A Multicenter, Randomized, Double-Blind, Fixed-Dose, 6-Week Trial of the Efficacy and Safety of Asenapine Compared With Placebo Using Olanzapine Positive Control in Subjects With an Acute Exacerbation of Schizophrenia
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 417
- Primary Endpoint
- Change in total PANSS score at endpoint (6-week double-blind or last assessment after baseline) from baseline
Study 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 imbalance in dopamine and serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that complete this trial will have the option of continuing in an additional one year extension trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- 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 psychiatric disorder other than schizophrenia as a primary diagnosis.
Arms & Interventions
1
asenapine 5 mg BID and 10 mg BID
Intervention: asenapine (Drug)
2
Placebo against olanzapine and asenapine
Intervention: Placebo (Drug)
3
olanzapine 15 mgQD
Intervention: olanzapine (Drug)
Outcomes
Primary Outcomes
Change in total PANSS score at endpoint (6-week double-blind or last assessment after baseline) from baseline
Time Frame: Screen, baseline, Days 4,7,14,21,28,35,42
Secondary Outcomes
- Anxiety(Baseline, day 42)
- Suicidal thinking(Baseline, day 42)
- Changes in PANSS subscale and Marder factor scores; CGI-S scores(Screen, baseline, Days 4,7,14,21,28,35,42)
- Neurocognition and cognitive functioning(Baseline , day 42)
- Readiness to discharge, at scheduled assessments and endpoint from baseline(Baseline up to day 14)
- Vital signs(Baseline, Days ,14,21,28,42)
- CGI-I scores(Days 4,7,14,21,28,35,42)
- Quality of life and patient functionality(Baseline, day 42)
- Weight(Baseline, Days 14,,28,,42)
- ECGs(Baseline, Days ,14,,28,,42)
- SAEs up to 30 days after endpoint(Screen, baseline, Days 4,7,14,21,28,35,42 and are are recorded continuously for AEs up to 30 days after endpoint)
- Laboratory parameters(Baseline, Days 14,,28,,42)
- Extrapyramidal symptoms(Baseline, Days 4,7,14,21,28,35,42)
- Adverse events (including serious adverse events)(Screen, baseline, Days 4,7,14,21,28,35,42 and are are recorded continuously for AEs up to 7 days after endpoint)