GT-002 for Schizophrenia | Delusional disorder | Acute and transient psychotic disorder | Induced delusional disorder | Schizoaffective disorder | Other non-organic psychotic disorders | Unspecified non-organic psychosis

Inclusion criteria

• {"criterion_text":"- General inclusion criteria (for all participants): 1.\tLegally competent (in Danish: 'myndige og habile i retslig forstand').\n- General inclusion criteria (for all participants): 2.\tMales or non-pregnant, non-lactating females aged between 18 and 45 years.\n- Additional inclusion criteria for healthy controls: 1. No current or previous diagnosed mental disorder.\n- Additional inclusion criteria for healthy controls: 2. No first-degree relative with known major psychiatric disorder (ICD-10: F1x; F2x; F3x), defined as having received medical treatment for and/or hospitalizations related to these diagnoses.\n- Additional inclusion criteria for patients: 1. Fulfilling the 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), prioritizing patients with a shorter antipsychotic history.\n- Additional inclusion criteria for patients: 2. Treated with antipsychotic monotherapy for at least the last three months, including pro re nata (PRN) antipsychotic medication, and prioritizing patients treated specifically with dopamine receptor partial agonists, irrespective of formulation.\n- Additional inclusion criteria for patients: 3. Clinically stable for a minimum of the last three months, i.e., without hospitalizations for schizophrenia or recently intensified psychiatric care (as judged by the TOTEMS investigators)."}

Exclusion criteria

• {"criterion_text":"- General exclusion criteria (for all participants): 1.\tPrior serious adverse reaction, hypersensitivity, or intolerance to benzodiazepines, GT-002, placebo, or their excipients.\n- General exclusion criteria (for all participants): 10. Clinically relevant abnormalities on 12-lead ECG at the screening visit (as judged by the TOTEMS investigators).\n- General exclusion criteria (for all participants): 11. Clinically relevant findings in laboratory samples at screening (as judged by the TOTEMS investigators).\n- General exclusion criteria (for all participants): 12. Participation in a clinical study involving study medical treatment administration within three months prior to screening or in more than 2 clinical studies within 1 year prior to the screening visit.\n- General exclusion criteria (for all participants): 13. Positive results from urine drug tests.\n- General exclusion criteria (for all participants): 14. Unwillingness to refrain from donating blood or blood products during the study\n- Additional exclusion criteria for healthy controls: 1. Lifetime substance dependence (ICD-10: F1x.2) (exception: nicotine dependence, F17.x) or any use of illicit drugs within the 12 months prior to inclusion.\n- Additional exclusion criteria for healthy controls: 2. Any prescribed medications and over-the-counter medications (exceptions specified in the protocol) within 3 weeks prior to the first study drug administration.\n- Additional exclusion criteria for patients: 1. Current substance dependence (ICD-10 F1x.2) (exception: nicotine dependence, F17.x) or any use of illicit drugs within the three months prior to inclusion.\n- Additional exclusion criteria for patients: 2. Any previous or current coercive measure as per Danish legislation ('Lov om Tvang i Psykiatrien').\n- Additional exclusion criteria for patients: 3. Electroconvulsive therapy (ECT) in the last three months.\n- General exclusion criteria (for all participants): 2.\tOngoing treatment with benzodiazepines (see also concomitant treatment/medication).\n- General exclusion criteria (for all participants): 3.\tSevere (co-morbid) physical condition (as judged by the TOTEMS investigators), including but not limited to kidney disease, liver disease, chronic obstructive pulmonary disease (COPD), sleep apnea, hypotension, heart failure, and suicidal behavior.\n- General exclusion criteria (for all participants): 4.\tPregnancy (assessed by urine pregnancy test).\n- General exclusion criteria (for all participants): 5.\tLactation\n- General exclusion criteria (for all participants): 6.\tUnwillingness or inability to use contraception methods during the study period and until the end of the relevant systemic exposure period, defined as 5 days after the last study drug administration. This applies only to women of childbearing potential.\n- General exclusion criteria (for all participants): 7.\tHearing impairment compromising the planned EEG assessments.\n- General exclusion criteria (for all participants): 8.\tPhysical or language impairments that negatively impact the accuracy of cognitive assessment data or verified mental retardation (IQ ≤ 70).\n- General exclusion criteria (for all participants): 9.\tClinically relevant findings on physical examination at the screening visit (as judged by the TOTEMS investigators)."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Pre-pulse Inhibition (PPI) assessed using psychophysiological startle paradigms (proxy measures of hypofrontality using EEG/EMG measures); primary analysis compares 2 mg GT-002 versus placebo."}

Secondary endpoints

• {"endpoint_text":"- 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.\n- 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).\n- Changes in the EEG paradigms due to the differential acute effects between GT-002, oxazepam, and placebo in healthy controls.\n- Changes in cognition due to GT-002 compared to oxazepam and placebo in both schizophrenia spectrum patients and healthy controls.\n- 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.","definition_or_measurement_approach":"Secondary endpoints are measured using EEG paradigms (MMN, SA, 40-Hz ASSR, resting-state frequency bands), cognitive assessments, and safety measures (reported AEs and VAMS). Analyses include comparisons between GT-002, oxazepam and placebo and subgroup analyses by medication type/duration, sex, age, diagnosis and duration of illness."}

Methods

• Online recruitment material and adverts targeted to healthy volunteers (titles include 'Cirka 1000 anslag Raske', 'Cirka 2000 anslag Raske').
• Online recruitment material and adverts targeted to patients (titles include 'Cirka 1000 anslag Patienter', 'Cirka 2000 anslag Patienter').
• Trialtree.dk postings for healthy volunteers and patients ('Trialtree.dk Raske', 'Trialtree.dk Patienter').
• Research portal for patient inclusion ('Forskningsportal til patientinklusion Patienter').
• Kittel card / information cards for patients ('K2_ Recruitment material Kittelkort Patienter').

Denmark

Earliest CTIS Part Ii Submission Date

19-12-2024

Latest Decision Or Authorization Date

12-05-2026

Processing Time Days

509

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Region Hovedstadens Psykiatriske

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}