Table of contents
- Trial overview
- Who can participate
- What is being studied
- Endpoints and measures
- Trial design and treatment groups
- What the results may help show
Trial overview
The TOTEMS study is an interventional Phase 2 clinical trial of GT-002 in people with schizophrenia spectrum and related psychotic disorders.[1] It is authorised and plans to enroll 50 participants.[1]
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.[1] In simple terms, the researchers are looking at short-term changes in brain and body response tests in this patient group.[1]
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.[1]
These conditions are listed using ICD-10 codes F20.x, F22.x, F23.x, F24.x, F25.x, F28, and F29.[1] ICD-10 is a standard medical coding system used to classify diagnoses.[1]
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.[1] The brief summary says these measures include event-related EEG, EMG, and resting-state EEG.[1]
The study also focuses on cognitive impairment in schizophrenia, which means problems with thinking skills such as attention, memory, and processing information.[1] 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.[1]
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.[1] A primary endpoint is the main result the researchers want to measure.[1]
The primary analysis will compare 2 mg GT-002 with placebo.[1] This means the study will mainly look for differences between the active treatment and the inactive look-alike treatment.[1]
Other measures include EEG, which records electrical activity in the brain, and EMG, which records muscle electrical activity.[1] The trial also includes resting-state EEG, which is a brain test done while a person is not doing a task.[1]
Trial design and treatment groups
This is an interventional study, so researchers give study treatments and compare the results across groups.[1] The listed interventions are GT-002, oxazepam, placebo for oxazepam, and placebo for GT-002.[1]
The trial uses placebo controls, which help show whether any changes are linked to the study treatment rather than to expectation or chance.[1] Oxazepam is also included as a comparison treatment in the study design.[1]
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.[1] 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.[1]
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.[1] The trial data do not report results yet, so the main value of the study is in the questions it is designed to answer.[1]
