Add-on Simvastatin in Schizophrenia Trial

• Age 18-70 years
• Available for follow up during the study protocol
• DSM-IV schizophrenia
• Positive and Negative Syndrome Scale (PANSS) baseline score of ≥50
• Score of 3 or higher on the Severity of Illness scale of the Clinical Global Impression (CGI)
• Not completely refractory to antipsychotics: evidence for at least partial responsiveness to antipsychotic medication
• Evidence for current clinical stability
• Capacity to provide informed consent
• Provided informed consent
• Patients taking concomitant, non-investigational medications that are not listed in Exclusion Criteria #1
• Patients speaking Spanish or English
• Women using acceptable methods of birth control, including barrier method

Exclusion Criteria:

• Currently taking a statin OR any of the following:

  • Other lipid-lowering drug;
  • Anti-inflammatory drugs or aspirin;
  • Systemic antibiotic, anti-viral or anti-fungal drugs (within the past 4 weeks);
  • Potent inhibitors of the cytochrome P450 isoform 3A4 (CYP3A4);
  • Digoxin (Lanoxin®), nefazodone (Serzone®), niacin, cyclosporine (Neoral®, Sandimmune®), danazol, warfarin (Coumadin®), amiodarone, verapamil, Cordarone®, or Inderal®.
• Patients with known hypersensitivity to simvastatin or any other statin drug
• Active liver disease or unexplained persistent elevations of serum transaminases
• Renal insufficiency
• Serious or unstable medical condition that require close medical attention, such as cancer, unstable heart failure, uncontrolled hypertension/asthma/COPD
• Current drug use disorder (abuse/dependence)
• Pregnancy and lactation
• Psychiatric disorders other than schizophrenia or schizoaffective disorder requiring pharmacotherapy
• Suicidal or homicidal intent
• Severe cognitive impairment that might compromise competency to sign informed consent or the validity of the cognitive outcome measure
• Organic brain disorder, including epilepsy; mental retardation; or a medical condition whose pathology or treatment would likely alter the presentation or treatment of schizophrenia
• Current participation in another clinical trial
• Patients on more than 2 anti-psychotic medications (patients will not be tapered off effective medications for the purpose of participating in research)
• LDL cholesterol >100 mg/dL with known coronary hard disease. LDL cholesterol >130 mg/dl with 2 or more of the following risk factors: smoking; hypertension; low HDL cholesterol (\<40 mg/dL); age >45 years (men) or age >55 years (women); family history of premature CHD (CHD in 1st degree relative male\<55; female \<65