Simvastatin Addition for Patients With Recent-onset Schizophrenia
Status:
Completed
Trial end date:
2019-12-19
Target enrollment:
Participant gender:
Summary
Rationale: There is ample evidence that inflammatory processes play a role in the
pathophysiology of schizophrenia. Although Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
have been shown to be able to reduce symptoms in these patients, these drugs either have
unfavourable cardiovascular side effects or are otherwise not well tolerated. Moreover,
patients with schizophrenia already tend to have an increased cardiovascular risk. The
combination of well-established vascular protection and reduction of inflammation by
simvastatin offers a highly attractive potential to further improve the treatment of
schizophrenia and related disorders.
Hypotheses: Daily treatment with 40mg simvastatin in addition to antipsychotic treatment
reduces psychotic symptoms, improves cognition, attenuates brain volume loss, and decreases
the risk for metabolic syndrome as well as for movement disorders, when compared to placebo.
Objective: The primary objective of this trial is to investigate the proposed beneficial
effect of simvastatin as compared to placebo when given for one year in addition to
antipsychotic medication to patients with psychotic disorder. We expect lower symptom
severity as measured with the PANSS (Positive and Negative Syndrome Scale) and less cognitive
decline as measured with the BACS (Brief Assessment of Cognition in Schizophrenia).Secondary
objectives are assessment of general functioning, presence and severity of metabolic syndrome
and degree of movement disorders, and assessments of brain volume. Lastly, we examine various
immunological parameters in serum and peripheral blood mononuclear cells and the experience
of childhood trauma.
Study design: Randomized placebo-controlled double-blind trial.
Study population: 150 men and women, between 18 and 50 years of age, diagnosed with
schizophrenia, schizoaffective or schizophreniform disorder (DSM-IV 295.*) or psychosis NOS
(not otherwise specified) (298.9). Onset of first psychosis no longer than 3 years ago.
Intervention: Patients will be randomized 1:1 to either 40 mg simvastatin or placebo daily,
in the form of identical tablets.