Multi-modal Assessment of Gamma-aminobutyric Acid (GABA) Function in Psychosis
Phase 4
Completed
NCT04004416
| Condition | Schizophrenia, Bipolar Disorder, Healthy, Psychosis |
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| Phase | Phase 4 |
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| Sponsor | University of Michigan |
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| Status | Completed |
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| Enrollment | 143 participants |
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| Interventions | Placebo and fMRI, Lorazepam and fMRI |
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| Start date | Jan 16, 2020 |
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| Completion date | Feb 28, 2025 |
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| Results posted | Jun 17, 2026 |
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Summary
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 |
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| F-Value (Estimation of Variance) | .136 |
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Open in BENITIONS
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