Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212784
Status:
COMPLETED
Last Update Posted:
2022-02-16
First Post:
2005-09-13
Brief Title:
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder 25517P05935
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A Phase III Double-Blind Randomized Active-Controlled Two-Armed Multicenter Efficacy and Safety Assessment ACTAMESA of Org 5222 and Olanzapine in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
Status:
COMPLETED
Status Verified Date:
2022-02
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 features of schizophrenia and schizoaffective disorder are characterized by positive inability to think clearly and distinguish reality from fantasy and negative symptoms reduction or absence of normal behavior or emotions Other symptoms include reduced ability to recall and learn information difficulty in problem solving or maintaining productive employment Asenapine is an investigational drug that may help to correct the above characteristics of schizophrenia by altering the inbalance of brain hormones such as dopamine and serotonin This is a 12-month trial that will test the efficacy and safety of asenapine using an active comparator olanzapine in the treatment of patients with schizophrenia Patients who complete the 12-month trial will have the option of continuing on drug until the treatment code for the 12-month trial is unblinded
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTAMESA 25517 | None | None | None |