Add-on Simvastatin in Schizophrenia Trial (ASSIST)

New York State Psychiatric Institute

Status

Terminated

Conditions

Schizophrenia

Treatments

Drug: Simvastatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00605995

5207

SMRI-05T-693 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Exclusion criteria

Currently taking a statin OR any of the following:
- Other lipid-lowering drug;
- Anti-inflammatory drugs or aspirin;
- Systemic antibiotic, anti-viral or anti-fungal drugs (within the past 4 weeks);
- Potent inhibitors of the cytochrome P450 isoform 3A4 (CYP3A4);
- Digoxin (Lanoxin®), nefazodone (Serzone®), niacin, cyclosporine (Neoral®, Sandimmune®), danazol, warfarin (Coumadin®), amiodarone, verapamil, Cordarone®, or Inderal®.
Patients with known hypersensitivity to simvastatin or any other statin drug
Active liver disease or unexplained persistent elevations of serum transaminases
Renal insufficiency
Serious or unstable medical condition that require close medical attention, such as cancer, unstable heart failure, uncontrolled hypertension/asthma/COPD
Current drug use disorder (abuse/dependence)
Pregnancy and lactation
Psychiatric disorders other than schizophrenia or schizoaffective disorder requiring pharmacotherapy
Suicidal or homicidal intent
Severe cognitive impairment that might compromise competency to sign informed consent or the validity of the cognitive outcome measure
Organic brain disorder, including epilepsy; mental retardation; or a medical condition whose pathology or treatment would likely alter the presentation or treatment of schizophrenia
Current participation in another clinical trial
Patients on more than 2 anti-psychotic medications (patients will not be tapered off effective medications for the purpose of participating in research)
LDL cholesterol >100 mg/dL with known coronary hard disease. LDL cholesterol >130 mg/dl with 2 or more of the following risk factors: smoking; hypertension; low HDL cholesterol (<40 mg/dL); age >45 years (men) or age >55 years (women); family history of premature CHD (CHD in 1st degree relative male<55; female <65