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Tropisetron plus standard care versus placebo to improvement of cognitive impairment for people with schizophrenia: a randomized controlled trial

Tropisetron plus standard care versus placebo to improvement of cognitive impairment for people with schizophrenia: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022365
Enrollment
Unknown
Registered
2019-04-08
Start date
2019-04-30
Completion date
Unknown
Last updated
2019-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

schizophrenia

Interventions

experimental group:Tropisetron combined with Risperidone
Placebo control:Placebo combined with Risperidone

Sponsors

Beijing An'ding Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: (1) outpatient or inpatient patients, aged 18-55 years, gender not limited, junior high school education or above; (2) meet the DSM-IV diagnostic criteria for schizophrenia, with the total course of illness less than or equal to 5 years; (3) risperidone monotherapy is more than or equal to 1 month, and the stable dose is less than or equal to 6mg/d; (4) at least two MCCB tests were found to have cognitive deficits of more than 1.5 standard deviations; (5) non-smokers; (6) normal hearing, no previous hearing system disease; (7) families and patients sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) comorbidity with other mental disorders, severe physical diseases such as metabolism, heart, liver, kidney and nervous system; (2) had a history of alcohol or drug abuse in the past 12 months and dependence in the past 6 months; (3) received MECT within 6 months; (4) people who are known to be allergic to tropisetron; (5) pregnant or lactating women and women of childbearing age who do not intend to use contraception; (6) it is necessary to drive or operate machinery during the test.

Design outcomes

Primary

MeasureTime frame
MATRICS Consensus Cognitive Battery;prepulse inhibition;

Secondary

MeasureTime frame
Positive and Negative Syndrome Scale;SANS;

Countries

China

Contacts

Public ContactQijing Bo
bqj718@163.com+86 18810956956

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026