Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia
NCT ID: NCT01082588
Last Updated: 2014-04-28
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-06-30
Study Completion Date
2012-09-30
Brief Summary
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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
* Lower cholesterol
* Decrease inflammation
* Improve cognition in patients with schizophrenia
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Detailed Description
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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.
Conditions
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Schizophrenia
Schizoaffective Disorders
Schizophreniform Disorders
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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pravastatin
pravastatin 40mg, once a day, shortly after baseline for 12 consecutive weeks
Group Type
ACTIVE_COMPARATOR
Pravastatin
Intervention Type
DRUG
pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Placebo
placebo, once a day, shortly after baseline for 12 consecutive weeks
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Interventions
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Pravastatin
pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Intervention Type
DRUG
Placebo
pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Intervention Type
DRUG
Other Intervention Names
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pravastatin sodium
Pravachol
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
68 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Stanley Medical Research Institute
OTHER
Sponsor Role
collaborator
North Suffolk Mental Health Association
OTHER
Sponsor Role
collaborator
Massachusetts General Hospital
OTHER
Sponsor Role
lead
Responsible Party
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David C. Henderson
Associate Professor of Psychiatry
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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David C Henderson, M.D.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Freedom Trail Clinic
Boston, Massachusetts, United States
Site Status
Countries
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United States
References
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Reference Type
BACKGROUND
Otvos JD. Measurement of lipoprotein subclass profiles by nuclear magnetic resonance spectroscopy. Clin Lab. 2002;48(3-4):171-80. No abstract available.
Reference Type
BACKGROUND
Levine S. The management of resistant depression. Acta Psychiatr Belg. 1986 Mar-Apr;86(2):141-51.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
09T-1296
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2009-P-002524
Identifier Type: -
Identifier Source: org_study_id
NCT01363219
Identifier Type: -
Identifier Source: nct_alias
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