Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia

This study has been completed.

Sponsor:

Collaborators:

Stanley Medical Research Institute

North Suffolk Mental Health Association

Information provided by (Responsible Party):

David C. Henderson, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01082588

First received: March 5, 2010

Last updated: March 26, 2014

Last verified: March 2014

History of Changes

Purpose

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	Intervention	Phase
Schizophrenia Schizoaffective Disorders Schizophreniform Disorders	Drug: Pravastatin Drug: Placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Phase 4 Study of the Effects of Pravastatin on Cholesterol Levels, Inflammation and Cognition in Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Schizophrenia

Drug Information available for: Pravastatin Pravastatin sodium

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Change in LDL-cholesterol Between Baseline and Week 12 [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
Change in C-Reactive Protein (CRP) From Baseline to Week 12 [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
Change in MATRICS Neuropsychological Battery Composite Score From Baseline to Week 12 [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.


Enrollment:	60
Study Start Date:	June 2010
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: pravastatin pravastatin 40mg, once a day, shortly after baseline for 12 consecutive weeks	Drug: Pravastatin pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks Other Names: pravastatin sodium Pravachol
Placebo Comparator: Placebo placebo, once a day, shortly after baseline for 12 consecutive weeks	Drug: Placebo pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks Other Name: placebo

Detailed 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.

Eligibility


Ages Eligible for Study:	18 Years to 68 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082588

Locations


United States, Massachusetts
Freedom Trail Clinic
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Stanley Medical Research Institute

North Suffolk Mental Health Association

Investigators


Principal Investigator:	David C Henderson, M.D.	Massachusetts General Hospital

More Information

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Responsible Party:	David C. Henderson, Associate Professor of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01082588 History of Changes
Obsolete Identifiers:	NCT01363219
Other Study ID Numbers:	2009-P-002524, 09T-1296
Study First Received:	March 5, 2010
Results First Received:	November 20, 2013
Last Updated:	March 26, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:


schizophrenia pravastatin inflammation	cognition antipsychotics cholesterol

Additional relevant MeSH terms:


Disease Inflammation Schizophrenia Mental Disorders Pathologic Processes Schizophrenia and Disorders with Psychotic Features Pravastatin Anticholesteremic Agents	Antimetabolites Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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