NCT04004416已完成4 期
Multi-modal Assessment of GABA Function in Psychosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 2
- 主要终点
- Blood Oxygen level dependent (BOLD) in medial frontal cortex while viewing affective pictures
研究概览
简要总结
The purpose of this study is to better understand mental illness and will test the hypotheses that, while viewing affective stimuli, patient groups will show increased blood oxygenation level dependent (BOLD) signal by fMRI after lorazepam.
This study will enroll participants between the ages of 16 and 60, who have a psychotic illness (such as psychosis which includes conditions like schizophrenia, schizoaffective disorder, and mood disorders like bipolar disorder). The study will also enroll eligible participants between the ages of 18 and 60 without any psychiatric illness to compare their brains.
The study will require participants to have 3-4 sessions over a few weeks. The initial assessments (may be over two visits) will include a diagnostic interview and several questionnaires (qols) to assess eligibility. Subsequently, there will be two separate functional magnetic resonance imaging (fMRI) sessions in which lorazepam or placebo will be given prior to the fMRI. During the fMRI, the participants will also be asked to answer questions. Additionally, the participants will have their blood drawn, vital signs will be taken, they will be asked to complete more qols, and women of childbearing potential will have a urine pregnancy test.
详细描述
- Please note the collaborator (NIMH) is requesting that an NCT number be obtained prior to receiving the award number.
- Initial assessment(s) may be done via videoconference due to Covid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
盲法说明
Study coordinator and participant are blinded to medication administration.
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Early psychosis (EP) patients:
- •Inclusion Criteria:
- •Ability and willingness to give informed consent to participate;
- •16-35 years old
- •Meets DSM5 criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, bipolar disorder type 1, with history of psychosis, major depressive disorder, with history of psychosis, brief psychotic disorder, or other specified/unspecified psychotic disorder; or, meets SIPS criteria for Presence of Psychotic Symptoms or Brief Intermittent Psychotic Syndrome (BIPS).
- •Positive symptom onset ≤ 2 years
- •No history of active substance use disorder in the past 2 months
- •Not currently on an involuntary treatment order
- •Not taking chronic narcotics, barbiturates, benzodiazepines
- •Absence of suicidal thoughts with plans or intentions, as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
- •No increases in psychotropic medication within the prior 4 weeks reflecting clinical instability and for half of the EP sample, not taking antipsychotic medication within the prior 4 weeks. Patients may take as needed doses of benzodiazepines as clinically prescribed, as long as those doses are not required within 5 half-lives of an fMRI session
- •Ability to tolerate small, enclosed spaces without anxiety
- •Vision equal to or better than 20/40 on a Snellen chart, with correction if necessary
- •No metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition, e. g. aneurysm clips, retained particles (metal workers excluded), neurostimulators, foil-backed transdermal patches, carotid or cerebral stents, cerebral spinal fluid (CSF) shunts; magnetic dental implants, ferromagnetic ocular implants, pacemakers, automatic implantable defibrillators
- •Size compatible with scanner gantry, e. g. men over 6 feet tall that weigh more than 250 pounds (lbs), men under 6 feet tall that weigh over 220 lbs, women over 5'11" tall that weigh more than 220 lbs, or women under 5'10" tall that weigh more than 200 lbs. Subjects of these weights or greater typically have difficulty fitting into the fMRI scanner properly.
排除标准
- •If a woman of childbearing age, not pregnant or trying to become pregnant
- •History of serious neurological illness or current medical condition that could compromise brain function, such as liver failure
- •History of closed head injury, for example (e.g.) loss of consciousness > ~5 min, hospitalization, neurological sequela
- •Hypersensitivity to benzodiazepines or to components of the formulation, per judgment of the principal investigator (PI)
- •Disorders affected by benzodiazepines, such as compromised respiratory function, e.g., chronic obstructive pulmonary disease, or acute, narrow angle glaucoma, per judgment of the principal investigator (PI)
- •Schizophrenia/schizoaffective (SCZ) and bipolar affective disorder (BAD) patients:
- •Inclusion Criteria:
- •Ability and willingness to give informed consent to participate;
- •16- 60 years old
- •Meets DSM5 criteria for schizophrenia, schizoaffective disorder, other specified/unspecified psychotic disorder, or bipolar disorder type 1, with history of psychosis bipolar affective disorder
- •Duration of positive symptom onset > 2 years
- •No history of active substance use disorder in the past 2 months
- •Not currently on an involuntary treatment order
- •Not taking chronic narcotics, barbiturates, benzodiazepines
- •Absence of suicidal thoughts with plans or intentions, as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
- •No increases in psychotropic medication within the prior 4 weeks reflecting clinical instability. Patients may take as needed doses of benzodiazepines as clinically prescribed, as long as those doses are not required within 5 half-lives of an fMRI session
- •Ability to tolerate small, enclosed spaces without anxiety
- •Vision equal to or better than 20/40 on a Snellen chart, with correction if necessary
- •No metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition, e. g. aneurysm clips, retained particles (metal workers excluded), neurostimulators, foil-backed transdermal patches, carotid or cerebral stents, cerebral spinal fluid (CSF) shunts; magnetic dental implants, ferromagnetic ocular implants, pacemakers, automatic implantable defibrillators
- •Size compatible with scanner gantry, e. g. men over 6 feet tall that weigh more than 250 pounds (lbs), men under 6 feet tall that weigh over 220 lbs, women over 5'11" tall that weigh more than 220 lbs, or women under 5'10" tall that weigh more than 200 lbs. Subjects of these weights or greater typically have difficulty fitting into the fMRI scanner properly.
