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vabicaserin · 2 trials · 1 indication
PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.
PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | 4mg/day |
| 3 | PLACEBO_COMPARATOR | matching placebo |
| Name | Type | Description |
|---|---|---|
| vabicaserin | DRUG | This study will utilize a randomized, double-blind, placebo-controlled, comparator-referenced, multicenter, parallel-group adaptive design with placebo, risperidone (4 mg/day), and up to 7 treatment arms of vabicaserin (50, 100, 150, 200, 300, 400 and 600 mg/day) over the course of the study |
| risperidone | DRUG | - |
| placebo | OTHER | - |
Inclusion Criteria: * Generally healthy, men and women, aged 18 to 65. * Hospitalization because of an acute exacerbation of schizophrenia with a diagnosis of schizophrenia established greater than 1 year. * Ability to remain hospitalized for the duration of the screening period and for 4 weeks of ...
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Vabicaserin is an investigational small molecule developed by Pfizer, Inc. (NYSE: PFE) for the treatment of schizophrenia. It is a psychiatric drug candidate that was studied in Phase 2 clinical development. Vabicaserin has not been approved by the FDA and remains an investigational agent rather than a marketed medicine.
Vabicaserin targets the serotonin receptors HTR2C, HTR2B, and HTR2A, acting as an agonist at these targets. Its receptor activity profile distinguishes it from many other antipsychotic candidates, which often act through blockade rather than agonism at serotonin receptors.
Pfizer, Inc. (NYSE: PFE) developed vabicaserin. The company sponsored the clinical studies of the compound in schizophrenia, including a Phase 2 efficacy trial and a Phase 1 bioavailability study. Pfizer holds the development program for this investigational psychiatric drug candidate.
Vabicaserin reached Phase 2 clinical development for schizophrenia. It is an investigational drug and is not FDA approved. Both of its recorded trials are completed, and no trials are currently active, so the program is not presently advancing in clinical study.
Vabicaserin was studied in two completed trials. NCT00563706 was a Phase 2 placebo-controlled, randomized, double-blind study of vabicaserin in 199 male subjects with schizophrenia in the United States and Canada. NCT00541996 was a Phase 1 bioavailability study comparing oral formulations in healthy male volunteers in the United States.
No. Vabicaserin trials did not use biomarker-based patient selection. The Phase 2 schizophrenia study enrolled patients based on a clinical diagnosis rather than a molecular biomarker, and the program is not described as a biomarker-selected development effort.