Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT01354132
Status:
COMPLETED
Last Update Posted:
2017-07-05
First Post:
2011-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
N-Acetyl-Cysteine (NAC) in Early Phase Schizophrenia Spectrum Psychosis
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Study Overview
Official Title:
Effects of Oral N-Acetyl-Cysteine (NAC) in the Early Phase of Schizophrenia Spectrum Psychosis: Randomized, Parallel, Double- Blind, Placebo Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NACPSY
Brief Summary:
The investigators seek to examine the effect of add-on N-Acetyl-Cysteine (NAC) in the early phase of schizophrenia spectrum illness in collaboration with researchers Kim Do, PhD, and Philippe Conus, MD in Switzerland. Modifications of brain structure are thought to occur during the pre-illness phase and around the transition to psychosis. Therefore, studying new treatments that could target changes occurring during this period is of critical importance.
Aims:
Does add-on NAC treatment in early psychosis influence:
* positive and negative symptoms
* extrapyramidal side-effects of other medication
* plasma concentration of glutathione
* Mismatch Negativity, a physiological marker
Aims:
Does add-on NAC treatment in early psychosis influence:
* positive and negative symptoms
* extrapyramidal side-effects of other medication
* plasma concentration of glutathione
* Mismatch Negativity, a physiological marker
Detailed Description:
The study proposes that a glutathione deficit leading to an abnormal response to oxidative stress is a vulnerability factor, combined with other brain specific factors, in brain functioning of some individuals with schizophrenia (Do et al., 2010). N-acetyl-cysteine is hypothesized to cross the blood-brain barrier and increase glutathione in the brain.
Study Oversight
Has Oversight DMC:
True
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 |
|---|---|---|---|---|
| 107865 | OTHER | FDA IND | View |