Multi-modal Assessment of Gamma-aminobutyric Acid (GABA) Function in Psychosis
4期
已完成
NCT04004416
| 适应症 | Schizophrenia, Bipolar Disorder, Healthy, Psychosis |
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| 分期 | 4期 |
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| 申办方 | University of Michigan |
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| 状态 | 已完成 |
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| 受试者人数 | 143 人 |
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| 干预(药物) | Placebo and fMRI, Lorazepam and fMRI |
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| 开始日期 | 2020年1月16日 |
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| 完成日期 | 2025年2月28日 |
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| 结果公布日 | 2026年6月17日 |
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摘要
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 ch
Blood Oxygen Level Dependent (BOLD) Change in Medial Frontal Cortex While Viewing Affective Pictures
Approximately 28 days · AU
| Early Psychosis Patients - Lorazepam 0.01 mg/kg | -0.174 ± 0.183 AU |
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| Early Psychosis Patients - Lorazepam 0.02 mg/kg | -0.037 ± 0.138 AU |
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| Early Psychosis Patients - Placebo | -0.177 ± 0.209 AU |
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| Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.01 mg/kg | -0.167 ± 0.12 AU |
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| Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.02 mg/kg | -0.046 ± 0.169 AU |
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| Schizophrenia or Schizoaffective Disorder Patients - Placebo | -0.175 ± 0.207 AU |
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| p-value | 0.938 |
| F-Value (Estimation of Variance) | .136 |
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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。