Trial Outcomes & Findings for Effectiveness of Tropisetron Plus Risperidone for Improving Cognitive and Perceptual Disturbances in Schizophrenia (NCT NCT00435370)

NCT ID: NCT00435370

Last Updated: 2017-03-15

Results Overview

The following 8 scales are combined into a single index that is normalized with a mean score of 100 and a standard deviation of 10. Higher scores are considered better cognitive performance. No subscales scores are reported and a final standardized score is reported as the average of the standardized scores on each of these scales. Here is the listing of component scales that were translated into Chinese and used for this study: Brief Assessment of Cognition in Schizophrenia (BACS): Symbol-Coding Trail Making Test: Part A Attention/Vigilance Continuous Performance Test-Identical Pairs (CPT-IP)\* Wechsler Memory Scale®-3rd Ed. (WMS®-III): Spatial Span + Letter-Number Span Hopkins Verbal Learning Test-Revised™ (HVLT-R™) Brief Visuospatial Memory Test-Revised (BVMT-R™) Neuropsychological Assessment Battery® (NAB®): Mazes Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT™):

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 179 participants
• Primary outcome timeframe: end of 12 wk treatment
• Results posted on: 2017-03-15

Participant Flow

The recruitment period began in May 2006 and ended in April 2011. Participants were approached for participation in this study after being hospitalized for at least 2 weeks if they were schizophrenic and capable of providing written informed consent.

After signing informed consent for participation in the study, subjects were interviewed by study doctor and all medical and psychiatric data were reviewed prior to admitting the subject and beginning medication.

Participant milestones

Measure	Tropisetron Tropisetron (10mg/day) + risperidone(6mg/day)	Placebo Placebo + risperidone (6mg/day)
Overall Study STARTED	90	89
Overall Study COMPLETED	68	69
Overall Study NOT COMPLETED	22	20

Reasons for withdrawal

Measure	Tropisetron Tropisetron (10mg/day) + risperidone(6mg/day)	Placebo Placebo + risperidone (6mg/day)
Overall Study Adverse Event	8	8
Overall Study Withdrawal by Subject	10	10
Overall Study Antipsychotic medication changed	4	2

Baseline Characteristics

Effectiveness of Tropisetron Plus Risperidone for Improving Cognitive and Perceptual Disturbances in Schizophrenia

Baseline characteristics by cohort

Measure	Tropisetron n=90 Participants Tropisetron (10mg/day) + risperidone(6mg/day)	Placebo n=89 Participants Placebo + risperidone (6mg/day)	Total n=179 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	90 Participants n=5 Participants	89 Participants n=7 Participants	179 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28.8 years STANDARD_DEVIATION 9.2 • n=5 Participants	28.3 years STANDARD_DEVIATION 9.9 • n=7 Participants	28.6 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	50 Participants n=7 Participants	102 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	39 Participants n=7 Participants	77 Participants n=5 Participants
Region of Enrollment China	90 participants n=5 Participants	89 participants n=7 Participants	179 participants n=5 Participants

PRIMARY outcome

Timeframe: end of 12 wk treatment

The following 8 scales are combined into a single index that is normalized with a mean score of 100 and a standard deviation of 10. Higher scores are considered better cognitive performance. No subscales scores are reported and a final standardized score is reported as the average of the standardized scores on each of these scales. Here is the listing of component scales that were translated into Chinese and used for this study:

Brief Assessment of Cognition in Schizophrenia (BACS): Symbol-Coding Trail Making Test: Part A Attention/Vigilance Continuous Performance Test-Identical Pairs (CPT-IP)* Wechsler Memory Scale®-3rd Ed. (WMS®-III): Spatial Span + Letter-Number Span Hopkins Verbal Learning Test-Revised™ (HVLT-R™) Brief Visuospatial Memory Test-Revised (BVMT-R™) Neuropsychological Assessment Battery® (NAB®): Mazes

Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT™):

Outcome measures

Measure	Tropisetron n=90 Participants Tropisetron (10mg/day) + risperidone(6mg/day)	Placebo n=89 Participants Placebo + risperidone (6mg/day)
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Domains	96 units on a scale Standard Deviation 16	95 units on a scale Standard Deviation 15

Adverse Events

Tropisetron

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tropisetron n=90 participants at risk Tropisetron (10mg/day) + risperidone(6mg/day)	Placebo n=89 participants at risk Placebo + risperidone (6mg/day)
General disorders Other Adverse Event	8.9% 8/90 • Number of events 8 • 6 months	6.7% 6/89 • Number of events 6 • 6 months

Additional Information

Dr. Thomas R. Kosten

Baylor College of Medicine

Phone: (713) 794-7032

Email: kosten@bcm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place