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

Launched by LAUREATE INSTITUTE FOR BRAIN RESEARCH, INC. · Aug 16, 2023

Keywords

ClinConnect Summary

This clinical trial is designed to study how people with both depression and anxiety respond to threats compared to those with only depression or only anxiety. Researchers are using a medication called Lorazepam, which helps reduce anxiety, and advanced brain imaging techniques to see how different brain areas react to threats. The goal is to understand if and how these responses differ among the groups, which could help in developing better treatments for individuals facing both conditions.

To participate, individuals must be between 18 and 65 years old and have a diagnosis of major depressive disorder (MDD) and/or an anxiety disorder. Participants will take either Lorazepam or a placebo (a sugar pill) and complete a series of tests, including a brain scan that lasts about 1.5 hours. Overall, the study will involve around 10.5 hours of participation. It's important to note that certain medical conditions and medications may exclude some people from joining the trial. If you're interested in learning more about participating, please consult with your healthcare provider.

Gender

ALL

Eligibility criteria

• 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