Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-01-06 @ 10:34 PM
Study NCT ID:
NCT00605995
Status:
TERMINATED
Last Update Posted:
2017-03-24
First Post:
2008-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Add-on Simvastatin in Schizophrenia Trial
Sponsor:
New York State Psychiatric Institute
Organization:
Study Overview
Official Title:
Add-on Simvastatin in Schizophrenia Trial
Status:
TERMINATED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment was slower than anticipated by the investigators and the funding research foundation.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASSIST
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| SMRI-05T-693 | OTHER | protocol | View |