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

Conditions

• Anxiety Disorders
• Anxiety and Fear
• Anxious Depression
• Depression
• Depression, Anxiety
• Fear

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Lorazepam — DRUG
  1mg of Lorazepam will be prepared by pharmacy (Barnes, Tulsa) in capsule form
• Placebo — OTHER
  placebo will be prepared by pharmacy (Barnes, Tulsa) in capsule form

Study Details

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 1.5 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?

Key Dates

Start date

Nov 8, 2023

Status verified

Oct 2025

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

165 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Lorazepam
  Participants will receive a single 1mg dose of Lorazepam, to be taken orally under registered nurse (RN) supervision
• Placebo Comparator: Placebo
  Participants will receive a single dose of placebo, to be taken orally under RN supervision

Primary Outcome Measure

Eyeblink startle magnitude under threat in AD-MDD compared to MDD. [ Time Frame: 1-2 hours after single session placebo administration, an average of 1-5 weeks after enrollment (placebo could be session 1 or session 2) ]

Central Contacts

• Maria Ironside, DPhil
  16174175065
  [email protected]

Locations (1)

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