Health TrialsbyHealthPanel

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

ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorMclean Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The subjects for this research will be 228 participants recruited from the community by the Center for Depression, Anxiety and Stress Research (Director: Dr. Diego Pizzagalli, Ph.D.). Demographically-matched participants will include: (1) 38 participants with current MDD; (2) 38 participants with past MDD; and (3) 38 healthy controls.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Aversive stimuli

    Device

    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).

  • PET radiotracer

    Drug

    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.

Treatment groups

228 Participants
are divided into 3 treatment groups
Group A: MDD subjects2 interventions
Group B: Remitted MDD subjects2 interventions
Group C: Control subjects2 interventions

Trial outcomes

Primary outcomes

1

Clinical Interview

For assessing psychological state

Time frame
Baseline
2

Behavioral Performance on the Probabilistic Reward Task (PRT)

the PRT assesses individuals' ability to learn from rewards

Time frame
Baseline
3

MRI Data

For testing the neural correlates of approach-avoidance decision making behaviors

Time frame
within 30 days of Screening Visit
4

Salivary Cortisol

For assessing stress level

Time frame
Baseline

Secondary outcomes

1

Beck Depression Inventory-II (BDI)

self-report measure of depressive symptoms

Time frame
Change from Baseline at 6 months and 12 months after the PET visit
2

Childhood Trauma Questionnaire (CTQ)

self-report measure of childhood trauma

Time frame
Baseline
3

Medical Outcome Survey-Short form (SF-36)

self-report with subscales measuring physical functioning, physical role functioning, social functioning, etc.

Time frame
Change from Baseline at 6 months and 12 months after the PET visit
4

Perceived Stress Scale (PSS)

self-report measure of stress levels

Time frame
Change from Baseline at 6 months and 12 months after the PET visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mclean Hospital

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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