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Study of Role of Anti-Inflammatory Agents in Patients With Schizophrenia

Phase 1
18 Years
65 Years
Open (Enrolling)
Schizophrenia, Schizoaffective Disorder, Psychosis Not Otherwise Specified, Schizophreniform Disorder

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Trial Information

Study of Role of Anti-Inflammatory Agents in Patients With Schizophrenia

Inclusion Criteria:

1. Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of schizophrenia,
schizoaffective disorder, psychosis not otherwise specified or schizophreniform

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.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

acceptability and tolerability of simvastatin and ondansetron added to TAU

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Imran B Chaudhry, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Manchester


Pakistan: Research Ethics Committee

Study ID:




Start Date:

June 2009

Completion Date:

September 2009

Related Keywords:

  • Schizophrenia
  • Schizoaffective Disorder
  • Psychosis Not Otherwise Specified
  • Schizophreniform Disorder
  • Anti inflammatory
  • Schizophrenia
  • Simvastatin
  • ondansetron
  • Mental Disorders
  • Psychotic Disorders
  • Schizophrenia