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NCT06004115 · ClinicalTrials.gov registry record · Phase 4
Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression
A Phase 4 study of Depression and Anxiety Disorders, sponsored by Laureate Institute for Brain Research.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 165
- Enrollment target
- 1
- Study location
NCT06004115: Recruiting Phase 4 study of Depression and Anxiety Disorders, sponsored by Laureate Institute for Brain Research.
NCT06004115 is a Phase 4 study of Depression and Anxiety Disorders that is actively recruiting participants, run by Laureate Institute for Brain Research. The registered enrollment target is 165 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06004115, a Phase 4 study of Depression and Anxiety Disorders, is actively recruiting participants, sponsored by Laureate Institute for Brain Research.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 165 participants
- Enrollment target
- 1
- Study location
Study 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 1.5 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?
Primary Outcome
Difference in magnitude of eyeblink startle response under threat of predictable and unpredictable shock conditions compared to neutral condition in the Neutral, Predictable, Unpredictable (NPU) Threat Task measured with electromyography. Comparing the AD-MDD group to the MDD group.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Lorazepam
Study Locations (1)
Oklahoma
- Laureate Institute for Brain Research - Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2023-11-08 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 4 |
What NCT06004115 shows while recruiting
NCT06004115 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (79% lower).
The record links to 6 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06004115 reports a single indexed study location in Oklahoma.
Frequently Asked Questions
What is clinical trial NCT06004115 about?
NCT06004115 is a clinical study titled "Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression". 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 individu...
What is the current status of trial NCT06004115?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 165 participants. The study started on 2023-11-08. Estimated completion is 2027-12-31.
What conditions does trial NCT06004115 study?
This clinical trial studies the following conditions: Depression, Anxiety Disorders, Depression, Anxiety, Fear, Anxiety and Fear.
What interventions are being tested in trial NCT06004115?
The interventions under investigation include: Placebo (OTHER), Lorazepam (DRUG).
Who is sponsoring clinical trial NCT06004115?
This trial is sponsored by Laureate Institute for Brain Research, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06004115 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06004115's enrollment target sits among peer trials
165 233rd of 679 higher than 447 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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