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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 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.

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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?

Interventions

  • OTHER Placebo
  • DRUG Lorazepam

Study Locations (1)

Oklahoma

  • Laureate Institute for Brain Research - Tulsa

Trial Details

FieldValue
Enrollment Target 165 participants
Start Date 2023-11-08
Est. Completion 2027-12-31
Phase Phase 4

What the Registry Record Tells You About NCT06004115

The ClinicalTrials.gov registry entry for NCT06004115 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 165 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (79% lower). The listed sponsor is Laureate Institute for Brain Research, which has 45 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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