drugset / Trial / NCT04004416

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

NCT04004416

RandomizedCrossoverDouble-blindBasic science

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 childbearing potential will have a urine pregnancy test.

Timeline

Start
2020-01-16
Primary completion
2025-02-28
Completion
2025-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Lorazepam Small molecule 0.01 mg/kg
Subject Lorazepam Small molecule 0.02 mg/kg