Acute Effect of Lorazepam on Brain Activity Measured by Magnetoencephalograpy (MEG) and Electroencephalography (EEG)

Orasi Medical

Status: Unknown

Conditions: Healthy Subjects

Treatments: Drug: Placebo; Drug: Lorazepam

Study type: Interventional

Funder types: Industry

Identifiers

NCT01272778

ADE-LDR 10-02

Details and patient eligibility

About

This placebo-controlled crossover study is intended to measure the effect of four doses of lorazepam on brain activity measured by magnetoencephalography (MEG) and electroencephalography (EEG). This study will conduct MEG and EEG scans as well as simple cognition testing on 16 healthy male volunteers. On each of five study days subjects will be randomized to receive either 0.2, 0.5, 1.0 or 2.0 mg lorazepam or placebo. Brain activity will be measured by MEG and EEG in each subject a total of 4 times each study day: prior to medication administration and 2, 4, and 6 hours after medication administration. Blood samples to determine medication levels and cognition testing will be performed at pre-medication baseline and immediately after each post-medication scan time. Data will be analyzed to identify changes in brain activity compared to baseline and placebo administration using both standard approaches and the Orasi Synchronous Neural Interaction® (SNI) test. This study will test the hypothesis that dose-response changes in brain functional activity can be accurately measured by MEG/EEG in healthy volunteer subjects after single, acute doses of lorazepam.

Enrollment: 16 estimated patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is male between 18 and 35 years of age at the time of screening.
• Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
• Subject is a non-smoker.
• Subject is judged to be in good health based on medical history and brief physical examination and electrocardiogram.
• Subject has normal or corrected to normal visual and auditory acuity.
• Subject agrees to refrain from caffeine 24 hours prior to and then throughout each Study Day.
• Subject agrees to refrain from using alcohol for 48 hours prior to and then throughout each Study Day.

Exclusion criteria

• Subject has a diagnosis of a significant neurological condition including Alzheimer's disease, Parkinson's disease, vascular dementia, Lewy body dementia or frontal temporal dementia, human immunodeficiency virus, multiple sclerosis, or severe traumatic brain injury.
• Subject has a history of primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, delusional disorder) or bipolar disorder.
• Subject has a history of seizures, epilepsy, stroke, peripheral neuropathy, head trauma with persistent post-concussive symptoms, ADHD, dyslexia or other clinically significant neurological disease or cognitive impairment.
• Subject has a lifetime or current history of alcohol or substance abuse/dependence.
• Subject has a history of multiple or severe allergies, or has had an anaphylactic reaction or intolerability to prescription or non-prescription drugs. This includes a documented or subject-verified allergy.
• Subject had an MRI 2 weeks prior to Study Day 2.
• Subject has metal braces or pacemaker that may interfere with the MEG scan.
• Subject is unable to complete the MEG scan procedure.
• The investigator has any concern regarding the safe participation of a subject in the study, or if for any other reason the investigator considers the subject inappropriate for study participation

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

16 participants in 5 patient groups, including a placebo group

Lorazepam 0.2 mg

Experimental group

Description:

All subjects receive lorazepam 0.2 mg in this crossover design.

Treatment:

Drug: Lorazepam

Drug: Lorazepam

Drug: Lorazepam

Drug: Lorazepam

Lorazepam, 0.5 mg

Experimental group

Description:

All subjects receive lorazepam 0.5 mg in this crossover design.

Treatment:

Drug: Lorazepam

Drug: Lorazepam

Drug: Lorazepam

Drug: Lorazepam

Lorazepam, 1.0 mg

Experimental group

Description:

All subjects receive lorazepam 1.0 mg in this crossover design.

Treatment:

Drug: Lorazepam

Drug: Lorazepam

Drug: Lorazepam

Drug: Lorazepam

Lorazepam, 2.0 mg

Experimental group

Description:

All subjects receive lorazepam 2.0 mg in this crossover design

Treatment:

Drug: Lorazepam

Drug: Lorazepam

Drug: Lorazepam

Drug: Lorazepam

Sugar pill

Placebo Comparator group

Description:

All subjects receive a sugar pill in this crossover design.

Treatment:

Drug: Placebo