Lorazepam for Psychosis
(GABAmech Trial)
Trial Summary
Do I need to stop my current medications to join the trial?
The trial requires that you are not taking chronic narcotics, barbiturates, or benzodiazepines. You should not have increased your psychotropic medication in the last 4 weeks. You can take benzodiazepines as needed, but not within 5 half-lives of an MRI session. Healthy controls cannot take any medication with psychotropic effects.
What data supports the idea that Lorazepam for Psychosis is an effective drug?
The available research shows that lorazepam, when used alone, does not significantly improve symptoms of acute psychosis compared to other treatments. In one study, combining lorazepam with haloperidol did not lead to better outcomes than using haloperidol alone. Another study found that lorazepam is effective in controlling acute psychotic agitation, but it is not specifically effective in improving mood-related symptoms. Overall, the evidence suggests that lorazepam may help with agitation but is not particularly effective as a standalone treatment for psychosis.12345
What safety data is available for lorazepam treatment?
Safety data for lorazepam includes its use in intensive care for sedation, where it has been evaluated for cardiovascular and neurological effects. Common side effects include sedation, dizziness, weakness, unsteadiness, and disorientation, which can impair activities like driving. Lorazepam has been compared to diazepam for potential accumulation in the body. It is also used in managing anxiety, insomnia, and status epilepticus, with noted shortages leading to alternative treatments like midazolam.26789
Is the drug Lorazepam a promising treatment for psychosis?
What is the purpose of this trial?
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). The study will also enroll eligible participants 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 will be two separate functional magnetic resonance imaging (fMRI) sessions in which lorazepam or placebo will be given prior to the MRI. During the fMRI the participants will also be asked to answer questions. Additionally, the participants will have their blood drawn, women of child bearing potential will have a urine pregnancy test, vital signs taken, and asked to complete more qols.
Research Team
Stephan Taylor, MD
Principal Investigator
University of Michigan
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Assessment
Diagnostic interview and questionnaires to assess eligibility, may include videoconference
fMRI Sessions
Two fMRI sessions with lorazepam or placebo administration, including blood draw and questionnaires
Follow-up
Participants are monitored for safety and effectiveness after fMRI sessions
Treatment Details
Interventions
- Blood Draw
- fMRI
- Lorazepam
- Placebo
- Pregnancy Test
Lorazepam is already approved in United States, European Union, Canada for the following indications:
- Anxiety disorders
- Short-term relief of anxiety symptoms
- Preoperative sedation
- Anxiety disorders
- Insomnia
- Preoperative sedation
- Anxiety disorders
- Short-term relief of anxiety symptoms
- Preoperative sedation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator