Long-Term Efficacy and Safety of Asenapine Using Olanzapine as a Positive Control (41512)(COMPLETED)(P05784)
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Purpose
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 i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., 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 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Olanzapine Drug: Asenapine Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Flexible-Dose, Long-Term Extension Trial of the Safety and Maintenance of Effect of Asenapine Using Olanzapine Positive Control in Subjects Who Complete Protocols 041021 or 041022. |
- To assess long-term safety including overall symptoms (AEs; SAEs); Vital signs; ISST; EPS; and maintenance of effect; for asenapine with haloperidol control. [ Time Frame: Weeks 1;2; 4; 8; 12; 16; 24; 32; 40; 52 (Endpoint) ] [ Designated as safety issue: Yes ]
- Quality of Life and Patient Functionality (QLS; Q-LES-Q and PETIT) [ Time Frame: Weeks 16; 32; 52(Endpoint) ] [ Designated as safety issue: No ]
- Pregnancy tests; Lab tests [ Time Frame: Weeks 8; 16; 32; 52 (Endpoint) ] [ Designated as safety issue: Yes ]
- Physical exams [ Time Frame: Week 12; 24; 52 (Endpoint) ] [ Designated as safety issue: Yes ]
- Neurocognition and cognitive functioning [ Time Frame: Weeks 24 and 52 (Endpoint) ] [ Designated as safety issue: Yes ]
- Weight and abdominal girth [ Time Frame: Weeks 4;8;12; 16; 24; 32;40;52(Endpoint) ] [ Designated as safety issue: Yes ]
- ECGs [ Time Frame: Weeks 2;4;8;24;52(Endpoint) ] [ Designated as safety issue: Yes ]
- Depression (CDSS) [ Time Frame: Weeks 12; 24; 52 (Endpoint) ] [ Designated as safety issue: Yes ]
| Enrollment: | 260 |
| Study Start Date: | April 2005 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Olanzapine 20 mg QD
|
Drug: Olanzapine
5- 20 mg QD
|
|
Experimental: 2
Asenapine 5 or 10 mg BID
|
Drug: Asenapine
5 or 10 mg BID
|
|
3
Double-Blind subjects randomized to only placebo medication for 6 weeks in the short-term 041021 or 041022 asenapine trials, were randomized (double-blind) Into the long-term 041512 asenapine extension trial and received asenapine 5 mg BID for Week 1. After Week 1, subjects received asenapine (either 5 mg BID or 10 mg BID) for the remainder of the 52 week trial.
|
Other: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Completed the short-term trial ( 041021 or 021022)
- Continued to meet all demographic and procedural inclusion criteria of the short-term trial upon entry into this long-term extension trial
- Sign a written informed consent for the 041512 trial.
- Demonstrated an acceptable degree of compliance with trial medication in the short-term trials in the opinion of the investigator
Exclusion Criteria:
- CGI-S score of greater or equal to 6 ( severely psychotic)
- Occurrence(s) of AE or other clinically significant findings that would prohibit their continuation
- Met any of exclusion criteria regarding medical/psychiatric status listed in the short-term trials ( 041021 or 041022)
- Met exclusion criteria for medication status in short-term trials except for antidepressants and mood stabilizers.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00156091 History of Changes |
| Other Study ID Numbers: | 41512, Hera;, P05784 |
| Study First Received: | September 8, 2005 |
| Last Updated: | October 2, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Olanzapine Asenapine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 18, 2013