NCT00605995

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 24, 2017

Status Verified

April 1, 2012

Enrollment Period

3.5 years

First QC Date

January 21, 2008

Last Update Submit

January 12, 2017

Conditions

Schizophrenia

Keywords

SchizophreniaRandomized trialStatinPlacebo

Outcome Measures

Primary Outcomes (1)

  • Positive and negative symptoms of schizophrenia

    12 weeks

Secondary Outcomes (1)

  • Serum inflammatory markers and cholesterol levels.

    12 weeks

Study Arms (2)

Simvastatin

EXPERIMENTAL

Simvastatin, 20 mg Tablet, given once daily. Dosage increased to 40 mg/day at the end of week 4 until endpoint.

Drug: Simvastatin

Placebo

PLACEBO COMPARATOR

Placebo pill, similar in its appearance to Simvastatin, taken once daily for the duration of the trial.

Drug: Simvastatin

Interventions

SimvastatinDRUG

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.

Also known as: Zocor
PlaceboSimvastatin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients speaking Spanish or English
  • Women using acceptable methods of birth control, including barrier method
  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Raz Gross, M.D., MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2008

First Posted

February 1, 2008

Study Start

February 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

March 24, 2017

Record last verified: 2012-04

Locations

IL(1)