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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 is a Phase 4 study that has completed, run by University of Michigan. The registered enrollment target is 143 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04004416
The ClinicalTrials.gov registry entry for NCT04004416 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo and fMRI is the first listed.
NCT04004416 reports 0 study locations.
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.
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