Clinical trial NCT04671836: Lorazepam Effects on Neuroimaging Measures
Official title: Lorazepam Effects on Neuroimaging Measures: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Lorazepam
Neuroimaging
Keywords: lorazepam
functional connectivity
spectroscopy
healthy volunteers
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This within-subject, double blind, randomized controlled study will investigate the effects of a widely used benzodiazepine (BZD), lorazepam, on various neuroimaging measures. The investigators will be assessing the relationship of lorazepam to resting state functional connectivity and other neuroimaging measures. Specifically, the investigators will be using a pre-identified metric, the striatal connectivity index (SCI), (Sarpal et al. 2015, 2016), a prognostic biomarker of treatment response assessing the connectivity between regions of the striatum and the cortex. The investigators hypothesize that lorazepam administration will be associated with greater SCI values compared with placebo administration; consistent with previous work suggesting short-acting benzodiazepines increase functional connectivity across brain networks.


Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18-40
4. In general good health as evidenced by medical history
5. Ability to take oral medication and be willing to adhere to the study medication regimen
6. For women of reproductive potential, negative pregnancy test and agreement to use a medically accepted birth control method.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Pregnancy or lactation
2. Contraindications to MR imaging (i.e. pacemaker)
3. Known allergic reactions to components of the lorazepam
4. Current smoker or tobacco use
5. Concurrent use of any psychotropic medications, anticonvulsants, opioids or any other medication with effects on the CNS.
6. Acute narrow-angle glaucoma
7. Current or past history of a substance use disorder and/or a positive urine toxicology test.

Primary outcomes:
measure: To understand the impact of lorazepam on functional connectivity measures collected using resting state functional magnetic imaging (rs-fMRI).
timeFrame: 2 weeks
Secondary outcomes:
measure: The goal is to study the impact of lorazepam on glutamate, glutamine and GABA in the striatum.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital
state: New York
Study officials:
affiliation: Northwell Health
name: Juan A Gallego, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sarpal DK, Argyelan M, Robinson DG, Szeszko PR, Karlsgodt KH, John M, Weissman N, Gallego JA, Kane JM, Lencz T, Malhotra AK. Baseline Striatal Functional Connectivity as a Predictor of Response to Antipsychotic Drug Treatment. Am J Psychiatry. 2016 Jan;173(1):69-77. doi: 10.1176/appi.ajp.2015.14121571. Epub 2015 Aug 28.
citation: Sarpal DK, Robinson DG, Lencz T, Argyelan M, Ikuta T, Karlsgodt K, Gallego JA, Kane JM, Szeszko PR, Malhotra AK. Antipsychotic treatment and functional connectivity of the striatum in first-episode schizophrenia. JAMA Psychiatry. 2015 Jan;72(1):5-13. doi: 10.1001/jamapsychiatry.2014.1734.