Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156065
Status:
COMPLETED
Last Update Posted:
2022-02-08
First Post:
2005-09-07
Brief Title:
Long-Term Efficacy and Safety of Asenapine Using Haloperidol as a Positive Control 41513COMPLETEDP05785
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Flexible-Dose Long-Term Extension Trial of the Safety and Maintenance of Effect of Asenapine Using Haloperidol Positive Control in Subjects Who Complete Protocol 041023 NCT00156104
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
The clinical development of asenapine as described in the 2007 IDB appears to have antipsychotic activity with superior symptomatic control compared to placebo and an improved safety profile compared to currently available neuroleptics Its fast dissolving formulation may further add to treatment compliance While various titration schedules have been used in previous studies dose increases at 5 mg BID twice daily up to 10 mg BID have been well tolerated Therefore further exploration in a larger group of subjects with acute exacerbation of schizophrenia using an asenapine flexible dosing design 5 or 10 mg BID will mimic actual clinical practice in a long-term 52-week extension trial
The clinical development of asenapine as described in the 2007 IDB appears to have antipsychotic activity with superior symptomatic control compared to placebo and an improved safety profile compared to currently available neuroleptics Its fast dissolving formulation may further add to treatment compliance While various titration schedules have been used in previous studies dose increases at 5 mg BID twice daily up to 10 mg BID have been well tolerated Therefore further exploration in a larger group of subjects with acute exacerbation of schizophrenia using an asenapine flexible dosing design 5 or 10 mg BID will mimic actual clinical practice in a long-term 52-week 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 |
|---|---|---|---|
| 41513 | None | None | None |
| Hera | None | None | None |