Randomized Double Blind Placebo Control Study in Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Psychosis Not Otherwise Specified; Schizophreniform Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Ondansetron; Simvastatin; Placebo; Odansetron plus simvastatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ondansetron added to TAU Ondansetron will be administered in 8mg once daily dose; Simvastatin added to TAU Simvastatin 20mg taken as once daily dose; Placebo added to TAU; Ondansetron will be administered in 8mg once daily dose and Simvastatin 20mg taken as once daily dose
Intervention MeSH terms: Ondansetron; Simvastatin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anti inflammatory; Schizophrenia; Simvastatin; Ondansetron