- •Exclusion Criteria:
- •If a woman of childbearing age, not pregnant or trying to become pregnant
- •History of serious neurological illness or current medical condition that could compromise brain function, such as liver failure
- •History of closed head injury, for example (e.g.) loss of consciousness > ~5 min, hospitalization, neurological sequela
- •Hypersensitivity to benzodiazepines or to components of the formulation, per judgment of the principal investigator (PI)
- •Disorders affected by benzodiazepines, such as compromised respiratory function, e.g., chronic obstructive pulmonary disease, or acute, narrow angle glaucoma, per judgment of the principal investigator (PI)
- •Healthy control subjects:
- •Inclusion Criteria:
- •Ability and willingness to give informed consent to participate
- •18- 60 years old
- •No history of (h/o) past or current mental illness (except for simple phobias), but prior h/o substance abuse okay if in remission for greater than 5 years
- •Not taking any medication, prescription or non-prescription, with psychotropic effects (birth control medications allowed)
- •No first-degree family members with a history of a psychotic disorder (including bipolar disorder)
- •Ability to tolerate small, enclosed spaces without anxiety
- •Vision equal to or better than 20/40 on a Snellen chart, with correction if necessary
- •No metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition, e. g. aneurysm clips, retained particles (metal workers excluded), neurostimulators, foil-backed transdermal patches, carotid or cerebral stents, cerebral spinal fluid (CSF) shunts; magnetic dental implants, ferromagnetic ocular implants, pacemakers, automatic implantable defibrillators
- •Size compatible with scanner gantry, e. g. men over 6 feet tall that weigh more than 250 pounds (lbs), men under 6 feet tall that weigh over 220 lbs, women over 5'11" tall that weigh more than 220 lbs, or women under 5'10" tall that weigh more than 200 lbs. Subjects of these weights or greater typically have difficulty fitting into the fMRI scanner properly.
- •Exclusion Criteria:
- •If a woman of childbearing age, not pregnant or trying to become pregnant
- •History of serious neurological illness or current medical condition that could compromise brain function, such as liver failure
- •History of closed head injury, for example (e.g.) loss of consciousness > ~5 min, hospitalization, neurological sequela
- •Hypersensitivity to benzodiazepines or to components of the formulation, per judgment of the principal investigator (PI)
- •Disorders affected by benzodiazepines, such as compromised respiratory function, e.g., chronic obstructive pulmonary disease, or acute, narrow angle glaucoma, per judgment of the principal investigator (PI)
研究组 & 干预措施
Healthy Controls
Placebo Comparator
干预措施: Placebo and fMRI (Other)
Bipolar disorder patients
Experimental
干预措施: Placebo and fMRI (Other)
Early Psychosis patients
Experimental
干预措施: Placebo and fMRI (Other)
Schizophrenia or Schizoaffective disorder patients
Experimental
干预措施: Placebo and fMRI (Other)
Healthy Controls
Placebo Comparator
干预措施: Lorazepam and fMRI (Drug)
Early Psychosis patients
Experimental
干预措施: Lorazepam and fMRI (Drug)
Bipolar disorder patients
Experimental
干预措施: Lorazepam and fMRI (Drug)
Schizophrenia or Schizoaffective disorder patients
Experimental
干预措施: Lorazepam and fMRI (Drug)
结局指标
主要结局
Blood Oxygen level dependent (BOLD) in medial frontal cortex while viewing affective pictures
时间窗: 2 hours after ingestion of lorazepam/placebo
BOLD signal change in medial frontal cortex after lorazepam challenge during fMRI
次要结局
未报告次要终点
研究者
Stephan F. Taylor
Professor of Psychiatry
University of Michigan
研究点 (2)
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