Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression
Status:
Recruiting
Trial end date:
2027-04-30
Target enrollment:
Participant gender:
Summary
This mechanistic study uses an anti anxiety drug and brain imaging to study the threat
processing system and associated brain circuits in people with depression, anxiety disorders
and comorbid depression and anxiety disorders. In a double blind, placebo controlled
crossover design, up to 65 individuals will be recruited who will have a diagnosis of major
depressive disorder (MDD) and at least one anxiety disorder (AD) (AD-MDD group), up to 65
participants will have a diagnosis of MDD and no diagnosis of an AD and up to 65 participants
will have no diagnosis of MDD and a diagnosis of at least one AD will be enrolled to
participate in an two session study to obtain 150 completers (50 per group). All participants
will receive a single dose of Lorazepam and placebo (order randomized) taken orally. After
the ~2.5 hr screening session, participants will complete two identical ~5 hr experimental
sessions, each of which include a 30 min eyeblink startle session and a 1 hr functional
magnetic resonance imaging (MRI) brain scan session. The total time involved in the study is
approximately 10.5 hours.
The main questions the study seeks to answer are:
- are people with comorbid depression and anxiety different than those with depression
alone in terms of their eyeblink startle response to threat?
- are people with comorbid depression and anxiety different than those with depression
alone in terms of their brain activation in response to threat?
- are people with comorbid depression and anxiety different than those with depression
alone in terms of their responses to anxiety drugs?
Phase:
Phase 4
Details
Lead Sponsor:
Laureate Institute for Brain Research, Inc.
Collaborators:
California Institute of Technology National Institute of Mental Health (NIMH)