Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT00772005
Status:
COMPLETED
Last Update Posted:
2012-07-27
First Post:
2008-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia
Sponsor:
Cephalon
Organization:
Study Overview
Official Title:
A 24-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil (150, 200, and 250 mg/ Day) as Adjunctive Therapy in Adults With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2012-06
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:
None
Brief Summary:
The primary objective of the study is to evaluate whether armodafinil treatment is more effective than placebo as adjunctive therapy to antipsychotic medication in alleviating the negative symptoms of schizophrenia
Detailed Description:
This study was designed and was powered to evaluate the efficacy and safety of armodafinil treatment at dosages of 150, 200, and 250 mg/day compared with placebo over 24 weeks as an adjunctive therapy to antipsychotic medication (olanzapine, oral risperidone, or paliperidone) in adults with schizophrenia who were clinically stable at study entry. Specifically, the effects of armodafinil treatment on the negative symptoms of schizophrenia were the primary assessment in this study.
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?: