Health Condition 1: F20- Schizophrenia
Conditions
Interventions
Intervention1: Adjunctive Ondansetron Therapy: Tablet Ondansetron 8mg BD orally for 6 weeks in patients with schizophrenia along with usual treatment
Control Intervention1: Placebo: Tablet Placebo BD
Sponsors
Central Institute of Psychiatry
Eligibility
Inclusion criteria
Inclusion criteria: 1.Inpatients satisfying the ICD 10-DCR [1993] criteria for schizophrenia 2.Current positive symptoms rated >=4 (moderate) on one or more of these BPRS items: conceptual disorganization, grandiosity, hallucinatory behaviour and unusual thought content. 3.Age 18 - 60 years of both sexes. 4.Illness duration of equal to or more than 2 years. 5.Those who give informed consent for participating in the study
Exclusion criteria
Exclusion criteria: 1.Any other major co-morbid psychiatric diagnosis and substance dependence excluding nicotine & caffeine. 2.Known hypersensitivity to Tab. Ondansetron or any of its components. 3.Receiving concomitant Apomorphine. 4.Deranged liver function test (Alanine transaminase >= 180 IU/l and/or Aspartate transaminase >= 140 IU/l). 5.Significant current/past medical or neurological illness including severe hepatic disease and history of severe head injury. 6.Patients who received ECT in the last 6 months or currently receiving ECT. 7.QTc interval >= 450ms in males and >= 470ms in females on Electrocardiogram (ECG). 8.Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of T. Ondansetron (16mg/day) as an adjunctive therapy assessed by PANSS and CGI-SCH scores in patients with schizophrenia.Timepoint: Baseline, 2 weeks and 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in cognitive symptoms as assessed by CANTAB in patients receiving adjunctive T. Ondansetron (16mg/day)Timepoint: Baseline and 6 weeks | — |
Countries
India
Contacts
Public ContactDr Roshan V Khanande
Central Institute of Psychiatry
Outcome results
None listed