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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00929955
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.
Collaborators:
Karwan e Hayat
Dow University of Health Sciences
Information provided by:
Pakistan Institute of Learning and Living
  Purpose

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.


Condition Intervention Phase
Schizophrenia Schizoaffective Disorder Psychosis Not Otherwise Specified Schizophreniform Disorder Drug: Ondansetron Drug: Simvastatin Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Study of Role of Anti-Inflammatory Agents in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Pakistan Institute of Learning and Living:

Primary Outcome Measures:
  • acceptability and tolerability of simvastatin and ondansetron added to TAU [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 36
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)
Arms Assigned Interventions
Active Comparator: Ondansetron Drug: Ondansetron
ondansetron added to TAU Ondansetron will be administered in 8mg once daily dose
Active Comparator: Simvastatin Drug: Simvastatin
Simvastatin added to TAU Simvastatin 20mg taken as once daily dose
Placebo Comparator: Placebo Drug: Placebo
Placebo added to TAU

  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929955


Contacts
Contact: Imran B Chaudhry, MD +441254226392 imran.chaudhry@manchester.ac.uk
Contact: Nusrat Husain, MD +441254226392 nusrat.husain@manchester.ac.uk

Locations
Pakistan
Dow University of Health Sciences Recruiting
Karachi, Pakistan
Contact: Raza ur Rahman    +923002579364    razaur@yahoo.com   
Karwan e hayat Recruiting
Karachi, Pakistan
Contact: Ajmal Kazmi, MRCPsych    +923213783890    kazmiajmal@yahoo.com   
Sponsors and Collaborators
Pakistan Institute of Learning and Living
Karwan e Hayat
Dow University of Health Sciences
Investigators
Principal Investigator: Imran B Chaudhry, MD University of Manchester
  More Information

Responsible Party: Dr Imran B Chaudhry, University of Manchester
ClinicalTrials.gov Identifier: NCT00929955     History of Changes
Other Study ID Numbers: PILL-UoM-0110
First Submitted: June 28, 2009
First Posted: June 30, 2009
Last Update Posted: June 30, 2009
Last Verified: June 2009

Keywords provided by Pakistan Institute of Learning and Living:
Anti inflammatory
Schizophrenia
Simvastatin
ondansetron

Additional relevant MeSH terms:
Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Simvastatin
Ondansetron
Anti-Inflammatory Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs