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Updated: Nov 16, 2025

Vagus Nerve Stimulation As an Adjunctive Neurostimulation Tool in Treatment-resistant Depression

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Published on: January 7, 2019

Simvastatin Augmentation for Patients With Early-Phase Schizophrenia-Spectrum Disorders: A Double-Blind, Randomized

Iris E Sommer^1,2, Shiral S Gangadin¹, Lot D de Witte³

¹Department of Biomedical Sciences of Cells & Systems, University Medical Center Groningen (UMCG), University of Groningen, Groningen, the Netherlands.

Schizophrenia Bulletin

|February 20, 2021

Summary

Simvastatin augmentation did not improve overall schizophrenia-spectrum disorder symptoms or cognition long-term. However, early symptom reduction was observed, with fewer serious adverse events compared to placebo.

Keywords:

RCT inflammation schizophrenia simvastatin symptoms

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Area of Science:

Neuroscience
Psychiatry
Pharmacology

Background:

Schizophrenia-spectrum disorders (SSD) involve heightened inflammation.
Targeting inflammation with drugs like simvastatin may offer therapeutic benefits.
Simvastatin has anti-inflammatory and neuroprotective properties and crosses the blood-brain barrier.

Purpose of the Study:

To evaluate the efficacy of simvastatin as an add-on therapy for early SSD.
To assess the impact of simvastatin on symptom severity and cognitive function over 12 months.
To investigate secondary outcomes including depression, functioning, and safety.

Main Methods:

A 12-month, double-blind, placebo-controlled trial involving 119 patients with early SSD.
Random assignment to simvastatin (40 mg) or placebo, stratified by sex and site.
Intention-to-treat analyses using linear mixed models and ANCOVA for primary and secondary outcomes.

Main Results:

No significant main effect of simvastatin on overall symptom severity or cognition after 12 months.
Symptom severity was significantly lower in the simvastatin group at 6 months and 24 months follow-up.
Fewer serious adverse events were reported in the simvastatin group compared to placebo.

Conclusions:

Simvastatin augmentation does not provide a significant long-term clinical benefit for SSD symptoms or cognition.
The findings align with other large-scale studies on anti-inflammatory agents in SSD.
Anti-inflammatory augmentation strategies may not be effective for improving the overall clinical presentation of SSD.