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
  Purpose

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.


Condition Intervention
Schizophrenia
Drug: Simvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Add-on Simvastatin in Schizophrenia Trial

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Positive and negative symptoms of schizophrenia [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum inflammatory markers and cholesterol levels. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: February 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Placebo Comparator: 2 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605995

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Israel
Sheba Medical Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
New York State Psychiatric Institute
Stanley Medical Research Institute
Sheba Medical Center
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Raz Gross, M.D., MPH Columbia University
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00605995     History of Changes
Other Study ID Numbers: 5207, SMRI-05T-693
Study First Received: January 21, 2008
Last Updated: April 27, 2012
Health Authority: United States: Institutional Review Board
Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014