CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Pravastatin +1 moredrug
Likely dose
Pravastatin 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01082588
NCT01082588Phase 4Completed
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Phase 4 Study of the Effects of Pravastatin on Cholesterol Levels, Inflammation and Cognition in Schizophrenia

Massachusetts General Hospital·interventional·Posted Mar 8, 2010·Updated Apr 28, 2014

In Brief

A Phase 4 clinical trial evaluating Pravastatin and Placebo for Schizophrenia and 2 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorders, Schizophreniform Disorders
CountriesUnited States
CollaboratorsStanley Medical Research Institute, North Suffolk Mental Health Association

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 8, 2010
Enrollment StartJun 1, 2010
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.3 years ago

Interventions

Pravastatindrug

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

Placebodrug

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