RECOVERS - Realigning Emotion and COgnition Via PrEcision Regulation NetworkS

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Jul 26, 2023

Keywords

ClinConnect Summary

The RECOVERS trial is studying how changes in brain activity relate to emotions, attention, and memory in people with and without depression. Researchers will use advanced imaging techniques, like MRI and a method called functional near-infrared spectroscopy (fNIRS), to see how the brain responds during specific tasks. They are also using a safe technique called non-invasive brain stimulation to explore different parts of the brain. The goal is to develop better treatments for emotional issues, especially major depressive disorder.

To participate, you need to be between 18 and 65 years old and speak English. In the first study, healthy volunteers are needed, while the second study focuses on individuals experiencing depression. Participants will undergo assessments and follow a study schedule, and women of childbearing age will need to have a negative pregnancy test. Overall, this trial aims to better understand how the brain works in relation to emotions, which could lead to new ways to help those struggling with depression.

Gender

ALL

Eligibility criteria

• • Study 1
• • Inclusion Criteria
• • Male or female
• • Age 18-65
• • Endorse good health with no history of mental or physical illness or implanted metal
• • English as a primary language
• • Capacity to consent
• • Negative urine pregnancy test if female of childbearing potential
• • Willingness to adhere to the study schedule and assessments
• • Exclusion Criteria
• • Any current psychiatric diagnosis or current Clinical Global Impression ratings of psychiatric illness \> 1
• • Neurodevelopmental disorders, history of CNS disease, concussion, overnight hospitalization, or other neurologic sequela, tumors, seizures, meningitis, encephalitis, or abnormal CT or MRI of the brain
• • Any head trauma resulting in loss of consciousness
• • Visual impairment (except the use of glasses)
• • Inability to complete cognitive testing
• • Active participation or plan for enrollment in clinical trial affecting the psychosocial function
• • Repeated abuse or dependence upon drugs (excluding nicotine and caffeine) or taking medications including stimulants, modafinil, thyroid medication, or steroids
• • Implanted devices/ferrous metal of any kind
• • History of seizure or epilepsy, currently taking medications that lower seizure thresholds
• • Claustrophobia or other conditions that would prevent the MRI assessment.
• • Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term).
• • o Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a man capable of fathering a child before, during, and/or after participation precautions should be taken. Examples of acceptable methods of birth control for participants involved in the study include birth control pills, patches, IUDs, condoms, sponges, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant.
• • Inability to adhere to the treatment schedule
• • Study 2
• • Inclusion Criteria
• • Male or female
• • Age 18-65
• • Endorse current depression, identified via the Hamilton Depression Rating Scale (HAM-D scores ≥ 17), but no history of psychosis or mania, determined via the Quick Structured Clinical Interview for DSM-5 Disorders (SCID).
• • English as a primary language
• • Capacity to consent
• • Negative urine pregnancy test if female of childbearing potential
• • Willingness to adhere to the study schedule and assessments
• • Exclusion Criteria
• • Neurodevelopmental disorders, history of CNS disease, concussion, overnight hospitalization, or other neurologic sequela, tumors, seizures, meningitis, encephalitis, or abnormal CT or MRI of the brain
• • Any head trauma resulting in loss of consciousness
• • Visual impairment (except the use of glasses)
• • Inability to complete cognitive testing
• • Active participation or plan for enrollment in clinical trial affecting the psychosocial function
• • Repeated abuse or dependence upon drugs (excluding nicotine and caffeine) or taking medications including stimulants, modafinil, thyroid medication, or steroids
• • Implanted devices/ferrous metal of any kind
• • History of seizure or epilepsy, currently taking medications that lower seizure thresholds