NCT04004416

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

Multi-modal Assessment of GABA Function in Psychosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Accepted

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). 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.

Detailed description

* Please note the collaborator (NIMH) is requesting that an NCT number be obtained prior to receiving the award number. * Initial assessment(s) may be done via videoconference due to Covid.

Conditions

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

Interventions

Type	Name	Description
OTHER	Placebo and fMRI	A dose of Placebo will be given 90 minutes prior to entering the fMRI scanner. At each visit volunteers will complete assessments (vitals, qols) and optional blood draw prior to having an fMRI. Females may need to have this scheduled to coincide with a certain phase of their menstrual cycle. During the fMRI participants will be asked to view pleasant/unpleasant pictures and rate them while you are inside the scanner.
DRUG	Lorazepam and fMRI	A dose of Lorazepam (assigned to one of two dose levels between subjects: 0.01 mg/kg or 0.02 mg/kg) will be given 90 minutes prior to entering the fMRI scanner. At each visit volunteers will complete assessments (vitals, qols) and optional blood draw prior to having an fMRI. There will be two fMRIs done approximately 1 week apart and after the assessment visit. Females may need to have this scheduled to coincide with a certain phase of their menstrual cycle. During the fMRI participants will be asked to view pleasant/unpleasant pictures and rate them while you are inside the scanner.

Timeline

• Start date: 2020-01-16
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2019-07-02
• Last updated: 2025-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study