What side effects are associated with this type of intervention?

Benzodiazepines, such as Lorazepam, are commonly used to treat anxiety disorders by enhancing GABAergic neurotransmission. Known side effects include drowsiness, dizziness, impaired coordination, cognitive impairment, and memory issues. Long-term use can lead to dependence, tolerance, and withdrawal symptoms. There is also a risk of respiratory depression, particularly when used with other central nervous system depressants.

What prior FDA approvals exist?

Between 1985 and 2000, the FDA approved several anxiolytics for the treatment of anxiety disorders. These include benzodiazepines like Lorazepam, which enhance GABAergic neurotransmission to exert their anxiolytic effects. Other benzodiazepines approved during this period include Alprazolam and Clonazepam. Additionally, SSRIs and SNRIs, such as Sertraline and Duloxetine, have also been approved and are commonly used for anxiety disorders due to their efficacy and safety profile.

What other types of research exist?

Promising novel alternatives to Lorazepam for anxiety disorders include CGS 9896, a non-benzodiazepine compound that increases exploratory behavior in mice without sedative effects, and CL 218,872, a putative anxiolytic that has shown efficacy in animal models. These alternatives may offer effective anxiety relief with potentially fewer side effects.

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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

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 hours after single session placebo administration, an average of 1-5 weeks after enrollment (placebo could be session 1 or session 2) for reporting.

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 • NCT03090620

11%

Vomitnig

11%

Oversedation

100%

80%

60%

40%

20%

Study treatment Arm

Physostigmine

Lorazepam

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

Do I qualify?Apply below to find out

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.

Find a Location

Who is running the clinical trial?

Laureate Institute for Brain Research, Inc.Lead Sponsor

52 Previous Clinical Trials

5,275 Total Patients Enrolled

6 Trials studying Anxiety Disorders

483 Patients Enrolled for Anxiety Disorders

National Institute of Mental Health (NIMH)NIH

2,869 Previous Clinical Trials

2,777,371 Total Patients Enrolled

162 Trials studying Anxiety Disorders

68,483 Patients Enrolled for Anxiety Disorders

California Institute of TechnologyOTHER

14 Previous Clinical Trials

3,054 Total Patients Enrolled

~110 spots leftby Apr 2027

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