2024-519389-28-00招募中2 期
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
Region Hovedstadens Psykiatriske1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年2月14日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •General inclusion criteria (for all participants):
- •Legally competent (in Danish: 'myndige og habile i retslig forstand').
- •General inclusion criteria (for all participants):
- •Males or non-pregnant, non-lactating females aged between 18 and 45 years.
- •Additional inclusion criteria for healthy controls:
- •No current or previous diagnosed mental disorder.
- •Additional inclusion criteria for healthy controls:
- •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:
- •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:
- •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:
- •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).
排除标准
- •General exclusion criteria (for all participants):
- •Prior serious adverse reaction, hypersensitivity, or intolerance to benzodiazepines, GT-002, placebo, or their excipients.
- •General exclusion criteria (for all participants):
- •Clinically relevant abnormalities on 12-lead ECG at the screening visit (as judged by the TOTEMS investigators).
- •General exclusion criteria (for all participants):
- •Clinically relevant findings in laboratory samples at screening (as judged by the TOTEMS investigators).
- •General exclusion criteria (for all participants):
- •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):
- •Positive results from urine drug tests.
- •General exclusion criteria (for all participants):
- •Unwillingness to refrain from donating blood or blood products during the study
- •Additional exclusion criteria for healthy controls:
- •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:
- •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:
- •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:
- •Any previous or current coercive measure as per Danish legislation ('Lov om Tvang i Psykiatrien').
- •Additional exclusion criteria for patients:
- •Electroconvulsive therapy (ECT) in the last three months.
- •General exclusion criteria (for all participants):
- •Ongoing treatment with benzodiazepines (see also concomitant treatment/medication).
- •General exclusion criteria (for all participants):
- •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):
- •Pregnancy (assessed by urine pregnancy test).
- •General exclusion criteria (for all participants):
- •General exclusion criteria (for all participants):
- •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):
- •Hearing impairment compromising the planned EEG assessments.
- •General exclusion criteria (for all participants):
- •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):
- •Clinically relevant findings on physical examination at the screening visit (as judged by the TOTEMS investigators).
结局指标
主要结局
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.
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.
次要结局
- 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.
研究者
Bjørn H. Ebdrup
Scientific
Region Hovedstadens Psykiatriske
研究点 (1)
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