Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Phase 4 Study of the Effects of Pravastatin on Cholesterol Levels, Inflammation and Cognition in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01082588
• Other study ID #: 2009-P-002524
• Secondary ID: 09T-1296
• Status: Completed
• Phase: Phase 4
• First received: March 5, 2010
• Last updated: March 26, 2014
• Start date: June 2010
• Est. completion date: September 2012

Study information

• Verified date: March 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Description:

This study is a 12-week randomized, double-blind, placebo-controlled pilot study of pravastatin 40mg a day, administered for 12 consecutive weeks to subjects with schizophrenia to examine pravastatin's effects on lowering cholesterol levels and inflammatory markers, and improving cognition. The study will be conducted at the Freedom Trail Clinic and will use the Massachusetts General Hospital Clinical Research Center. The innovative approach of using pravastatin to not only decrease cholesterol levels, but to decrease inflammation and improve cognition in patients with schizophrenia is promising and may lead to a different approach to treatment in this population.

Other known NCT identifiers

• NCT01363219

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 68 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Inflammation
• Psychotic Disorders
• Schizoaffective Disorders
• Schizophrenia
• Schizophreniform Disorders

Intervention

Drug:
• Pravastatin
pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
• Placebo
pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks

Locations

Country	Name	City	State
United States	Freedom Trail Clinic	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	North Suffolk Mental Health Association, Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

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* Note: There are 68 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LDL-cholesterol Between Baseline and Week 12		Baseline, week 12	No
Primary	Change in C-Reactive Protein (CRP) From Baseline to Week 12		Baseline, week 12	No
Primary	Change in MATRICS Neuropsychological Battery Composite Score From Baseline to Week 12	The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery measures cognitive functioning within 7 domains: speed of processing, attention/vigilance, working memory (non verbal and verbal), verbal learning, visual learning, reasoning and problem solving and social cognition.; The composite score is calculated by the MATRICS computer program, which equally weights each of the 7 domain scores. The range of composite scores is 20-80. Higher scores indicate higher levels or cognitive functioning, while lower scores indicate lower levels of cognitive functioning.	Baseline, week 12	No
Primary	Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 12	The Positive and Negative Syndrome Scale (PANSS) is a scale used to rate severity of schizophrenia. All items are summed to calculate the total score. The scale range is 30-210. Better outcomes have lower numbers and worse outcomes have higher numbers.	Baseline, week 12	No
Primary	Change in Positive and Negative Syndrome Scale (PANSS) Positive Score From Baseline to Week 12	This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 7-49. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers.	Baseline, week 12	No
Primary	Change in Positive and Negative Syndrome Scale (PANSS) Negative Score From Baseline to Week 12	This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 7-49. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers.	Baseline, week 12	No
Primary	Change in Positive and Negative Syndrome Scale (PANSS) General Score From Baseline to Week 12	This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 15-105. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers.	Baseline, week 12	No