Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia

NCT01082588 | Completed Phase 4 Results DMC

• 2 other identifiers: 2009-P-00252409T-1296
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Schizophrenia; Schizoaffective Disorders; Schizophreniform Disorders

Keywords

schizophrenia; pravastatin; inflammation; cognition; antipsychotics; cholesterol

Outcome Measures

Primary Outcomes (7)

• Change in LDL-cholesterol Between Baseline and Week 12

  Baseline, week 12

• Change in C-Reactive Protein (CRP) From Baseline to Week 12

  Baseline, week 12

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

pravastatin

ACTIVE COMPARATOR

pravastatin 40mg, once a day, shortly after baseline for 12 consecutive weeks

Drug: Pravastatin

Placebo

PLACEBO COMPARATOR

placebo, once a day, shortly after baseline for 12 consecutive weeks

Drug: Placebo

Interventions

Pravastatin DRUG

pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks

Also known as: pravastatin sodium, Pravachol

pravastatin

Placebo DRUG

pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Stanley Medical Research Institute: collaborator
• North Suffolk Mental Health Association: collaborator

Study Sites (1)

Freedom Trail Clinic

Boston, Massachusetts, 02114, United States

Location

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MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Inflammation

Interventions

Pravastatin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Dr. David Henderson
• Organization: Massachusetts General Hospital

dchenderson@partners.org

617-912-7800

Study Officials

• David C Henderson, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 8, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 28, 2014
• Results First Posted: April 28, 2014

Record last verified: 2014-03

Locations

US (1)