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
Overview
- Phase
- Phase 3
- Intervention
- Asenapine
- Conditions
- Schizophrenia
- Sponsor
- Organon and Co
- Enrollment
- 460
- Primary Endpoint
- Improvement in schizophrenia (change in total PANSS score) from baseline to endpoint (LOCF/MMRM)
- Status
- Completed
- Last Updated
- last year
Overview
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 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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
1
Asenapine 5 mg BID
Intervention: Asenapine
2
Asenapine 10 mg BID
Intervention: Asenapine
3
Haloperidol 4m mg BID
Intervention: Haloperidol
4
placebo
Intervention: Placebo arm
Outcomes
Primary Outcomes
Improvement in schizophrenia (change in total PANSS score) from baseline to endpoint (LOCF/MMRM)
Time Frame: Primary outcome measured weekly for 6 weeks
Secondary Outcomes
- Safety and Tolerability
- Neurocognition and cognitive functioning(Baseline and Endpoint ( Day 42))
- CDSS(Days 21 and 42(Endpoint).)
- Suicidal thinking ( ISST modified)(Days 14 and 42 (Endpoint))
- Readiness to discharge(At weekly intervals during the 6-week trial)
- EPS ( AIMS; BARS; SARS)(At weekly intervals during the 6-week triaL)
- Other dimensions of schizophrenia (positive, negative, disorganized thought, hostility/excitement, anxiety/depression, and general psychopathology) CGI-S; CGI-I(At weekly intervals throughout the 6-week trial.)
- Quality of life and patient functionality (QLS; Q-LES-Q ;PETIT0; Physical exam; Pregnancy test(Baseline and Day 42(Endpoint))
- Labs; Vital Signs; Weight and girth; ECG(Days 14; 28 and 42 (Endpoint))