Add-on Simvastatin in Schizophrenia Trial

NCT ID: NCT00605995

Last Updated: 2017-03-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2011-08-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Simvastatin

Simvastatin, 20 mg Tablet, given once daily. Dosage increased to 40 mg/day at the end of week 4 until endpoint.

Group Type: EXPERIMENTAL

Simvastatin

Intervention Type: DRUG

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.

Placebo

Placebo pill, similar in its appearance to Simvastatin, taken once daily for the duration of the trial.

Group Type: PLACEBO_COMPARATOR

Simvastatin

Intervention Type: DRUG

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.

Interventions

Simvastatin

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.

Intervention Type: DRUG

Other Intervention Names

Zocor

Eligibility Criteria

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

Exclusion Criteria

• Patients speaking Spanish or English
• Women using acceptable methods of birth control, including barrier method

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanley Medical Research Institute

OTHER

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raz Gross, M.D., MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

SMRI-05T-693

Identifier Type: OTHER

Identifier Source: secondary_id

5207

Identifier Type: -

Identifier Source: org_study_id