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Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Pharmacological Manipulation

ConditionsDepressive Disorder, MajorAnxiety Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-45
SponsorMclean Hospital

About this trial

The study will investigate whether a nociceptin receptor antagonist will normalize neural and behavioral processes of approach/avoidance decision-making in unmedicated individuals with major depressive disorder (MDD) and anxiety disorders. More specifically, the study aims to investigate dysregulation within (1) corticostriatal-midbrain circuitry and (2) nociceptin/orphanin FQ peptide and the nociceptin receptor (NOPR).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

DSM-5 diagnostic criteria for MDD, Generalized Anxiety Disorder, Social Phobia, Panic Disorder, Post Traumatic Stress (diagnosed using the SCID-5)

Written informed consent

For MDD subjects, a baseline Hamilton Depression Rating Scale score > 16 (17-item version)

Right-handed

Disqualifiers

Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician

Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception

Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease

History of seizure disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nociceptin Receptor Antagonist

    Drug

    Participants in the experimental arms will receive 40 mg of the nociceptin receptor antagonist. Peak concentrations are achieved 2-4 hours post-administration.

  • Aversive stimuli

    Device

    As part of the approach/avoidance task, electrotactile stimulation will be used. 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 within Massachusetts General Hospital (Milad et al., 2013).

Treatment groups

112 Participants
are divided into 4 treatment groups
Group A: Participants with MDD or an anxiety disorder receiving the nociceptin receptor antagonistExperimental treatment 2 interventions
Group B: Participants with MDD or an anxiety disorder receiving the placeboPlacebo comparator 1 intervention
Group C: Healthy controls receiving the nociceptin receptor antagonistExperimental treatment 2 interventions
Group D: Healthy controls receiving the placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (SCID-5)

Diagnostic assessment

Time frame
Baseline
2

Magnetic Resonance Imagining

Both structural and functional brain images

Time frame
Within 30 days of the clinical interview
3

Approach/Avoidance Task

A novel behavioral task assessing approach/avoidance decision-making

Time frame
During the MRI scan
4

Orphanin FQ/Nociceptin assays (using blood samples)

Measure of Orphanin FQ/Nociceptin

Time frame
On the day of the MRI scan

Secondary outcomes

1

Beck Depression Inventory-II

21-item measure of depression severity; scores range from 0 to 63; higher scores indicate higher depression severity

Time frame
Baseline, 6-month follow-up, 12-month follow-up
2

Hamilton Rating Scale for Depression

17-item measure of depression severity; scores range from 0 to 34; higher scores indicate higher depression severity

Time frame
Baseline, 6-month follow-up, 12-month follow-up
3

Perceived Stress Scale

14-item measure of stress appraisal; scores range from 0 to 56; higher scores indicate higher perceived stress

Time frame
Baseline, 6-month follow-up, 12-month follow-up
4

Snaith Hamilton Pleasure Scale

14-item measure of anhedonia; scores range from 14 to 56; higher scores indicate higher anhedonia

Time frame
Baseline, 6-month follow-up, 12-month follow-up

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

Massachusetts General Hospital

Collaborator

Massachusetts Institute of Technology

Collaborator

University of Washington

Collaborator

Brown University

Collaborator

Source ClinicalTrials.gov
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