Add-on Simvastatin in Schizophrenia Trial

Schizophrenia Clinical Trial

— ASSIST  

Official title:

Add-on Simvastatin in Schizophrenia Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00605995
• Other study ID #: 5207
• Secondary ID: SMRI-05T-693
• Status: Terminated
• Phase: N/A
• First received: January 21, 2008
• Last updated: April 27, 2012
• Start date: February 2008
• Est. completion date: August 2011

Study information

• Verified date: April 2012
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardIsrael: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan
United States	Columbia University Medical Center	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Merck Sharp & Dohme Corp., Sheba Medical Center, Stanley Medical Research Institute

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and negative symptoms of schizophrenia		12 weeks	No
Secondary	Serum inflammatory markers and cholesterol levels.		12 weeks	No