Healthy SubjectsNCT01272778
Acute Effect of Lorazepam on Brain Activity Measured by Magnetoencephalograpy (MEG) and Electroencephalography (EEG)
A study testing Lorazepam in people with Healthy Subjects, run by Orasi Medical, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Lorazepam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Alexian Brothers Neurosciences Institute
Elk Grove Village, Illinois, 60007
Christina Kay, MA, 847-981-3570, christina.kay@abbhh.net
Donnell Carmichael, PsyD, 847-981-5771, donnell.carmichael@abbhh.net
About this study
Official title: Acute Effect of Four Doses of Lorazepam on Brain Activity Measured by MEG, EEG and the Synchronous Neural Interaction™ Test
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.
- Conditions
- Healthy Subjects
- Being tested
- Lorazepam, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorazepamDrug
Oral capsule, 0.2 mg, single acute dose
LorazepamDrug
oral capsule, 0.5 mg, single acute dose
LorazepamDrug
oral capsule, 1.0 mg, single acute dose
LorazepamDrug
oral capsule, 2.0 mg, single acute dose
PlaceboDrug
oral capsule, single acute dose
| Study group | Role | What they receive |
|---|---|---|
| Lorazepam 0.2 mg | Experimental | All subjects receive lorazepam 0.2 mg in this crossover design. Receives: Drug: Lorazepam |
| Lorazepam, 0.5 mg | Experimental | All subjects receive lorazepam 0.5 mg in this crossover design. Receives: Drug: Lorazepam |
| Lorazepam, 1.0 mg | Experimental | All subjects receive lorazepam 1.0 mg in this crossover design. Receives: Drug: Lorazepam |
| Lorazepam, 2.0 mg | Experimental | All subjects receive lorazepam 2.0 mg in this crossover design Receives: Drug: Lorazepam |
| Sugar pill | Placebo comparator | All subjects receive a sugar pill in this crossover design. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlated Brain Activity using MEG and SNI analysis
The identification and characterization of a pattern of synchronous brain activity that is specifically altered by administration of ascending doses of lorazepam compared to pre-medication baseline and placebo
Measured: 2 hours after dosing with lorazepam
Secondary outcomes (1)
Correlated Brain Activity using MEG and standard analyses
Standard frequency-domain analysis of the MEG data to identify and quantify medication-induced changes in signal power in particular frequency bands associated with brain functional activity
Measured: 2 hours after dosing with lorazepam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startOct 2010
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orasi Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Concetta Forchetti, MD, PhD, Principal investigator, Alexian Brothers Neurosciences Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272778
- Sponsor's protocol ID
- ADE-LDR 10-02
- Status last verified
- Jan 2011
- First submitted
- 5 Jan 2011
- Last updated
- 10 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Four Doses of Lorazepam on Brain Activity Measured by MEG, EEG and the Synchronous Neural Interaction™ Test
- ClinicalTrials.gov ID
- NCT01272778
- Acronym / sponsor ID
- ADE-LDR 10-02
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Orasi Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 10 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Lorazepam 0.2 mg | Experimental | Drug: LorazepamAll subjects receive lorazepam 0.2 mg in this crossover design. |
| Lorazepam, 0.5 mg | Experimental | Drug: LorazepamAll subjects receive lorazepam 0.5 mg in this crossover design. |
| Lorazepam, 1.0 mg | Experimental | Drug: LorazepamAll subjects receive lorazepam 1.0 mg in this crossover design. |
| Lorazepam, 2.0 mg | Experimental | Drug: LorazepamAll subjects receive lorazepam 2.0 mg in this crossover design |
| Sugar pill | Placebo comparator | Drug: PlaceboAll subjects receive a sugar pill in this crossover design. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LorazepamOral capsule, 0.2 mg, single acute dose | Drug | Lorazepam 0.2 mg |
| Lorazepamoral capsule, 0.5 mg, single acute dose | Drug | Lorazepam, 0.5 mg |
| Lorazepamoral capsule, 1.0 mg, single acute dose | Drug | Lorazepam, 1.0 mg |
| Lorazepamoral capsule, 2.0 mg, single acute dose | Drug | Lorazepam, 2.0 mg |
| Placebooral capsule, single acute dose | Drug | Sugar pill |
Primary outcome
Correlated Brain Activity using MEG and SNI analysis
Time frame: 2 hours after dosing with lorazepam
The identification and characterization of a pattern of synchronous brain activity that is specifically altered by administration of ascending doses of lorazepam compared to pre-medication baseline and placebo
1 secondary outcome
Correlated Brain Activity using MEG and standard analyses
Time frame: 2 hours after dosing with lorazepam
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2011.
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Concetta Forchetti, MD, PhD principal investigator
Alexian Brothers Neurosciences Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lorazepam in people with Healthy Subjects, run by Orasi Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina Kay, MA (847-981-3570, christina.kay@abbhh.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlated Brain Activity using MEG and SNI analysis (time frame: 2 hours after dosing with lorazepam). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2011.