Double Blind, Placebo-Controlled, Randomised Investigation of Ondansetron in Schizophrenia
Condition: Schizoaffective and Schizophreniform Disorders; Schizophrenia
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Ondansetron; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 8mg per day oral capsule; daily oral capsule matched to active study medication. Made form 100% lactose powder
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment