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Role of Anti-Inflammatory Agents in Patients With Schizophrenia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Pakistan Institute of Learning and Living.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: June 30, 2009
Last Update Posted: June 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Karwan e Hayat
Dow University of Health Sciences
Information provided by:
Pakistan Institute of Learning and Living
June 28, 2009
June 30, 2009
June 30, 2009
June 2009
September 2009   (Final data collection date for primary outcome measure)
acceptability and tolerability of simvastatin and ondansetron added to TAU [ Time Frame: 3 months ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
Role of Anti-Inflammatory Agents in Patients With Schizophrenia
Study of Role of Anti-Inflammatory Agents in Patients With Schizophrenia

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.

Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • Psychosis Not Otherwise Specified
  • Schizophreniform Disorder
  • 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
  • Active Comparator: Ondansetron
    Intervention: Drug: Ondansetron
  • Active Comparator: Simvastatin
    Intervention: Drug: Simvastatin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
September 2009
September 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, psychosis not otherwise specified or schizophreniform disorder
  2. competent and willing to give informed consent
  3. stable on medication 4 weeks prior to baseline
  4. able to take oral medication and likely to complete the required evaluations
  5. 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.

Exclusion Criteria:

  1. Relevant medical illness [renal and hepatic] in the opinion of the investigators
  2. history of high alcohol intake
  3. any change of psychotropic medications within the previous six weeks
  4. diagnosis of substance abuse (except nicotine or caffeine) or dependence within the last three months according to DSM-IV criteria
  5. pregnant or breast-feeding.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Dr Imran B Chaudhry, University of Manchester
Pakistan Institute of Learning and Living
  • Karwan e Hayat
  • Dow University of Health Sciences
Principal Investigator: Imran B Chaudhry, MD University of Manchester
Pakistan Institute of Learning and Living
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP