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NCT04004416 · ClinicalTrials.gov registry record · Phase 4
Multi-modal Assessment of Gamma-aminobutyric Acid (GABA) Function in Psychosis
A Phase 4 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 4
- Development phase
- 143
- Enrollment target
NCT04004416: Completed Phase 4 study, sponsored by University of Michigan.
NCT04004416 is a Phase 4 study that has completed, run by University of Michigan. The registered enrollment target is 143 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04004416, a Phase 4 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 143 participants
- Enrollment target
Study 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.
Primary Outcome
Change in brain activity in the medial frontal cortex after being given lorazepam, a medication that changes the activity of GABAergic neurons. Results reflect the difference/change in brain signal between the lorazepam scan and the placebo scan. BOLD change in the dorsomedial prefrontal cortex (dmPFC) was summarized using MATLAB (MatrixLaboratory)'s SPM (Statistical Parametric Mapping) package for eigenvariate extraction, which extracts the first principal component of the voxel time series wit
Interventions
- OTHER Placebo and fMRI
- DRUG Lorazepam and fMRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2020-01-16 |
| Est. Completion | 2025-02-28 |
| Phase | Phase 4 |
What the finished NCT04004416 record still lists
NCT04004416 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo and fMRI is the first listed.
NCT04004416 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04004416 about?
NCT04004416 is a clinical study titled "Multi-modal Assessment of Gamma-aminobutyric Acid (GABA) Function in Psychosis". 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...
What is the current status of trial NCT04004416?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 143 participants. The study started on 2020-01-16. Estimated completion is 2025-02-28.
What interventions are being tested in trial NCT04004416?
The interventions under investigation include: Placebo and fMRI (OTHER), Lorazepam and fMRI (DRUG).
Who is sponsoring clinical trial NCT04004416?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04004416's enrollment target sits among peer trials
143 580th of 2000 higher than 1,421 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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