Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia
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ClinicalTrials.gov Identifier: NCT01082588 |
Recruitment Status :
Completed
First Posted : March 8, 2010
Results First Posted : April 28, 2014
Last Update Posted : April 28, 2014
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia Schizoaffective Disorders Schizophreniform Disorders | Drug: Pravastatin Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Phase 4 Study of the Effects of Pravastatin on Cholesterol Levels, Inflammation and Cognition in Schizophrenia |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | September 2012 |
Actual Study Completion Date : | September 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: pravastatin
pravastatin 40mg, once a day, shortly after baseline for 12 consecutive weeks
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Drug: Pravastatin
pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Other Names:
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Placebo Comparator: Placebo
placebo, once a day, shortly after baseline for 12 consecutive weeks
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Drug: Placebo
pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks |
- Change in LDL-cholesterol Between Baseline and Week 12 [ Time Frame: Baseline, week 12 ]
- Change in C-Reactive Protein (CRP) From Baseline to Week 12 [ Time Frame: Baseline, week 12 ]
- Change in MATRICS Neuropsychological Battery Composite Score From Baseline to Week 12 [ Time Frame: Baseline, 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.
- Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 12 [ Time Frame: Baseline, 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.
- Change in Positive and Negative Syndrome Scale (PANSS) Positive Score From Baseline to Week 12 [ Time Frame: Baseline, 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.
- Change in Positive and Negative Syndrome Scale (PANSS) Negative Score From Baseline to Week 12 [ Time Frame: Baseline, 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.
- Change in Positive and Negative Syndrome Scale (PANSS) General Score From Baseline to Week 12 [ Time Frame: Baseline, 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 68 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01082588
United States, Massachusetts | |
Freedom Trail Clinic | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | David C Henderson, M.D. | Massachusetts General Hospital |
Responsible Party: | David C. Henderson, Associate Professor of Psychiatry, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01082588 |
Obsolete Identifiers: | NCT01363219 |
Other Study ID Numbers: |
2009-P-002524 09T-1296 ( Other Grant/Funding Number: Stanley Medical Research Institute ) |
First Posted: | March 8, 2010 Key Record Dates |
Results First Posted: | April 28, 2014 |
Last Update Posted: | April 28, 2014 |
Last Verified: | March 2014 |
schizophrenia pravastatin inflammation |
cognition antipsychotics cholesterol |
Disease Inflammation Schizophrenia Psychotic Disorders Pathologic Processes Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Pravastatin |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |