Role of Anti-Inflammatory Agents in Patients With Schizophrenia
Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
Pakistan Institute of Learning and Living Pakistan Institute of Living and Learning