143 Participants Needed

Lorazepam for Psychosis

(GABAmech Trial)

PB
LM
CS
GS
AA
Overseen ByAml Almamri, BS
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Yes, Lorazepam is considered promising for treating psychosis, especially for controlling acute agitation and catatonia, which are symptoms of psychosis.126710

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

ST

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

Not currently on an involuntary treatment order
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.
See 12 more

Exclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1-2 visits (in-person or virtual)

Initial Assessment

Diagnostic interview and questionnaires to assess eligibility, may include videoconference

1 week
1-2 visits (in-person or virtual)

fMRI Sessions

Two fMRI sessions with lorazepam or placebo administration, including blood draw and questionnaires

2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after fMRI sessions

1 week

Treatment Details

Interventions

  • Blood Draw
  • fMRI
  • Lorazepam
  • Placebo
  • Pregnancy Test
Trial Overview 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.
Participant Groups
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

Lorazepam is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Ativan for:
  • Anxiety disorders
  • Short-term relief of anxiety symptoms
  • Preoperative sedation
🇪🇺
Approved in European Union as Ativan for:
  • Anxiety disorders
  • Insomnia
  • Preoperative sedation
🇨🇦
Approved in Canada as Ativan for:
  • 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

Trials
1,891
Recruited
6,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Findings from Research

High-frequency benzodiazepines like lorazepam and clonazepam are effective in managing acute psychotic agitation and catatonia, providing rapid control of symptoms in patients experiencing severe psychosis.
Alprazolam may be particularly beneficial for chronic schizophrenics with neuroleptic-resistant symptoms and depressive psychosis, while clonazepam is suggested for manic psychosis, highlighting the distinct roles these medications can play in treatment.
Emerging uses for high-potency benzodiazepines in psychotic disorders.Bodkin, JA.[2013]
Lorazepam has been evaluated for its effectiveness as a sedative in 36 severely ill patients, showing predictable and even sedation, which is beneficial for patient care in intensive care settings.
The study highlights that lorazepam does not accumulate in the body like diazepam, suggesting it may be a safer option for sedation in patients on ventilation or breathing spontaneously.
Lorazepam in intensive care.Simpson, PJ., Eltringham, RJ.[2013]
In a study involving 162 patients with acute psychotic agitation, oral treatment with risperidone and lorazepam was found to be as effective as the standard intramuscular treatment with haloperidol and lorazepam for rapidly controlling agitation.
Both treatment methods showed significant improvements in agitation scores at 30, 60, and 120 minutes, and were well tolerated, suggesting that the oral regimen could be a viable alternative to intramuscular administration.
Acute treatment of psychotic agitation: a randomized comparison of oral treatment with risperidone and lorazepam versus intramuscular treatment with haloperidol and lorazepam.Currier, GW., Chou, JC., Feifel, D., et al.[2013]

References

Emerging uses for high-potency benzodiazepines in psychotic disorders. [2013]
Lorazepam in intensive care. [2013]
Acute treatment of psychotic agitation: a randomized comparison of oral treatment with risperidone and lorazepam versus intramuscular treatment with haloperidol and lorazepam. [2013]
Haloperidol and lorazepam combined: clinical effects and drug plasma levels in the treatment of acute schizophrenic psychosis. [2013]
A double-blind study of lorazepam versus the combination of haloperidol and lorazepam in managing agitation. [2013]
Surge of Midazolam Use in the Midst of Lorazepam Shortage. [2023]
[Use of injectable lorazepam in status epilepticus: a comparative study in French-speaking hospitals]. [2015]
Lorazepam and driving impairment. [2019]
Intravenous lorazepam as an amnestic and anxiolytic agent in the intensive care unit: a prospective study. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
A randomized, double-blind comparison of lorazepam and chlordiazepoxide in patients with uncomplicated alcohol withdrawal. [2022]
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