Beyond Monoamines: The Role of the Nociceptin/Orphanin FQ Receptor in Major Depression
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 45 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Information collected through MRI, PET, biospecimens (i.e., blood, saliva) and behavioral tasks will be used to predict depressive symptoms in the future."
- "This will be achieved through an innovative method of using functional magnetic resonance imaging (fMRI) during an approach/avoidance decision-making task, in addition to a resting positron emission tomography (PET) scan."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at a brain system called the nociceptin/orphanin FQ receptor system in adults ages 18 to 45 with current or past major depression. It also studies how people with past depression make decisions. Researchers will use brain scans, blood and saliva samples, and tasks to help predict future depression symptoms.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 to 45; all genders, races, and ethnic backgrounds may join.
- Able to give written consent and fluent in English.
- Right-handed.
- Have not taken medicines that affect mood, thoughts, or behavior for at least 2 weeks.
- Have an iPhone or Android smartphone for study check-ins.
- For the past depression group: have a history of major depression that meets standard diagnosis rules.
- For the current depression group: have major depression now that meets standard diagnosis rules.
- For either depression group: no anxiety disorder in the past 2 months.
Who can't join
- Suicidal thoughts that make care outside a hospital unsafe, as judged by the study clinician. The study will refer these people for treatment right away.
- Pregnant, or able to become pregnant but not using a birth control method accepted by the study.
- Serious or unstable medical illness; past seizures; an underactive thyroid; or abnormal heart tracing (ECG) or lab results.
- For the depression groups: past mental illness other than depression or anxiety. Also excluded are depression with psychosis, such as seeing things that are not there, and past or current dementia or a screening memory-test score below 26.
- Past drug or alcohol use disorder. People with depression may qualify if the disorder was mild and ended at least 12 months ago.
- Past use of cocaine, stimulants, or drugs that act on the brain chemical dopamine; or current use of other medicines that affect mood, thoughts, or behavior.
- Ever had electroconvulsive therapy (ECT), a treatment that uses electrical pulses to the brain, or cannot meet MRI scan safety rules.
- Cannot safely have a tube placed in an artery for blood sampling. Reasons include poor blood flow to the hand, Raynaud's syndrome, past anemia or bleeding problems, or fainting during blood draws.
Simplified for readability. The official criteria below are what the study team uses.
Official 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).
Study sites (1)
MA
- McLean Hospital · Belmont, MA 02478Tracy Lam, BS · Study contact · 617-855-4437 · clam@mclean.harvard.eduMore trials in Belmont