Phase 4
Completed N=60
Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia
Schizophrenia · Schizoaffective Disorders · Schizophreniform Disorders
Source: ClinicalTrials.gov NCT01082588 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcomePrimary: Change in LDL-cholesterol Between Baseline and Week 12 — -25.565; -2.913 mg/dl
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in LDL-cholesterol Between Baseline and Week 12 |
-25.565; -2.913 | — |
| PRIMARY Change in C-Reactive Protein (CRP) From Baseline to Week 12 |
0.8063; -0.5136 | — |
| PRIMARY Change in MATRICS Neuropsychological Battery Composite Score From Baseline to Week 12 |
4.0417; 4.125 | — |
| PRIMARY Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 12 |
-9.416; -6.48 | — |
| PRIMARY Change in Positive and Negative Syndrome Scale (PANSS) Positive Score From Baseline to Week 12 |
-2.9583; -2.44 | — |
| PRIMARY Change in Positive and Negative Syndrome Scale (PANSS) Negative Score From Baseline to Week 12 |
-0.83; -0.28 | — |
| PRIMARY Change in Positive and Negative Syndrome Scale (PANSS) General Score From Baseline to Week 12 |
-5.625; -3.76 | — |
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
Data sourced from ClinicalTrials.gov (NCT01082588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.