NCT05630963 Beyond Monoamines: The Role of the Nociceptin/Orphanin FQ Receptor in Major Depression
| NCT ID | NCT05630963 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mclean Hospital |
| Condition | Major Depressive Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 228 participants |
| Start Date | 2021-12-29 |
| Primary Completion | 2026-10-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 228 participants in total. It began in 2021-12-29 with a primary completion date of 2026-10-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria for all participants: * All genders, races, and ethnic origins, aged between 18 and 45 * Capable of providing written informed consent, and fluent in English * Right-handed * Absence of any psychotropic medications for at least 2 weeks * Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment) Inclusion Criteria for "Remitted MDD" group: * Meets inclusion criteria for all subjects, plus: * History of MDD as defined by DSM-5 * Absence of anxiety disorder for the past two months Inclusion Criteria for "Current MDD" group: * Meets inclusion criteria for all subjects, plus: * Presence of MDD as defined by DSM-5 * Absence of anxiety disorder for the past two months Exclusion Criteria for all participants: * Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment * Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, or partner with vasectomy) * Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease * History of seizure disorder * History of psychiatric illnesses, other than depression or anxiety disorders among the Current MDD and Remitted MDD groups * History of substance use disorder or alcohol use disorder (as these terms are defined by DSM-5); except depressed subjects may have a history of 'Mild' substance/alcohol use disorder only if it ended as least 12 months ago * History of cocaine or stimulant use or dopaminergic drugs * History or current diagnosis of dementia, or a score of \< 26 on the Mini Mental State Examination at the screening visit; * Patients with mood congruent or mood incongruent psychotic features * Current use of other psychotropic drugs * Clinical or laboratory evidence of hypothyroidism * Patients with a lifetime history of electroconvulsive therapy (ECT) * Failure to meet standard MRI safety requirements * Abnormal ECG and lab results * History of seizure disorder * Contraindications for arterial line (e.g., abnormal result on Allen test, Raynaud's syndrome, history of anemia or bleeding disorder, history of fainting from blood draws).
Contact & Investigator
Diego Pizzagalli, PhD
PRINCIPAL INVESTIGATOR
Mclean Hospital
Frequently Asked Questions
Who can join the NCT05630963 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05630963 currently recruiting?
Yes, NCT05630963 is actively recruiting participants. Contact the research team at mclrew41study@mgb.org for enrollment information.
Where is the NCT05630963 trial being conducted?
This trial is being conducted at Belmont, United States.
Who is sponsoring the NCT05630963 clinical trial?
NCT05630963 is sponsored by Mclean Hospital. The principal investigator is Diego Pizzagalli, PhD at Mclean Hospital. The trial plans to enroll 228 participants.