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The Efficacy of ondansetron augmentation in negative sign of Schizophrenia

The Efficacy of ondansetron augmentation in negative sign of Schizophrenia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201112125280N7
Enrollment
44
Registered
2012-04-17
Start date
2011-03-21
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

schizophrenia. Schizophrenia

Interventions

Intervention 1: Patients are required to have treated with a stable dose of risperidone (4-6mg/day) as their primary antipsychotic treatment and receive ondansetron (4-8 mg/day) for a minimum period
Treatment - Drugs
Placebo
Patients are required to have treated with a stable dose of risperidone (4-6mg/day) as their primary antipsychotic treatment and receive ondansetron (4-8 mg/day) for a minimum period of 8 weeks.
The control group receive the placebo in addition to risperidone (4-6 mg/day).

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients who have been treated with a stable dose of risperidone as their primary antipsychotic treatment for a minimum period of 8 weeks before entry into the study. Exclusion criteria: Patients who had any medical diagnoses (including ECG conduction abnormalities, neurological disorder, or an active seizure) or were receiving medications that may have affected cognitive performance; Subjects who met the criteria for a DSM IV diagnosis of alcohol or substance abuse (other than for nicotine) within the last month or the criteria for DSM-IV alcohol or substance dependence (other than for nicotine) within the last 6 months; Pregnant or lactating women and those of reproductive age without adequate contraception; psychotropic medications were not allowed for the duration of the study: anticholinergics, sedating antihistaminic, antidepressants, mood stabilizers, or a second antipsychotic (as adjuvant therapy).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Negative symptom. Timepoint: base line,weeks 4,8. Method of measurement: PANSS.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Soozan Soluti

Ibn-e-sina Hospital, Mashhad University of Medical Sciences

solutis881@mums.ac.ir+98 51 1879 7671

Outcome results

None listed

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