Schizophrenia
Conditions
Keywords
Talnetant, schizophrenia, NK3 receptor antagonist, psychosis
Brief summary
A Placebo Controlled Study For Patients With Schizophrenia
Interventions
DRUGtalnetant
DRUGrisperidone
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient must meet diagnostic criteria for schizophrenia.
Exclusion criteria
* Patients with other psychotic disorders. * Patients whose condition is due to the direct physiological effects of a substances (e.g., drug abuse) or a general medical condition. * Patients with a history of autistic disorder or another pervasive developmental disorder. * Patients with epilepsy or a history of seizures requiring treatment. * Patients who are excluded from taking the drug risperidone. * Patients who pose a current serious suicidal or homicidal risk. * Patients who are adequately stabilized on their treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the PANSS total score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary measures assessed efficacy, safety & tolerability endpoints using the PANSS, BPRS Psychosis score, CGI-S, CGI-GI, Calgary Depression Scale for Schizophrenia, Brief Assessment of Cognition for Schizophrenia, and others. | — |
Countries
United States
Outcome results
None listed