Add-on Simvastatin in Schizophrenia Trial (ASSIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00605995
Recruitment Status : Terminated (Enrollment was slower than anticipated by the investigators and the funding research foundation.)
First Posted : February 1, 2008
Last Update Posted : March 24, 2017
Stanley Medical Research Institute
Sheba Medical Center
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Simvastatin Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Add-on Simvastatin in Schizophrenia Trial
Study Start Date : February 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Simvastatin

Arm Intervention/treatment
Experimental: Simvastatin
Simvastatin, 20 mg Tablet, given once daily. Dosage increased to 40 mg/day at the end of week 4 until endpoint.
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: Placebo
Placebo pill, similar in its appearance to Simvastatin, taken once daily for the duration of the trial.
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

Primary Outcome Measures :
  1. Positive and negative symptoms of schizophrenia [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Serum inflammatory markers and cholesterol levels. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00605995

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.
Principal Investigator: Raz Gross, M.D., MPH Columbia University

Responsible Party: New York State Psychiatric Institute Identifier: NCT00605995     History of Changes
Other Study ID Numbers: 5207
SMRI-05T-693 ( Other Identifier: protocol )
First Posted: February 1, 2008    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: April 2012

Keywords provided by New York State Psychiatric Institute:
Randomized trial

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors