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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

Study Summary

This trial looks at how depression and anxiety affect brain function and response to drugs.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Eyeblink startle magnitude under threat in AD-MDD compared to MDD.

Secondary outcome measures

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

Find a Location

Who is running the clinical trial?

Laureate Institute for Brain Research, Inc.Lead Sponsor

50 Previous Clinical Trials

5,180 Total Patients Enrolled

6 Trials studying Anxiety Disorders

483 Patients Enrolled for Anxiety Disorders

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,544 Total Patients Enrolled

157 Trials studying Anxiety Disorders

65,223 Patients Enrolled for Anxiety Disorders

California Institute of TechnologyOTHER

13 Previous Clinical Trials

3,004 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is Lorazepam a hazard to human health?

"Thanks to the Phase 4 trial data, Lorazepam is judged as safe and received a score of 3."

Answered by AI

Could I partake in this experiment?

"To qualify for this medical research, prospective participants must be aged 18-65 and suffering from depression. A total of 165 individuals are being admitted to the trial."

Answered by AI

Does the age criteria for enrolment in this study extend below 35 years?

"This experiment is only open to those aged 18-65. However, there are 408 studies for minors and 1398 clinical trials specifically designed for patients who exceed the age of 65."

Answered by AI

Is this investigation still accommodating new participants?

"According to the information provided on clinicaltrials.gov, recruitment for this particular medical trial has concluded; it was initially posted on October 1st 2023 and last updated August 16th of the same year. However, 1985 other studies are actively seeking participants at present time."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

What site did they apply to?

Laureate Institute for Brain Research

Why did patients apply to this trial?

I've tried many treatments and only a benzo is effective. I've tried several different types of prescription medications and now at point where I need help can not work do to how bad my condition is I been diagnosed with depression and generalized anxiety and anxiety attacks I'm 25 minutes from facility I'm open to any help or guidance if I don't qualify sincerely.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression

2023. "Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06004115.

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