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

• Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01516424
• Collaborator: (none)
• Enrollment: 267
• Locations: 16
• Arms: 2
• Duration (Months): 12
• Patients Per Site: 16.7
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Blonanserin; Drug: Risperidone	Phase 3

Detailed Description

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

Trial drugs:

• Blonanserin group: Blonanserin tablets+Risperidone mimetic tablets

• Risperidone group: Risperidone tablets+Blonanserin mimetic tablets

Objectives of Study :

To evaluate the efficacy and safety of Blonanserin in treating schizophrenia

Study Design

• Study Type: Interventional
• Actual Enrollment: 267 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Blonanserin Antipsychotics	Drug: Blonanserin; 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.; Other Names: Lonasen
Active Comparator: Risperidone Antipsychotics	Drug: Risperidone; 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.; Other Names: Risperdal

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8 [From baseline to the end of study、week 8(day 56)or before other antipsychotic taken.]

   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)

Secondary Outcome Measures

1. Mean Change in PANSS Subscale Score at the End of Treatment [week 8]

   Mean Change in PANSS subscale score at the end of treatment at 8 weeks the frame of 8 weeks is from baseline

2. Mean Change in PANSS 5-factor Model [Week 8]

   Mean change in PANSS 5-factor model from baseline at Week 8

3. Mean Change in PANSS Symptom Scores [Week 8]

   Mean change in PANSS symptom scores from baseline at Week 8

4. Mean Change in PANSS Symptom Scores From Baseline at Each Visit [Each Visit]

   Mean change in PANSS symptom scores from baseline at each Visit from baseline at week 8

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Anding Hospital	Beijing	Beijing	China	100088
2	Beijing Huilongguan Hospital	Beijing	Beijing	China	100096
3	Peking University Sixth Hospital	Beijing	Beijing	China	100191
4	Guangzhou Brain Hospital	Guangzhou	Guangdong	China	510170
5	Hebei Province Mental Health Center	Baoding	Hebei	China	071000
6	The First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150001
7	Henan Provincial Mental Hospital	Xinxiang	Henan	China	453002
8	The Second Xiangya Hospital of Central South University	Changsha	Hunan	China	410000
9	Hunan Province Brain Hospital	Changsha	Hunan	China	410007
10	Nanjing Brain Hospital	Nanjing	Jiangsu	China	210029
11	Wuxi Mental Health Center	Wuxi	Jiangsu	China	214000
12	Shanghai Mental Health Center	Shang Hai	Shanghai	China	200030
13	Xi'an Mental Health Center	Xi'an	Shanxi	China	710061
14	West China Hospital, Sichuan University	Chengdu	Sichuan	China	610041
15	Tianjin Anding Hospital	Tianjin	Tianjin	China	300222
16	First Affiliated Hospital of Kunming Medical University	Kun Ming	Yunnan	China	650032

Sponsors and Collaborators

• Sumitomo Pharma (Suzhou) Co., Ltd.

Investigators

• Principal Investigator: Niufan Gu, MD, Shanghai Mental Health Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sumitomo Pharma (Suzhou) Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01516424
• Other Study ID Numbers: D4906011
• First Posted: Jan 24, 2012
• Last Update Posted: Nov 27, 2018
• Last Verified: May 1, 2018

• Keywords provided by Sumitomo Pharma (Suzhou) Co., Ltd.: Blonanserin
• Additional relevant MeSH terms: Schizophrenia; Risperidone

Study Results

Participant Flow

Arm/Group Title	Blonanserin	Risperidone
Arm/Group Description	Blonanserin: Dosage Form: Tablet Dosage and Usage: 8~24mg/d ,b.i.d	Risperidone: Dosage Form: Tablet Dosage and Usage: 2~6mg/d ,b.i.d
Period Title: Overall Study
STARTED	131	136
COMPLETED	96	114
NOT COMPLETED	35	22

