Double Blind, Placebo-Controlled, Randomised Investigation of Ondansetron in Schizophrenia
Schizoaffective and Schizophreniform Disorders
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Double Blind, Placebo-Controlled, Randomised Investigation of Ondansetron in Schizophrenia|
- Positive and Negative Symptom Scale (PANSS) [ Time Frame: At screening visit and at three monitoring visits (week 4, week 8, week 12) ] [ Designated as safety issue: No ]The PANSS is a widely used, drug-sensitive, valid and reliable measure of psychopathology in schizophrenia. The PANSS is a formal interview, from which 30 symptoms are rated along a 7 point scale that ranges from 1 (absent) to 7 (extreme psychopathology). Schizophrenia symptom severity will be assessed with the PANSS and monitored to determine change in total, positive, negative, cognitive or general psychopathology symptoms.
- The Montgomery Åsberg Depression Rating Scale (MADRS) [ Time Frame: At baseline visit and at three monitoring visits (week 4, week 8, week 12) ] [ Designated as safety issue: No ]The MADRS is a 10 item semi-structured clinician-rated interview of depression where each item (depression symptom) is rated of a 7 point scale ranging from 0 to 6. The MADRS will be used to monitor the participant's experience of depressive symptoms and severity across the trial.
- Blood Test= C-Reactive Protein (CRP) [ Time Frame: Screening visit and monitoring visit (week 12) ] [ Designated as safety issue: No ]CRP to determine changes in baseline levels in systemic and central nervous system inflammation)
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Ondansetron
Ondansetron oral capsule 8mg daily
8mg per day oral capsule
Placebo Comparator: Placebo
Placebo (100% lactose) matched oral capsule
daily oral capsule matched to active study medication. Made form 100% lactose powder
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121042
|Contact: Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD||+61 3 9076 email@example.com|
|Contact: Anthony deCastella, Dip App Sci, BA, MA||+61 3 9076 6554 ext firstname.lastname@example.org|
|Monash Alfred Psychiatry Research Centre (MAPrc)||Recruiting|
|Melbourne, Victoria, Australia, 3004|
|Contact: Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD +61 3 9076 6924 email@example.com|
|Contact: Anthony deCastella, Dip AppSci,BA,MA +61 3 9076 6554 firstname.lastname@example.org|
|Principal Investigator: Professor Jayashri Kulkarni|
|Principal Investigator:||Professor Jayashri Kulkarni||Monash Alfred Psychiatry Research Centre (MAPrc)|