Patients must meet diagnostic criteria for schizophrenia, persistent delusional disorder, acute and transient psychotic disorders, induced delusional disorders, schizoaffective disorders, other non-organic psychotic disorders or unspecified non-organic psychosis (ICD-10: F20.x; F22.x; F23.x; F24.x; F25.x; F28; F29)
Conditions
Brief summary
Change in Pre-pulse Inhibition of the Startle Reflex (PPI) in schizophrenia spectrum patients following exposure to GT-002, placebo, or oxazepam. The primary analysis will assess the difference between 2 mg GT-002 and placebo.
Detailed description
Changes in the Mismatch Negativity (MMN) paradigm, Selective Attention (SA) paradigm, 40-Hz Auditory Steady-State Response (40-Hz ASSR) paradigm, and frequency bands at resting state in schizophrenia spectrum patients following exposure to GT-002, oxazepam, or placebo., Safety and tolerability in both antipsychotic-treated schizophrenia spectrum patients and healthy controls, as measured by reported adverse events (AEs) and visual analogue mood scales (VAMS)., Changes in the EEG paradigms due to the differential acute effects between GT-002, oxazepam, and placebo in healthy controls., Changes in cognition due to GT-002 compared to oxazepam and placebo in both schizophrenia spectrum patients and healthy controls., The impact of antipsychotic medication type and its duration, sex, age, diagnosis, and duration of illness (DOI) on the acute effect of GT-002 on the EEG paradigms in schizophrenia spectrum patients.
Interventions
DRUGPlacebo for GT-002: a placebo soft gelatine capsule that is identical to the 1 mg gt-002 soft gelatine capsule and contains no active drug substance.
DRUGGT-002
DRUGOxazepam "Alternova"
DRUGtabletter
DRUGPlacebo for oxazepam: a placebo tablet containing no active drug substance
DRUGencapsulated to resemble the appearance of the encapsulated oxazepam tablet.
Sponsors
Region Hovedstadens Psykiatriske
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Pre-pulse Inhibition of the Startle Reflex (PPI) in schizophrenia spectrum patients following exposure to GT-002, placebo, or oxazepam. The primary analysis will assess the difference between 2 mg GT-002 and placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the Mismatch Negativity (MMN) paradigm, Selective Attention (SA) paradigm, 40-Hz Auditory Steady-State Response (40-Hz ASSR) paradigm, and frequency bands at resting state in schizophrenia spectrum patients following exposure to GT-002, oxazepam, or placebo., Safety and tolerability in both antipsychotic-treated schizophrenia spectrum patients and healthy controls, as measured by reported adverse events (AEs) and visual analogue mood scales (VAMS)., Changes in the EEG paradigms due to the differential acute effects between GT-002, oxazepam, and placebo in healthy controls., Changes in cognition due to GT-002 compared to oxazepam and placebo in both schizophrenia spectrum patients and healthy controls., The impact of antipsychotic medication type and its duration, sex, age, diagnosis, and duration of illness (DOI) on the acute effect of GT-002 on the EEG paradigms in schizophrenia spectrum patients. | — |
Countries
Denmark
Outcome results
None listed