Brain scans reveal how anxiety and depression team up on threat
NCT ID NCT06004115
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study uses brain imaging and a single dose of the anti-anxiety drug lorazepam to understand how people with both depression and anxiety disorders process threats differently than those with depression alone. About 165 adults will complete two sessions involving startle tests and MRI scans. The goal is to uncover brain circuit differences that could guide better treatments for co-occurring anxiety and depression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lorazepam (a single 1 mg dose)
- What this could lead to
- If successful, this could help doctors better understand and treat co-occurring anxiety and depression by revealing how the brain responds to threat.
- What could go wrong
- This is an early mechanistic study, not a treatment trial. It uses a single dose of an existing drug to probe brain function, so it won't directly lead to new therapies. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 165 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
An individual must meet the following criteria to be considered eligible to participate in the study: Inclusion Criteria: All subjects: * 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 MDD and AD-MDD subjects: * Current major depressive episode assessed by clinician with guidance from the MINI; * Minimum score of 55 on PROMIS Depression scale AD and AD-MDD subjects: * 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 Criteria: All subjects: * 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. MDD subjects: * Current (assessed by clinician with guidance from the MINI) anxiety disorder; * Score of \> 60 on PROMIS Anxiety Scale AD subjects: * Current or past recurrent major depressive episodes assessed by clinician with guidance from the MINI; * Score of \> 60 on PROMIS Depression scale
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Laureate Institute for Brain Research
RECRUITINGTulsa, Oklahoma, 74136, United States
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