Schizophrenia
Conditions
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.
Interventions
DRUGAsenapine
5 mg BID
DRUGHaloperidol
4 mg BID
OTHERPlacebo arm
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in schizophrenia (change in total PANSS score) from baseline to endpoint (LOCF/MMRM) | Primary outcome measured weekly for 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Neurocognition and cognitive functioning | Baseline and Endpoint ( Day 42) |
| CDSS | Days 21 and 42(Endpoint). |
| Suicidal thinking ( ISST modified) | Days 14 and 42 (Endpoint) |
| Quality of life and patient functionality (QLS; Q-LES-Q ;PETIT0; Physical exam; Pregnancy test | Baseline and Day 42(Endpoint) |
| 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. |
| EPS ( AIMS; BARS; SARS) | At weekly intervals during the 6-week triaL |
| Labs; Vital Signs; Weight and girth; ECG | Days 14; 28 and 42 (Endpoint) |
| Safety and Tolerability | — |
| Readiness to discharge | At weekly intervals during the 6-week trial |
Outcome results
None listed