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Benzodiazepine

Lorazepam for Psychosis (GABAmech Trial)

Phase 4
Recruiting
Led By Stephan Taylor, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Not taking chronic narcotics, barbiturates, benzodiazepines
Positive symptom onset ≤ 2 years
Must not have
History of closed head injury, for example (e.g.) loss of consciousness > ~5 min, hospitalization, neurological sequela
History of serious neurological illness or current medical condition that could compromise brain function, such as liver failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours after ingestion of lorazepam/placebo
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is testing if lorazepam affects blood oxygenation level dependent (BOLD) signal by fMRI after viewing affective stimuli in people with mental illness.

Who is the study for?
This trial is for individuals aged 16-35 with psychotic illnesses like schizophrenia or bipolar disorder, and healthy subjects to serve as a comparison. Participants must not have had substance use disorders recently, be willing to consent, able to handle small spaces without anxiety, and not on certain medications or involuntary treatment orders.
What is being tested?
The study tests how lorazepam affects brain function in people with psychosis by using fMRI scans while they view emotional stimuli. It compares the effects of lorazepam against a placebo over several sessions involving interviews, questionnaires, blood tests, and MRIs.
What are the potential side effects?
Lorazepam may cause drowsiness, dizziness, tiredness, blurred vision, unsteadiness. During an MRI scan some might feel discomfort due to the enclosed space or loud noises from the machine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not on long-term use of narcotics, barbiturates, or benzodiazepines.
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My symptoms started less than 2 years ago.
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I am between 16 and 35 years old.
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I have been diagnosed with a psychotic disorder or have had psychotic symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a serious head injury in the past.
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I do not have a serious brain condition or liver failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours after ingestion of lorazepam/placebo
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours after ingestion of lorazepam/placebo for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blood Oxygen level dependent (BOLD) in medial frontal cortex while viewing affective pictures

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Schizophrenia or Schizoaffective disorder patientsExperimental Treatment2 Interventions
Group II: Early Psychosis patientsExperimental Treatment2 Interventions
Group III: Bipolar disorder patientsExperimental Treatment2 Interventions
Group IV: Healthy ControlsPlacebo Group2 Interventions

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,856 Previous Clinical Trials
6,435,018 Total Patients Enrolled
2 Trials studying Psychosis
77 Patients Enrolled for Psychosis
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,940 Total Patients Enrolled
47 Trials studying Psychosis
10,561 Patients Enrolled for Psychosis
Stephan Taylor, MDPrincipal InvestigatorUniversity of Michigan
4 Previous Clinical Trials
139 Total Patients Enrolled

Media Library

Lorazepam (Benzodiazepine) Clinical Trial Eligibility Overview. Trial Name: NCT04004416 — Phase 4
Psychosis Research Study Groups: Healthy Controls, Bipolar disorder patients, Schizophrenia or Schizoaffective disorder patients, Early Psychosis patients
Psychosis Clinical Trial 2023: Lorazepam Highlights & Side Effects. Trial Name: NCT04004416 — Phase 4
Lorazepam (Benzodiazepine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04004416 — Phase 4
Psychosis Patient Testimony for trial: Trial Name: NCT04004416 — Phase 4
~11 spots leftby Feb 2025
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