Baseline Characteristics

Arm/Group Title	Blonanserin	Risperidone	Total
Arm/Group Description	Participants received 8-24mg tablet orally twice daily for 8 weeks	Participants received 2-6mg tablet orally twice daily for 8 weeks	Total of all reporting groups
Overall Participants	128	133	261
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	128 100%	133 100%	261 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	70 54.7%	58 43.6%	128 49%
Male	58 45.3%	75 56.4%	133 51%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8
Description	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)
Time Frame	From baseline to the end of study、week 8(day 56)or before other antipsychotic taken.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Blonanserin	Risperidone
Arm/Group Description	Participants received 8-24mg tablet orally twice daily for 8 weeks.	Participants received 2-6mg tablet orally twice daily for 8 weeks.
Measure Participants	128	133
ITT analysis: At the end of treatment	-30.59 (18.53)	-33.56 (16.89)
PPS analysis: At the end of treatment	-33.71 (17.02)	-36.31 (14.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Blonanserin, Risperidone
	Comments	ANCOVA was employed to compare the changes of PANSS scores at week 8 relative to the baseline in these 2 groups. Least Squares Means for the differences in changes between the 2 groups (μ blonanserin - μ risperidone) and the two-sided 95% Confidence Interval were calculated in accordance with the main model. H0: Compared with risperidone, blonanserin reduced more than 7.0 in mean change in PANSS total score from baseline at week 8 of treatment (μ blonanserin-μ risperidone> 7.0).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The power is 80%, non-inferiority margin is 7.0.
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	Satisfaction with the non-inferiority criteria was determined by the upper limit of confidence interval. If the upper limit of 95% confidence interval was less than 7.0, then non-inferiority was concluded.
	Method	ANCOVA
	Comments	Study center and grouping as fixed effects.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.69
	Confidence Interval	(2-Sided) 95%; -0.36 to 7.75
	Parameter Dispersion	Type: Value:
	Estimation Comments	This is ITT analysis data.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Blonanserin, Risperidone
	Comments	ANCOVA was employed to compare the changes of PANSS total scores at end of treatment relative to the baseline in these 2 groups. LSMeans for the differences in changes between the 2 groups (μ blonanserin - μ risperidone) and the two-sided 95% Confidence Interval were calculated in accordance with the main model. H0: Compared with risperidone, blonanserin reduced more than 7.0 in mean change in PANSS total score from baseline at week 8 of treatment (μ blonanserin-μ risperidone> 7.0).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The power is 80%, non-inferiority margin is 7.0.
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	Satisfaction with the non-inferiority criteria was determined by the upper limit of confidence interval. If the upper limit of 95% confidence interval was less than 7.0, then non-inferiority was concluded.
	Method	ANCOVA
	Comments	Study center and grouping as fixed effects.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.94
	Confidence Interval	(2-Sided) 95%; -0.76 to 6.65
	Parameter Dispersion	Type: Value:
	Estimation Comments	This is PPS analysis data.

