Add-on Simvastatin in Schizophrenia Trial - Full Text View

Sponsor:	Columbia University
Collaborators:	Stanley Medical Research Institute Sheba Medical Center Merck
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00605995

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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Add-on Simvastatin in Schizophrenia Trial

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Schizophrenia

Drug Information available for: Simvastatin

U.S. FDA Resources

Further study details as provided by Columbia University:

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 ]

Estimated Enrollment:	80
Study Start Date:	February 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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.
2: Placebo Comparator	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.

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605995

Contacts

Contact: Raz Gross, M.D., MPH

212-304-6591

rg547@columbia.edu

Locations

United States, New York
Columbia University Medical Center	Not yet recruiting
New York, New York, United States, 10032
Sub-Investigator: Elizabeth LeQuesne, M.D.
Israel
Sheba Medical Center	Recruiting
Ramat Gan, Israel, 52621
Contact: Mark Weiser, M.D. 972-52-666-6575 mweiser@netvision.net.il
Contact: Yifat Kronenfeld, M.Sc. 03-530-3454 yifatkro@gmail.com
Principal Investigator: Mark Weiser, M.D.

Sponsors and Collaborators

Columbia University

Stanley Medical Research Institute

Sheba Medical Center

Merck

Investigators

Principal Investigator:

Raz Gross, M.D., MPH

Columbia University

More Information

No publications provided

Responsible Party:	Columbia University ( Raz Gross, M.D., MPH, Assistant Professor of Clinical Epidemiology and Clinical Psychiatry )
Study ID Numbers:	SMRI-05T-693
Study First Received:	January 21, 2008
Last Updated:	February 2, 2009
ClinicalTrials.gov Identifier:	NCT00605995 History of Changes
Health Authority:	United States: Institutional Review Board; Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:

Antimetabolites
Schizophrenia
Molecular Mechanisms of Pharmacological Action
Simvastatin
Mental Disorders
Therapeutic Uses

Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 08, 2010