Role of Anti-Inflammatory Agents in Patients With Schizophrenia
Recruitment status was: Recruiting
There is some evidence that anti-inflammatory treatment may have beneficial effects in schizophrenia and major depression. Cox-2 inhibitors have been tested in preliminary clinical trials for schizophrenia and depression, showing favourable effects compared to placebo (Muller and Schwarz et al 2009).
Statins were introduced as cholesterol-lowering agents but have found much wider usage. They are anti-inflammatory agents and thus similar to the Cox-2 inhibitors, which have shown some ability as adjuncts to improve the symptoms of schizophrenia in preliminary studies. The statins are also known to decrease C-reactive protein (CRP), which has been shown in an SMRI-funded study to be elevated in a study of individuals with schizophrenia. Fan et al (2007) demonstrated in a small study in patients with schizophrenia that higher than normal levels of CRP (>0.50 mg/dl) was associated with marked negative symptoms and higher total PANSS scores.
Ondansetron is a serotonin (5-HT3) receptor antagonist that is generic and widely used to prevent nausea and vomiting in patients receiving chemotherapy for cancer. GSK did a small study on it as an antipsychotic in the 1980s. Since then, several small studies have suggested that it is effective as an adjunct drug in improving the symptoms of schizophrenia.
Statins are widely used in schizophrenia sufferers, particularly those taking second generation antipsychotics, to treat hypercholesterolemia. Both drugs are well tolerated and their side effect profiles well understood.
We propose to conduct a feasibility study in patients with chronic schizophrenia to explore the adjunct use of simvastatin and ondansetron on positive, negative and general psychopathology in comparisons to treatment as usual (TAU) over a 12 week period.
|Schizophrenia Schizoaffective Disorder Psychosis Not Otherwise Specified Schizophreniform Disorder||Drug: Ondansetron Drug: Simvastatin Drug: Placebo||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Study of Role of Anti-Inflammatory Agents in Patients With Schizophrenia|
- acceptability and tolerability of simvastatin and ondansetron added to TAU [ Time Frame: 3 months ]
- simvastatin and ondansetron added to TAU prevents the accumulation of negative symptoms in patients with schizophrenia [ Time Frame: 3 months ]
- simvastatin and ondansetron added to TAU prevents cognitive decline [ Time Frame: 3 months ]
- To compare the effect size [ Time Frame: 3 months ]
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||September 2009|
|Estimated Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: Ondansetron||
ondansetron added to TAU Ondansetron will be administered in 8mg once daily dose
|Active Comparator: Simvastatin||
Simvastatin added to TAU Simvastatin 20mg taken as once daily dose
|Placebo Comparator: Placebo||
Placebo added to TAU
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929955
|Contact: Imran B Chaudhry, MDfirstname.lastname@example.org|
|Contact: Nusrat Husain, MDemail@example.com|
|Dow University of Health Sciences||Recruiting|
|Contact: Raza ur Rahman +923002579364 firstname.lastname@example.org|
|Karwan e hayat||Recruiting|
|Contact: Ajmal Kazmi, MRCPsych +923213783890 email@example.com|
|Principal Investigator:||Imran B Chaudhry, MD||University of Manchester|