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Acute Effects of Partial GABA(A)-Receptor Modulation by GT-002 on Psychophysiological Measures: The TOTEMS Phase II Clinical Trial Targeting Cognitive Impairment Associated with Schizophrenia
EU CTIS ID: 2024-519389-28-00
What this study is testing
The overall objective of the TOTEMS clinical trial is to investigate the acute effects of partial GABA(A)-receptor modulation by GT-002 on psychophysiological measures in schizophrenia spectrum patients, including event-related EEG and EMG, as well as resting-state EEG. Collectively, these psychophysiological parameters provide proxy measures of hypofrontality, which is considered a key mechanism underlying cognitive impairment in schizophrenia.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- General inclusion criteria (for all participants): 1. Legally competent (in Danish: 'myndige og habile i retslig forstand').
- General inclusion criteria (for all participants): 2. Males or non-pregnant, non-lactating females aged between 18 and 45 years.
- Additional inclusion criteria for healthy controls: 1. No current or previous diagnosed mental disorder.
- 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.
- 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.
- 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.
You likely can't join if
- General exclusion criteria (for all participants): 1. Prior serious adverse reaction, hypersensitivity, or intolerance to benzodiazepines, GT-002, placebo, or their excipients.
- General exclusion criteria (for all participants): 10. Clinically relevant abnormalities on 12-lead ECG at the screening visit (as judged by the TOTEMS investigators).
- General exclusion criteria (for all participants): 11. Clinically relevant findings in laboratory samples at screening (as judged by the TOTEMS investigators).
- 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.
- General exclusion criteria (for all participants): 13. Positive results from urine drug tests.
- General exclusion criteria (for all participants): 14. Unwillingness to refrain from donating blood or blood products during the study
See the full eligibility criteria
Who can join
- General inclusion criteria (for all participants): 1. Legally competent (in Danish: 'myndige og habile i retslig forstand').
- General inclusion criteria (for all participants): 2. Males or non-pregnant, non-lactating females aged between 18 and 45 years.
- Additional inclusion criteria for healthy controls: 1. No current or previous diagnosed mental disorder.
- 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.
- 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.
- 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.
- 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).
What rules you out
- General exclusion criteria (for all participants): 1. Prior serious adverse reaction, hypersensitivity, or intolerance to benzodiazepines, GT-002, placebo, or their excipients.
- General exclusion criteria (for all participants): 10. Clinically relevant abnormalities on 12-lead ECG at the screening visit (as judged by the TOTEMS investigators).
- General exclusion criteria (for all participants): 11. Clinically relevant findings in laboratory samples at screening (as judged by the TOTEMS investigators).
- 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.
- General exclusion criteria (for all participants): 13. Positive results from urine drug tests.
- General exclusion criteria (for all participants): 14. Unwillingness to refrain from donating blood or blood products during the study
- 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.
- 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.
- 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.
- Additional exclusion criteria for patients: 2. Any previous or current coercive measure as per Danish legislation ('Lov om Tvang i Psykiatrien').
- Additional exclusion criteria for patients: 3. Electroconvulsive therapy (ECT) in the last three months.
- General exclusion criteria (for all participants): 2. Ongoing treatment with benzodiazepines (see also concomitant treatment/medication).
- General exclusion criteria (for all participants): 3. Severe (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.
- General exclusion criteria (for all participants): 4. Pregnancy (assessed by urine pregnancy test).
- General exclusion criteria (for all participants): 5. Lactation
- General exclusion criteria (for all participants): 6. Unwillingness 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.
- General exclusion criteria (for all participants): 7. Hearing impairment compromising the planned EEG assessments.
- General exclusion criteria (for all participants): 8. Physical or language impairments that negatively impact the accuracy of cognitive assessment data or verified mental retardation (IQ ≤ 70).
- General exclusion criteria (for all participants): 9. Clinically relevant findings on physical examination at the screening visit (as judged by the TOTEMS investigators).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.