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Sponsored by: |
Organon |
---|---|
Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00156104 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
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 |
---|---|
1: Experimental
Asenapine 5 mg BID
|
Drug: Asenapine
5 mg BID
|
2: Experimental
Asenapine 10 mg BID
|
Drug: Asenapine
10 mg BID
|
3: Active Comparator
Haloperidol 4m mg BID
|
Drug: Haloperidol
4 mg BID
|
4: Placebo Comparator
placebo
|
Other: Placebo arm |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | NV Organon, part of Schering-Plough Corporation ( Study Director ) |
Study ID Numbers: | 41023, Hera |
Study First Received: | September 7, 2005 |
Last Updated: | August 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00156104 |
Health Authority: | United States: Food and Drug Administration |
Haloperidol Schizophrenia Haloperidol decanoate Dopamine |
Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants |
Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |