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Understanding Threat Sensitivity in Anxiety and Depression

This study is looking at how the brain processes threats in people with depression, anxiety, or both. Researchers will use the anti-anxiety drug Lorazepam or a placebo (an inactive pill) to see how it affects your brain's response to threat. They will use brain imaging to understand these processes. The study aims to enroll up to 165 adults between 18 and 65 years old who have depression, anxiety, or both. The main goal is to measure how much your eye blinks in response to a startling sound when you feel threatened, comparing those with both anxiety and depression to those with only depression. The study's current recruitment status is unclear.

Study design
This is a double-blind, placebo-controlled crossover study, meaning neither you nor the researchers will know if you're receiving Lorazepam or placebo. Up to 165 participants will be enrolled across three groups.
What's involved
You would participate in a two-session study. The primary endpoint is measured 1-2 hours after receiving either Lorazepam or placebo, within 1-5 weeks after you enroll.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06004115

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

Recruiting
PHASE4Ages 18–65InterventionalBasic science
Laureate Institute for Brain Research, Inc.
~165 participants
Updated 2025-10-31 on ClinicalTrials.gov
What's tested:LorazepamPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Eyeblink startle magnitude under threat in AD-MDD compared to MDD.
Measured over 1-2 hours after single session placebo administration, an average of 1-5 weeks after enrollment (placebo could be session 1 or session 2)

Conditions

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

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NCT06004115

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Laureate Institute for Brain Research

    Tulsa, Oklahomastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Maria Ironside, DPhil · PRINCIPAL_INVESTIGATOR · Laureate Institute for Brain Research

Who to contact

Maria Ironside, DPhil
[email protected]
16174175065
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Female or male sex assigned at birth;
Age 18-65;
Normal or corrected to normal vision/hearing, as protocol elements may not be valid otherwise;
Fluent English speaker, capable of providing written informed consent
Current major depressive episode assessed by clinician with guidance from the MINI;
Minimum score of 55 on PROMIS Depression scale
Current anxiety disorder (generalized anxiety disorder, panic disorder, agoraphobia and social phobia) assessed by clinician with guidance from the MINI;
Minimum score of 55 on PROMIS Anxiety Scale

Exclusion

Has uncontrolled, clinically significant neurologic (including seizure disorders): cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality, which may impact the ability of the subject to participate or potentially confound the study results;
Reported body mass index (BMI) \> 40;
History of moderate or severe traumatic brain injury, as assessed by a TBI questionnaire;
History of eating disorder or obsessive-compulsive disorder, schizophrenia, schizo-affective disorder, bipolar disorder or any sign of psychosis;
Current post-traumatic stress disorder (PTSD) diagnosis (although history of trauma is allowed);
Current use of medications with major effects on brain function or the fMRI hemodynamic response (e.g., methylphenidate, acetazolamide, excessive caffeine intake \> 1000 mg/day) following an initial list compiled by LIBR but also assessed on a case-by-case basis. Individuals who are currently on medication (antidepressants such as SSRIs, TCAs, SNRIs, and Bupropion) and who have not undergone dose or medication changes over the past 6 weeks will be allowed to participate;
Current benzodiazepine or opiate use;
Moderate to severe current substance use disorder, defined as 5 or more symptoms of the criteria for Substance Use Disorder according to DSM 5;
Drug or alcohol intoxication (based on positive UTOX or breathalyzer test at screening or study session) or reported alcohol/drug withdrawal, last cannabis use must be \>48 hours prior to study session;
Has a risk of suicide according to the Investigator's clinical judgement or per Columbia-Suicide Severity Rating Scale (C-SSRS) or equivalent PhenX instrument, the subject scores "yes" on items 4 or 5 in the Suicidal Ideation section with referent to a 30-day period prior to Screening/Baseline or the subject has had one or more suicidal attempts with reference to a 2-year period prior to Screening;
MRI contraindications;
Is pregnant or lactating or intending to become pregnant before, during, or within 12 weeks after participating in this study; or intending to donate ova during this time-period;
Any subject judged by the Investigator to be inappropriate for the study.
Current (assessed by clinician with guidance from the MINI) anxiety disorder;
Score of \> 60 on PROMIS Anxiety Scale
Current or past recurrent major depressive episodes assessed by clinician with guidance from the MINI;
Score of \> 60 on PROMIS Depression scale

What this trial measures

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

    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.