Trial | NCT01602029  Report issue

Title

Randomized Double Blind Placebo Control Study in Patients With Schizophrenia
Randomized Double Blind Placebo Controlled Study of Ondansetron and Simvastatis Added to Treatment as Usual in Patients With Schizophrenia

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    simvastatin ondansetron ...

  • Study Participants

    303
Negative symptoms and cognitive deficits are two partially-related features of schizophrenia which have a major negative impact on social function and objective quality of life. Standard drug treatments have little impact on either and arguably no effect on primary negative symptoms. Social dysfunction has major economic consequences in both the developed and developing world. There is evidence that anti-inflammatory treatment may have beneficial effects in patients with schizophrenia.
Negative symptoms and cognitive deficits are two partially-related features of schizophrenia which have a major negative impact on social function and objective quality of life. Evidence indicates that anti-inflammatory treatment may have beneficial effects in schizophrenia. From our preliminary randomised double-blind placebo-controlled clinical trial in Pakistan and Brazil, it is indicated that addition of minocycline (an antibiotic and anti-inflammatory drug) for one year to treatment as usual (TAU) reduced negative symptoms and improved some cognitive measures (Chaudhry et al 2009).

Statins are primarily HMG-CoA reductase inhibitors also anti-inflammatory agents and known to decrease C-reactive protein (CRP). Higher levels of CRP (>0.50 mg/dl) are associated with marked negative symptoms and higher total PANSS scores in patients with schizophrenia. (Fan et al 2007)

Ondansetron, a selective 5-hydroxytryptamine-3 antagonist, is quite commonly used as an antiemetic in cancer patients (Marty et al 1990). There are several small trials suggesting that ondansetron as an adjunct to antipsychotics is effective in improving negative symptoms and memory in patients suffering from schizophrenia (Ahkonzadeh et al 2009, Levkovitz et al 2005 and Zhang et al 2006).

The Primary objective of this study is addition of ondansetron and /or simvastatin to TAU for patients with schizophrenia will result in improvement in negative symptoms

The Secondary objectives include:

improvement in positive or other symptoms
social functioning
cognitive functions
additive effects of ondansetron and simvastatin
Study Started
Aug 31
2010
Primary Completion
Jun 30
2013
Study Completion
Jun 30
2013
Last Update
Nov 11
2014
Estimate

Drug Ondansetron

ondansetron added to TAU Ondansetron will be administered in 8mg once daily dose

Drug Simvastatin

Simvastatin added to TAU Simvastatin 20mg taken as once daily dose

Drug Placebo

Placebo added to TAU

Drug Odansetron plus simvastatin

Ondansetron will be administered in 8mg once daily dose and Simvastatin 20mg taken as once daily dose

Ondansetron Active Comparator

ondansetron added to TAU Ondansetron will be administered in 8mg once daily dose

Simvastatin Active Comparator

Simvastatin added to TAU Simvastatin 20mg taken as once daily dose

Placebo Placebo Comparator

Placebo added to TAU

Odansetron Plus Simvastatin Active Comparator

Ondansetron will be administered in 8mg once daily dose and Simvastatin 20mg taken as once daily dose

Criteria 

Inclusion Criteria

Patients aged 18 to 65 years
Patients will be recruited both from inpatients and outpatients.
Diagnostic and Statistical Manual-IV (DSM-IV TR) diagnosis of schizophrenia, schizoaffective disorder, psychosis not otherwise specified or schizophreniform disorder
Competent and willing to give informed consent
Stable on medication 4 weeks prior to baseline
No planned medication change
Able to take oral medication and likely to complete the required evaluations
Female participants of child bearing age must be willing to use adequate contraceptives for the duration of the study, and, willing to have a pregnancy test pre treatment and at ten weekly intervals while on study medication,
Not planning to relocate in the next 12 months

Exclusion Criteria

Relevant ICD 10 organic brain disease or neurological diagnoses (including ECG conduction abnormalities, neurological disorder, or an active seizure)
Subjects who will meet the criteria for a DSM-IV TR diagnosis of alcohol or substance abuse (other than for nicotine) within the last month or the criteria for DSM-IV TR alcohol or substance dependence (other than for nicotine) within the last 6 months
Any change of psychotropic medications within the previous 4 weeks
Pregnant or lactating women and those of reproductive age without adequate contraception
No Results Posted