Schizophrenia Clinical Trial
Official title:
Double Blind, Placebo-Controlled, Randomised Investigation of Ondansetron in Schizophrenia
NCT number | NCT01121042 |
Other study ID # | 145/10 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | July 2010 |
Est. completion date | August 2018 |
Verified date | October 2020 |
Source | Bayside Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 85 |
Est. completion date | August 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Aged between 18-65 years of age 2. Have a current DSM-IV-TR diagnosis of schizophrenia, schizoaffective of schizophreniform disorders (diagnosis will be confirmed using the MINI Neuropsychiatric Interview) 3. Have been treated with a stable and standard dose (as determined by the PORT Treatment Recommendations for schizophrenia [33]) of an atypical antipsychotic agent (not including amisulpride owing to its 5HT3 actions) as their primary antipsychotic treatment for a minimum of eight weeks before entry into the trial 4. Are experiencing positive symptoms as evidenced by a score of >15 on the Positive Syndrome Subscale of the PANSS, and/or negative psychotic symptoms as evidenced by a score of >15 on the Negative Syndrome Subscale of the PANSS and /or significant cognitive dysfunction, as evidenced by at least 15 on the cognitive subscale. The cognition subscale used in this study, which included items of G10, G11, G12, P2, N5, and N7 from the PANSS were generated from previous studies. 5. Have a level of understanding sufficient to provide informed consent and to communicate with the investigators, study coordinator, and site personnel. Exclusion Criteria: 1. Have an unstable medical condition, neurological disorder or an unstable seizure disorder. Any clinical significant electrocardiogram (ECG) abnormality at screening, including sinus bradycardia (ersting heart rate <50 beats per minute), atrial fibrillation, 2nd or 3rd degree AV block (AVB), prolonged ATc (QTcF>450ms in males or >470ms in females) history of congenital long AT syndromes, or risk of Torsades de Pointes because of family history of sudden death. 2. Currently pregnant or breastfeeding 3. Have a current DSM-IV-TR diagnosis of substance abuse or dependence disorder, or another Axis I disorder 4. Regularly use of another 5HT3 antagonist such as metoclopramide, cocaine, tropisetron, granisetron, palonosetron |
Country | Name | City | State |
---|---|---|---|
Australia | Monash Alfred Psychiatry Research Centre (MAPrc) | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
Bayside Health |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive and Negative Symptom Scale (PANSS) | 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. | At screening visit and at three monitoring visits (week 4, week 8, week 12) | |
Secondary | The Montgomery Åsberg Depression Rating Scale (MADRS) | 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. | At baseline visit and at three monitoring visits (week 4, week 8, week 12) | |
Secondary | Blood Test= C-Reactive Protein (CRP) | CRP to determine changes in baseline levels in systemic and central nervous system inflammation) | Screening visit and monitoring visit (week 12) |
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