 dose of the trial drug. The SS population have 130 subjects in Blonanserin group, 134 subjects in Risperidone group.	0.75% 1/134 • Number of events 1 Safety analysis set (SS, the primary analysis set for safety evaluation) SS of this study included all randomized subjects who have received at least 1 dose of the trial drug. The SS population have 130 subjects in Blonanserin group, 134 subjects in Risperidone group.
Respiratory, thoracic and mediastinal disorders fever of unknown origin	0.00% 0/130 Safety analysis set (SS, the primary analysis set for safety evaluation) SS of this study included all randomized subjects who have received at least 1 dose of the trial drug. The SS population have 130 subjects in Blonanserin group, 134 subjects in Risperidone group.	0.75% 1/134 • Number of events 1 Safety analysis set (SS, the primary analysis set for safety evaluation) SS of this study included all randomized subjects who have received at least 1 dose of the trial drug. The SS population have 130 subjects in Blonanserin group, 134 subjects in Risperidone group.

Other adverse events

Additional Information

Dr.HuafangLi

Shang Hai Mental health center

Phone: 13641625395

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place