2. Secondary Outcome

Title	Mean Change in PANSS Subscale Score at the End of Treatment
Description	Mean Change in PANSS subscale score at the end of treatment at 8 weeks the frame of 8 weeks is from baseline
Time Frame	week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Mean Change in PANSS 5-factor Model
Description	Mean change in PANSS 5-factor model from baseline at Week 8
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Mean Change in PANSS Symptom Scores
Description	Mean change in PANSS symptom scores from baseline at Week 8
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Mean Change in PANSS Symptom Scores From Baseline at Each Visit
Description	Mean change in PANSS symptom scores from baseline at each Visit from baseline at week 8
Time Frame	Each Visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Adverse Event Reporting Description	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.
Arm/Group Title	Blonanserin		Risperidone
Arm/Group Description	Participants received 8-24mg tablet orally twice daily for 8 weeks		Participants received 2-6mg tablet orally twice daily for 8 weeks
All Cause Mortality
	Blonanserin		Risperidone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Blonanserin		Risperidone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/130 (0.8%)		3/134 (2.2%)
Gastrointestinal disorders
Gastrointestinal foreign matter	0/130 (0%)	0	1/134 (0.7%)	1
Renal and urinary disorders
Urinary retention	0/130 (0%)	0	1/134 (0.7%)	1
Respiratory, thoracic and mediastinal disorders
fever of unknown origin	0/130 (0%)	0	1/134 (0.7%)	1
Skin and subcutaneous tissue disorders
chicken pox	1/130 (0.8%)	1	0/134 (0%)	0
Other (Not Including Serious) Adverse Events
	Blonanserin		Risperidone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	126/130 (96.9%)		122/134 (91%)
Cardiac disorders
Palpitations	8/130 (6.2%)	11	13/134 (9.7%)	15
Tachycardia	3/130 (2.3%)	4	5/134 (3.7%)	5
Sinus bradycardia	2/130 (1.5%)	2	5/134 (3.7%)	5
Sinus arrhythmia	2/130 (1.5%)	2	3/134 (2.2%)	3
Sinus tachycardia	2/130 (1.5%)	2	3/134 (2.2%)	4
Endocrine disorders
Galactorrhea	0/130 (0%)	0	3/134 (2.2%)	3
Eye disorders
Blurred vision	0/130 (0%)	0	3/134 (2.2%)	3
Gastrointestinal disorders
constipation	21/130 (16.2%)	28	22/134 (16.4%)	34
diarrhea	4/130 (3.1%)	5	4/134 (3%)	4
Nausea	3/130 (2.3%)	6	5/134 (3.7%)	5
Oropharyngeal pain	3/130 (2.3%)	3	4/134 (3%)	4
Toothache	2/130 (1.5%)	3	4/134 (3%)	5
Vomit	2/130 (1.5%)	2	3/134 (2.2%)	3
Hepatobiliary disorders
Abnormal liver function	9/130 (6.9%)	9	17/134 (12.7%)	17
Immune system disorders
Fatigue	3/130 (2.3%)	3	6/134 (4.5%)	7
sleepiness	4/130 (3.1%)	4	0/134 (0%)	4
Fever	0/130 (0%)	0	3/134 (2.2%)	3
Infections and infestations
Nasopharyngitis	14/130 (10.8%)	16	20/134 (14.9%)	23
Upperrespiratory tract infection	7/130 (5.4%)	8	4/134 (3%)	4
Tinea pedis	3/130 (2.3%)	3	0/134 (0%)	0
Investigations
Serum prolactin increase	68/130 (52.3%)	68	90/134 (67.2%)	90
Alanine aminotransferase increase	7/130 (5.4%)	7	8/134 (6%)	8
Aspartate aminotransferase increase	4/130 (3.1%)	4	5/134 (3.7%)	5
Blood triglycerides increase	3/130 (2.3%)	3	6/134 (4.5%)	6
Lipid increase	2/130 (1.5%)	2	5/134 (3.7%)	5
Body weight increase	2/130 (1.5%)	2	4/134 (3%)	4
Blood cholesterol increase	2/130 (1.5%)	2	3/134 (2.2%)	3
Transaminase increase	2/130 (1.5%)	2	3/134 (2.2%)	3
Blood potassium decrease	3/130 (2.3%)	3	1/134 (0.7%)	1
Metabolism and nutrition disorders
Poor appetite	4/130 (3.1%)	5	3/134 (2.2%)	3
Hyperlipidemina	3/130 (2.3%)	3	3/134 (2.2%)	3
Nervous system disorders
Extrapyramidal disorders	63/130 (48.5%)	71	39/134 (29.1%)	41
Dizziness	5/130 (3.8%)	7	6/134 (4.5%)	7
Tremor	3/130 (2.3%)	3	2/134 (1.5%)	2
Headache	3/130 (2.3%)	3	1/134 (0.7%)	1
Psychiatric disorders
Excitement	28/130 (21.5%)	32	16/134 (11.9%)	19
Insomnia	24/130 (18.5%)	31	18/134 (13.4%)	25
Anxiety	11/130 (8.5%)	11	11/134 (8.2%)	12
Poor sleep quality	6/130 (4.6%)	6	6/134 (4.5%)	6
Dysphoria	4/130 (3.1%)	4	2/134 (1.5%)	2
Somnipathy	3/130 (2.3%)	3	4/134 (3%)	4
Akathisia	4/130 (3.1%)	4	2/134 (1.5%)	2
Diffculty falling asleep	3/130 (2.3%)	4	3/134 (2.2%)	3
Irritability	4/130 (3.1%)	5	0/134 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	6/130 (4.6%)	6	2/134 (1.5%)	2
Stuffy nose	3/130 (2.3%)	3	2/134 (1.5%)	4
Expectoration	3/130 (2.3%)	3	1/134 (0.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.