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Evaluation of ondanstrone effect in reduction of negative symptoms in inpatients with schizophrenia disorder

Evaluation of ondanstrone -as an adjuant- in reduction of negative symptoms in schizophrenic inpatients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014031211071N2
Enrollment
48
Registered
2014-04-23
Start date
2012-08-22
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: Intervention group:The usual daily dose atypical anti-psychotic plus 8 mg of ondansetron daily. Intervention 2: The usual daily dose atypical anti-psychotic plus Palacebo daily.
Treatment - Drugs
Intervention group:The usual daily dose atypical anti-psychotic plus 8 mg of ondansetron daily.
The usual daily dose atypical anti-psychotic plus Palacebo daily

Sponsors

Ahvaz Jundishapur University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: a diagnosis of schizophrenia according to DSM-IV-TR; an overall score of 50 or higher on the PANSS scale; 15 or higher negative score in PANSS scale; duration of at least 1 year from onset of the illness. Exclusion criteria: history of sensitivity to ondanstrone; serious medical illness; substance abuse or dependency in recent months; pregnancy; lactation; other simultaneous psychiatric disorders requiring medication; desire to homicide or suicide; having dementia and severe cognitive impairments not bound to schizophrenia; organic brain disorders such as seizure; severe mental retardation and Parkinsonism; consumption of oral antipsychotics during last month or long-acting Injectable forms within three months; Concomitant use of other drugs such as antidepressants; lithium which may interfere in treatment; drug-resistant schizophrenia disorder; lack of response to appropriate dosage and duration of Risperidone.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Negative sign. Timepoint: at the end of weeks 0 ,3 and 6. Method of measurement: PANSS questionnaire.

Secondary

MeasureTime frame
Positive sign. Timepoint: at the end of weeks 0 ,3 and 6. Method of measurement: PANSS questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMousa Samadi

Jundishapur University of Medical Sciences

Mousasamadi58@yahoo.com+98 61 1374 3038

Outcome results

None listed

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