Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156104
Status:
COMPLETED
Last Update Posted:
2022-02-16
First Post:
2005-09-07
Brief Title:
Efficacy and Safety of Asenapine With Placebo and Haloperidol 41023P05926COMPLETED
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Fixed-Dose 6-Week Trial of the Efficacy and Safety of Asenapine Compared With Placebo Using Haloperidol Positive Control in Subjects With an Acute Exacerbation of Schizophrenia
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:
Schizophrenia is a brain disease The primary features of schizophrenia are characterized by Positive symptoms symptoms that should not be there inability to think clearly to distinguish reality from fantasy ie hearing voices and Negative symptoms a reduction or absence of normal behaviors or emotions ie unable to manage emotions make decisions and relate to others Other symptoms include reduced ability to recall and learn new information difficulty with problem solving or maintaining productive employment The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain primarily dopamine and serotonin which enables brain cells to communicate with each other
Asenapine is an investigational drug that may help to correct the inbalance in dopamine and serotonin This is a 6-week trial to test the efficacy and safety of asenapine compared with placebo using an active comparator agent haloperidol in the treatment of patients with an acute exacerbation of schizophrenia Patients who complete the 6-week trial will have the option of continuing in an additional one year extension trial
Asenapine is an investigational drug that may help to correct the inbalance in dopamine and serotonin This is a 6-week trial to test the efficacy and safety of asenapine compared with placebo using an active comparator agent haloperidol in the treatment of patients with an acute exacerbation of schizophrenia Patients who complete the 6-week trial will have the option of continuing in an additional one year extension trial
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 |
|---|---|---|---|
| 41023 | None | None | None |
| Hera | None | None | None |