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

NCT04004416 PHASE4 COMPLETED

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). The study will also enroll eligible participants 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 will be two separate functional magnetic resonance imaging (fMRI) sessions in which lorazepam or placebo will be given prior to the MRI. During the fMRI the participants will also be asked to answer questions. Additionally, the participants will have their blood drawn, women of child bearing potential will have a urine pregnancy test, vital signs taken, and asked to complete more qols.

Details

Lead sponsor	University of Michigan
Phase	PHASE4
Status	COMPLETED
Enrolment	143
Start date	Thu Jan 16 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Feb 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Schizophrenia
• Bipolar Disorder
• Healthy
• Psychosis
• Schizophreniform Disorders
• Schizo Affective Disorder
• Major Depression With Psychotic Features

Interventions

• Placebo and fMRI
• Lorazepam and fMRI

Countries

United States