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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 belowSelect...
I am not on long-term use of narcotics, barbiturates, or benzodiazepines.
Select...
My symptoms started less than 2 years ago.
Select...
I am between 16 and 35 years old.
Select...
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:Select...
I have had a serious head injury in the past.
Select...
I do not have a serious brain condition or liver failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 hours after ingestion of lorazepam/placebo
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours after ingestion of lorazepam/placebo
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
1,862 Previous Clinical Trials
6,441,235 Total Patients Enrolled
2 Trials studying Psychosis
77 Patients Enrolled for Psychosis
National Institute of Mental Health (NIMH)NIH
2,933 Previous Clinical Trials
2,745,806 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have not had thoughts or plans to harm yourself, as evaluated by a special questionnaire called the Columbia-Suicide Severity Rating Scale (C-SSRS).You are comfortable being in small, enclosed spaces without feeling anxious.I am not on long-term use of narcotics, barbiturates, or benzodiazepines.I haven't changed my mental health meds in the last 4 weeks and don't take antipsychotics.My symptoms started less than 2 years ago.I haven't changed my mental health meds in the last month and don't regularly take antipsychotics.I am between 16 and 35 years old.I have had a serious head injury in the past.I do not have a serious brain condition or liver failure.I am not pregnant nor trying to conceive.I have been diagnosed with a psychotic disorder or have had psychotic symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Controls
- Group 2: Bipolar disorder patients
- Group 3: Schizophrenia or Schizoaffective disorder patients
- Group 4: Early Psychosis patients
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Psychosis Patient Testimony for trial: Trial Name: NCT04004416 — Phase 4