Efficacy and Safety of Asenapine With Placebo and Haloperidol (41023)(COMPLETED)
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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.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Asenapine Drug: Haloperidol Other: Placebo arm |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- Improvement in schizophrenia (change in total PANSS score) from baseline to endpoint (LOCF/MMRM) [ Time Frame: Primary outcome measured weekly for 6 weeks ] [ Designated as safety issue: No ]
- Other dimensions of schizophrenia (positive, negative, disorganized thought, hostility/excitement, anxiety/depression, and general psychopathology) CGI-S; CGI-I [ Time Frame: At weekly intervals throughout the 6-week trial. ] [ Designated as safety issue: Yes ]
- Neurocognition and cognitive functioning [ Time Frame: Baseline and Endpoint ( Day 42) ] [ Designated as safety issue: Yes ]
- CDSS [ Time Frame: Days 21 and 42(Endpoint). ] [ Designated as safety issue: Yes ]
- Suicidal thinking ( ISST modified) [ Time Frame: Days 14 and 42 (Endpoint) ] [ Designated as safety issue: Yes ]
- Quality of life and patient functionality (QLS; Q-LES-Q ;PETIT0; Physical exam; Pregnancy test [ Time Frame: Baseline and Day 42(Endpoint) ] [ Designated as safety issue: Yes ]
- Readiness to discharge [ Time Frame: At weekly intervals during the 6-week trial ] [ Designated as safety issue: Yes ]
- EPS ( AIMS; BARS; SARS) [ Time Frame: At weekly intervals during the 6-week triaL ] [ Designated as safety issue: No ]
- Labs; Vital Signs; Weight and girth; ECG [ Time Frame: Days 14; 28 and 42 (Endpoint) ] [ Designated as safety issue: Yes ]
- Safety and Tolerability [ Designated as safety issue: Yes ]
| Enrollment: | 460 |
| Study Start Date: | July 2005 |
| Study Completion Date: | October 2006 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Asenapine 5 mg BID
|
Drug: Asenapine
5 mg BID
|
|
Experimental: 2
Asenapine 10 mg BID
|
Drug: Asenapine
10 mg BID
|
|
Active Comparator: 3
Haloperidol 4m mg BID
|
Drug: Haloperidol
4 mg BID
|
|
Placebo Comparator: 4
placebo
|
Other: Placebo arm |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Currently suffering from an acute exacerbation of schizophrenia. Caregiver required.
Exclusion Criteria:
- Have an uncontrolled, unstable medical condition. Have any other pyschiatric disorder other than schizophrenia as a primary diagnosis.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Study Director, NV Organon, part of Schering-Plough Corporation |
| ClinicalTrials.gov Identifier: | NCT00156104 History of Changes |
| Other Study ID Numbers: | 41023, Hera |
| Study First Received: | September 7, 2005 |
| Last Updated: | August 18, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Haloperidol Haloperidol decanoate Asenapine Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Gastrointestinal Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents |
ClinicalTrials.gov processed this record on June 17, 2013