Add-on Simvastatin in Schizophrenia Trial (ASSIST)

This study has been terminated.
(Study was stopped because enrollment was slower than anticipated by the investigators and the foundation funding the study.)
Sponsor:
Collaborators:
Stanley Medical Research Institute
Sheba Medical Center
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00605995
First received: January 21, 2008
Last updated: April 27, 2012
Last verified: April 2012

January 21, 2008
April 27, 2012
February 2008
August 2011   (final data collection date for primary outcome measure)
Positive and negative symptoms of schizophrenia [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00605995 on ClinicalTrials.gov Archive Site
Serum inflammatory markers and cholesterol levels. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Add-on Simvastatin in Schizophrenia Trial
Add-on Simvastatin in Schizophrenia Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
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.
Other Name: Zocor
  • Experimental: 1
    Intervention: Drug: Simvastatin
  • Placebo Comparator: 2
    Intervention: Drug: Simvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
23
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Israel
 
NCT00605995
5207, SMRI-05T-693
No
New York State Psychiatric Institute
New York State Psychiatric Institute
  • Stanley Medical Research Institute
  • Sheba Medical Center
  • Merck Sharp & Dohme Corp.
Principal Investigator: Raz Gross, M.D., MPH Columbia University
New York State Psychiatric Institute
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP