RecruitingNCT05630963

Beyond Monoamines: The Role of the Nociceptin/Orphanin FQ Receptor in Major Depression


Sponsor

Mclean Hospital

Enrollment

228 participants

Start Date

Dec 29, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

This study looks at the role of the Nociceptin/Orphanin FQ receptor system in the brain of individuals with current or past major depressive disorder (MDD). It also examines how individuals with a history of depression make certain decisions and which brain regions are involved in such decisions. Information collected through MRI, PET, biospecimens (i.e., blood, saliva) and behavioral tasks will be used to predict depressive symptoms in the future.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring how a brain chemical system (beyond the usual serotonin and dopamine targets) may play a role in major depression. Researchers want to understand why some people become depressed and how different brain systems respond. **You may be eligible if...** - You are between 18 and 45 years old (any gender, race, or ethnicity) - You are right-handed - You are fluent in English and can give written consent - You have not taken any psychiatric medications for at least 2 weeks - You own a smartphone (iPhone or Android) **You may NOT be eligible if...** - You are currently taking psychiatric medications - You are not fluent in English - You are left-handed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAversive stimuli

Electrotactile stimulation will be used as the aversive stimulus. The aversive stimulus is delivered in the form of a mild half-second stimulation to the ankle, calibrated to a subjective threshold that is uncomfortable but not painful. This stimulation is delivered by Digitimer DS8R Constant Current Stimulator (Digitimer North America, LLC. Ft. Lauderdale, FL). Its previous model DS71 has been safely implemented in studies with previously MGH-approved IRB's (Milad et al., 2013).

DRUGPET radiotracer

A Nociceptin/Orphanin FQ ("N/OFQ") peptide tracer (\[11C\] NOP-1A) will be used as the PET radiotracer. Approximately 10 mCi of this tracer will be delivered intravenously as a slow bolus over 60 seconds with beginning of the PET imaging acquisition. Approximately 60 ml of blood will be drawn from an artery throughout the dynamic PET acquisition in order to measure the blood N/OFQ levels.


Locations(1)

McLean Hospital

Belmont, Massachusetts, United States

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NCT05630963


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