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Benzodiazepine
Lorazepam for Depression and Anxiety
Phase 4
Recruiting
Led By Maria Ironside, DPhil
Research Sponsored by Laureate Institute for Brain Research, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-2 hours after single session drug administration, after both lorazepam and sessions have been completed, an average of 5 weeks after enrollment
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial uses Lorazepam, an anti-anxiety medication, to study how people with depression, anxiety, or both react to threats. The study aims to see if these groups process threats differently and how they respond to the medication. Lorazepam helps calm the brain, and the scans show which areas are involved in threat processing. Lorazepam has been used in various studies to treat anxiety and has shown effectiveness in improving emotional states in patients with anxiety.
Who is the study for?
This trial is for individuals with major depressive disorder (MDD) and/or an anxiety disorder. Participants must be fluent in English, have normal vision/hearing, and not be pregnant or planning pregnancy soon. They should not have a history of certain mental health disorders like schizophrenia or bipolar disorder, no recent medication changes, and no MRI contraindications.
What is being tested?
The study tests the effects of Lorazepam versus a placebo on threat sensitivity in people with depression alone, anxiety alone, or both. It involves brain imaging to observe how different groups respond to threats after taking the drug or placebo in two sessions totaling about 10.5 hours.
What are the potential side effects?
Lorazepam may cause drowsiness, dizziness, tiredness, blurred vision, unsteadiness; less common are confusion, depression, headache or slurred speech. Side effects can vary based on individual reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-2 hours after single session placebo administration, an average of 1-5 weeks after enrollment (placebo could be session 1 or session 2)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 hours after single session placebo administration, an average of 1-5 weeks after enrollment (placebo could be session 1 or session 2)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Eyeblink startle magnitude under threat in AD-MDD compared to MDD.
Secondary study objectives
Magnitude of blood oxygenated level dependent (BOLD) response to threat in AD-MDD compared to MDD.
The effect of Lorazepam on eyeblink startle magnitude and BOLD response to threat in AD-MDD compared to MDD
Side effects data
From 2020 Phase 4 trial • 19 Patients • NCT0309062011%
Vomitnig
11%
Oversedation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Physostigmine
Lorazepam
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LorazepamExperimental Treatment1 Intervention
Participants will receive a single 1mg dose of Lorazepam, to be taken orally under registered nurse (RN) supervision
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive a single dose of placebo, to be taken orally under RN supervision
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lorazepam
2009
Completed Phase 4
~2660
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for anxiety disorders include benzodiazepines like Lorazepam, which enhance GABAergic neurotransmission by increasing the effect of the neurotransmitter GABA, leading to a calming effect on the brain. This is crucial for patients as it helps reduce the excessive neural activity associated with anxiety.
Additionally, SSRIs and SNRIs, which increase the levels of serotonin and norepinephrine in the brain, respectively, are also commonly used. These medications help improve mood and reduce anxiety by enhancing neurotransmitter activity in brain circuits involved in mood regulation.
Understanding these mechanisms is important for patients as it helps them appreciate how these treatments work to alleviate their symptoms and the potential side effects associated with altering neurotransmitter levels.
Advances in pharmacotherapy for pediatric anxiety disorders.
Advances in pharmacotherapy for pediatric anxiety disorders.
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Who is running the clinical trial?
Laureate Institute for Brain Research, Inc.Lead Sponsor
52 Previous Clinical Trials
5,275 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,908 Previous Clinical Trials
2,738,918 Total Patients Enrolled
California Institute of TechnologyOTHER
15 Previous Clinical Trials
3,084 Total Patients Enrolled
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