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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours after ingestion of lorazepam/placebo
Awards & highlights

GABAmech Trial 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.Check my eligibility
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.See study design
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.

GABAmech Trial 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.

GABAmech Trial 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

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

GABAmech 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
1,797 Previous Clinical Trials
6,377,824 Total Patients Enrolled
2 Trials studying Psychosis
77 Patients Enrolled for Psychosis
National Institute of Mental Health (NIMH)NIH
2,785 Previous Clinical Trials
2,689,123 Total Patients Enrolled
46 Trials studying Psychosis
10,487 Patients Enrolled for Psychosis
Stephan Taylor, MDPrincipal InvestigatorUniversity of Michigan
4 Previous Clinical Trials
135 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study open to those of a more advanced age?

"According to the inclusion criteria, potential participants must be aged between 16-60. For those younger than that age range, 415 medical studies are available; for people over 65 years of age there is a pool of 1337 clinical trials."

Answered by AI

Is there still an opportunity for enrollment in this research trial?

"This trial is actively enrolling individuals, according to the clinicaltrials.gov information portal. It was initially posted on January 16th 2020 and recently updated November 22nd 2022."

Answered by AI

How many participants are expected to join this research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical research is actively seeking participants and was published on the 16th of January 2020; most recently updated on November 22nd 2022. There are 232 patients required for the trial from a single site."

Answered by AI

Could I be a candidate for participation in this research?

"To be eligible for this scientific trial, patients must have a diagnosis of psychosis and fall within the age range of 16 to 60 years old. The team is looking for 232 participants in total."

Answered by AI

Is there a precedent for examining the effects of Lorazepam on brain function via fMRI?

"Currently, 6 clinical studies are being conducted to examine the effects of Lorazepam on fMRI. Amongst these trials, one is in its final phase while the rest remain in earlier stages. With 8 different medical sites across Toronto and Ontario leading research into this drug-imaging combination."

Answered by AI

Does the concurrent use of Lorazepam and fMRI pose any risks to individuals?

"Our internal assessment of the safety value for Lorazepam and fMRI is a 3, due to this being Phase 4 trials which have already been approved."

Answered by AI

What purposes are Lorazepam and fMRI typically employed for?

"Lorazepam and fMRI are both capable of treating pharmacological issues, muscle spasms, as well as certain syndromes."

Answered by AI

Who else is applying?

What state do they live in?
Texas
New York
Michigan
Other
How old are they?
18 - 65
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0
3+

Why did patients apply to this trial?

I’m looking for relief. I am trying to make extra money for college. Always looking fir help with my condition...
PatientReceived no prior treatments
Im looking for a way to help myself And others. I wanted help she doesn't want to help trying to find something to help with my depression.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Phone Call
Average response time
  • < 2 Days
Most responsive sites:
  1. University of Michigan: < 24 hours
Recent research and studies
clinicaltrials.govStudy
Multi-modal Assessment of Gamma-aminobutyric Acid (GABA) Function in Psychosis
Stephan F. Taylor 2020. "Multi-modal Assessment of Gamma-aminobutyric Acid (GABA) Function in Psychosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04004416.
All > Mental Illness > Bipolar Disorder
~38 spots leftby Feb 2025
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