Schizophrenia
Conditions
Keywords
Schizophrenia, Randomized trial, Statin, Placebo
Brief summary
The overall purpose of this study is to determine whether the cholesterol-lowering drug simvastatin is effective in the treatment of symptoms of schizophrenia. The primary hypothesis is that patients with schizophrenia receiving add-on treatment with simvastatin will improve clinically (as measured mainly by symptom severity) compared with patients receiving placebo, and that this improvement will be accompanied by concomitant reduction in peripheral inflammatory markers.
Detailed description
The identification of alternative therapies with the capacity to dampen inflammatory processes and reduce serum cholesterol takes on additional significance given independent concerns about heightened cardiovascular risk in schizophrenia patients, through exposure to antipsychotic drugs, increased cholesterol levels, metabolic syndrome and obesity, and smoking.
Interventions
DRUGSimvastatin
20 mg taken orally once daily for the first 4 weeks. Dosage will be increased to 40 mg/day at the end of week 4.
Sponsors
Stanley Medical Research Institute
Sheba Medical Center
Merck Sharp & Dohme LLC
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-70 years * Available for follow up during the study protocol * DSM-IV schizophrenia * Positive and Negative Syndrome Scale (PANSS) baseline score of ≥50 * Score of 3 or higher on the Severity of Illness scale of the Clinical Global Impression (CGI) * Not completely refractory to antipsychotics: evidence for at least partial responsiveness to antipsychotic medication * Evidence for current clinical stability * Capacity to provide informed consent * Provided informed consent * Patients taking concomitant, non-investigational medications that are not listed in
Exclusion criteria
#1 * Patients speaking Spanish or English * Women using acceptable methods of birth control, including barrier method
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive and negative symptoms of schizophrenia | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Serum inflammatory markers and cholesterol levels. | 12 weeks |
Countries
Israel
Outcome results
None listed