BENITIONSClinical Trial Intelligence

Multi-modal Assessment of Gamma-aminobutyric Acid (GABA) Function in Psychosis

4상 완료 NCT04004416

대상 질환Schizophrenia, Bipolar Disorder, Healthy, Psychosis
임상 단계4상
스폰서University of Michigan
상태완료
참여자 수143 명
중재(약물)Placebo and fMRI, Lorazepam and fMRI
시작일2020년 1월 16일
완료일2025년 2월 28일
결과 공개일2026년 6월 17일

요약

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
Early Psychosis Patients - Lorazepam 0.02 mg/kg-0.037 ± 0.138 AU
Early Psychosis Patients - Placebo-0.177 ± 0.209 AU
Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.01 mg/kg-0.167 ± 0.12 AU
Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.02 mg/kg-0.046 ± 0.169 AU
Schizophrenia or Schizoaffective Disorder Patients - Placebo-0.175 ± 0.207 AU
p-value0.938
F-Value (Estimation of Variance).136

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