In short
Clinical trials are investigating GT-002 in people with schizophrenia spectrum disorders. The TOTEMS study is looking at short-term effects on brain and body response measures, including signs linked to cognitive problems. It aims to compare GT-002 with placebo and oxazepam in adults who meet specific psychosis-related diagnoses.
Key points
- GT-002 is being studied in a Phase 2 clinical trial called TOTEMS. The trial includes adults with schizophrenia spectrum and related psychotic disorders, such as schizophrenia and schizoaffective disorder. Researchers are comparing GT-002 with placebo and oxazepam. The main outcome is pre-pulse inhibition of the startle reflex, and the study also measures EEG and EMG responses. The planned enrollment is 50 participants.
Trial overview
The TOTEMS study is an interventional Phase 2 clinical trial of GT-002 in people with schizophrenia spectrum and related psychotic disorders. It is authorised and plans to enroll 50 participants.
The full trial title says it is studying the acute effects of partial GABA(A)-receptor modulation by GT-002 on psychophysiological measures in schizophrenia spectrum patients. In simple terms, the researchers are looking at short-term changes in brain and body response tests in this patient group.
Who can participate
The trial is for patients who 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.
These conditions are listed using ICD-10 codes F20.x, F22.x, F23.x, F24.x, F25.x, F28, and F29. ICD-10 is a standard medical coding system used to classify diagnoses.
What is being studied
The main goal is to study how GT-002 affects psychophysiological measures, which are tests that look at how the brain and body react together. The brief summary says these measures include event-related EEG, EMG, and resting-state EEG.
The study also focuses on cognitive impairment in schizophrenia, which means problems with thinking skills such as attention, memory, and processing information. The summary explains that the tested brain and body measures are proxy measures of hypofrontality, a term for reduced activity in the front part of the brain.
Endpoints and measures
The primary endpoint is the change in pre-pulse inhibition of the startle reflex, also called PPI, in schizophrenia spectrum patients after exposure to GT-002, placebo, or oxazepam. A primary endpoint is the main result the researchers want to measure.
The primary analysis will compare 2 mg GT-002 with placebo. This means the study will mainly look for differences between the active treatment and the inactive look-alike treatment.
Other measures include EEG, which records electrical activity in the brain, and EMG, which records muscle electrical activity. The trial also includes resting-state EEG, which is a brain test done while a person is not doing a task.
Trial design and treatment groups
This is an interventional study, so researchers give study treatments and compare the results across groups. The listed interventions are GT-002, oxazepam, placebo for oxazepam, and placebo for GT-002.
The trial uses placebo controls, which help show whether any changes are linked to the study treatment rather than to expectation or chance. Oxazepam is also included as a comparison treatment in the study design.
What the results may help show
This trial may help show whether GT-002 changes short-term brain and body response measures in people with schizophrenia spectrum disorders. Because the study is Phase 2, it is aimed at learning more about the treatment effect in a defined patient group rather than giving final proof of benefit.
The focus on PPI, EEG, EMG, and resting-state EEG shows that the researchers are trying to understand how GT-002 may affect measurable signs linked to thinking problems in schizophrenia. The trial data do not report results yet, so the main value of the study is in the questions it is designed to answer.