Schizophrenia Clinical Trial
Official title:
Double Blind, Placebo-Controlled, Randomised Investigation of Ondansetron in Schizophrenia
The aim of this study is to evaluate the overall effectiveness of Ondansetron as an adjunctive or "add-on" medication in the treatment of Schizophrenia. This study is a double blind, placebo-controlled, randomised, 12 week trial.
Ondansetron is a medication currently approved by the Australian Therapeutic Goods
Administration for the treatment of drug-induced vomiting and nausea. Beyond this traditional
use there have been several case reports and small clinical trials advocating the use of
Ondansetron in the treatment of adult Schizophrenia. Overall these studies lend support to
the use of Ondansetron in conjunction with mainstream antipsychotic medication in improving
not only the positive symptoms associated with Schizophrenia but also the 'hard to treat'
negative and cognitive symptoms. Furthermore, Ondansetron may also have potential benefits in
reducing the adverse motor effects (e.g. tremor, uncontrolled muscle movements) associated
with the use of many antipsychotic medications.
60 participants aged 18-65 inclusive with a DSM-IV diagnosis of Schizophrenia,
Schizoaffective, or Schizophreniform disorder will be recruited. This study proposes to
conduct a randomized, controlled treatment trial to investigate the efficacy of ondansetron
as an adjunctive treatment in reducing negative and positive symptoms plus improving
cognitive symptoms. There will be an initial screening session to determine participant
suitability, a baseline session where the study medication (Ondansetron or Placebo) will be
dispensed, followed by three monitoring visits.
The efficacy of Ondansetron will be evaluated by the following instruments:
- Positive and Negative Symptom Scale (PANSS)
- Montgomery-Åsberg Depression Rating Scale (MADRS)
- C-Reactive protein (marker of systematic and brain specific inflammation)
Safety will be assessed through adverse event reporting using the Adverse symptom Checklist
(ASC), blood analysis, urinalysis, a 12-lead Electrocardiogram (ECG) and a physical
examination. Adverse motor symptoms will also be assessed by the Abnormal Involuntary
Movement Scale and the Simpson-Angus Scale. In addition a safety and monitoring committee
consisting of research and medical staff external to the project will regularly review
adverse events.
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