Investigating brain responses to threats in anxiety and depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study examines how the brain processes threats in individuals with anxiety and depression by using an anti-anxiety medication, Lorazepam, and advanced brain imaging techniques. Participants will be divided into three groups based on their mental health diagnoses: those with both major depressive disorder and anxiety, those with only major depressive disorder, and those with only anxiety disorders. Each participant will undergo two experimental sessions involving a startle response task and functional MRI scans to assess their brain activity in response to threats. The goal is to understand the differences in threat sensitivity and brain circuitry among these groups, potentially leading to targeted treatments.

Why it matters

Who can join: the full rules

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

Where it's running

• Laureate Institute for Brain Research
  Tulsa, Oklahoma, United States Recruiting

Study contacts

• Principal investigator: Maria Ironside, DPhil — Laureate Institute for Brain Research
• Study coordinator: Maria Ironside, DPhil
• Email: mironside@laureateinstitute.org
• Phone: 16174175065

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.