A Phase 3 interventional study of Tropisetron and Placebo in Smoking Cessation and Schizophrenia, sponsored by Baylor College of Medicine. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2017-03-15.
Sponsored by Baylor College of Medicine · Phase 3, Interventional, and Treatment
This study will determine the effectiveness of tropisetron plus risperidone in improving cognitive symptoms in Chinese people with schizophrenia.
Schizophrenia is a chronic and disabling brain disorder. People with schizophrenia may experience hallucinations, delusions, disordered thinking, movement disorders, social withdrawal, and cognitive deficits. In considering the high rate of cigarette smoking among people with schizophrenia, it is also likely that they smoke. People with schizophrenia who smoke tend to experience improved cognition, and tobacco withdrawal has been associated with deterioration of cognition. This suggests that nicotine may improve cognitive deficits or medication side effects in people with schizophrenia.
Auditory sensory gating, a neural mechanism thought to reflect sensory information processing and affect cognition, is diminished in people with schizophrenia. Auditory sensory gating has been associated with the 7 nicotinic acetylcholine receptor, a brain receptor that is important for cognition and can be activated by nicotine. Activation of this receptor using an agonist medication, such as tropisetron, may produce the same positive effect that nicotine has on cognition. This study will determine the effectiveness of using tropisetron as supplemental therapy to the atypical neuroleptic risperidone in people with schizophrenia.
Participants in this 12-week double blind study will be randomly assigned to receive either tropisetron or placebo. All participants will also follow a 6-mg risperidone regimen. Study visits will occur every 2 weeks throughout the study and final outcome assessments will include cognitive functioning and treatment safety and effectiveness.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 179 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tropisetron (10mg/day) + risperidone(6mg/day)
Drug: Tropisetron · Drug: Risperidone
Placebo + risperidone (6mg/day)
Drug: Placebo · Drug: Risperidone
10 mg/day
Also known as: Navoban
placebo
6mg/day
Also known as: Risperdal, Ridal, Rispolept
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Domains
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™):
Time frame: end of 12 wk treatment
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.
| Milestone | Tropisetron | Placebo |
|---|---|---|
| Started | 90 | 89 |
| Completed | 68 | 69 |
| Not completed | 22 | 20 |
| Withdrew: Adverse event | 8 | 8 |
| Withdrew: Withdrawal by subject | 10 | 10 |
| Withdrew: Antipsychotic medication changed | 4 | 2 |
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™):
| units on a scale | Tropisetron | Placebo |
|---|---|---|
| Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Domains | 96 ± 16 | 95 ± 15 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tropisetron | — | 0/90 (0%) | 8/90 (8.9%) |
| Placebo | — | 0/89 (0%) | 6/89 (6.7%) |
| Event | Tropisetron | Placebo |
|---|---|---|
| Other Adverse EventGeneral disorders | 8/90 | 6/89 |
| Age, Categorical(Participants) | Tropisetron | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 90 | 89 | 179 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Tropisetron | Placebo | Total |
|---|---|---|---|
| Mean | 28.8 ± 9.2 | 28.3 ± 9.9 | 28.6 ± 9.6 |
| Sex: Female, Male(Participants) | Tropisetron | Placebo | Total |
|---|---|---|---|
| Female | 52 | 50 | 102 |
| Male | 38 | 39 | 77 |
| Region of Enrollment(participants) | Tropisetron | Placebo | Total |
|---|---|---|---|
| China | 90 | 89 | 179 |
Plan to share: No
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