Schizophrenia Clinical Trial
Official title:
Tropisetron With Risperidone for Schizophrenia
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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