Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorders; Schizophreniform Disorders
MeSH terms: Inflammation; Schizophrenia; Psychotic Disorders
Intervention: Pravastatin; Placebo
Intervention description: pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks; pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Intervention MeSH terms: Pravastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 68 Years
Healthy volunteers: No
Keywords: schizophrenia; pravastatin; inflammation; cognition; antipsychotics; cholesterol

Summary:

      This study involves people with schizophrenia or schizoaffective disorder, who are currently
      taking antipsychotic medications. Some antipsychotic medications may cause an increase in
      cholesterol levels, which may lead to inflammation in the body. Inflammation poses a risk in
      developing heart disease, diabetes and problems with brain function. The purpose of this
      study is to see if pravastatin can:

        -  Lower cholesterol

        -  Decrease inflammation

        -  Improve cognition in patients with schizophrenia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female

          -  Age 18-68 years

          -  Diagnosis of schizophrenia, any subtype, schizoaffective disorder, any subtype or
             schizophreniform disorder

          -  Well established compliance with outpatient medications including their antipsychotic
             medication

        Exclusion Criteria:

          -  Inability to provide informed consent

          -  Current substance and alcohol abuse

          -  Significant medical illness, including congestive heart failure, severe cardiovascular
             disease, renal disease (serum creatinine > 1.5), severe hepatic impairment or active
             liver disease, anemia (hemoglobin <11.0 gm/dL), history of severe head injury, and not
             treated muscle disease.

          -  Psychiatrically unstable

          -  Women of child bearing potential who are pregnant, breastfeeding, or who are unwilling
             or unable to use an effective form of birth control during the entire study

          -  Subjects treated with anti-inflammatory drugs (including daily aspirin and ibuprofen),
             thiazide diuretics; agents that induce weight loss, and St. John's Wort will be
             excluded from the study

          -  Current history of untreated thyroid disease

          -  Current treatment with insulin

          -  Subjects being treated with drugs such as: colchicine, azole antifungals (fluconazole,
             ketoconazole, itraconazole); macrolide antibiotics (clarithromycin, erythromycin); HIV
             protease inhibitors (ritonavir, indinavir, saquinavir, nelfinavir) that inhibit the
             CYP 450 3A liver enzyme

          -  Known hypersensitivity to pravastatin or any of its components