NCT05232032 Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Pharmacological Manipulation
| NCT ID | NCT05232032 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mclean Hospital |
| Condition | Depressive Disorder, Major |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 112 participants in total. It began in 2025-02-01 with a primary completion date of 2027-03-31.
⚠ 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
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
Inclusion criteria for MDD/anxiety disorder group: * 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 * Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment) * Absence of any psychotropic medications for at least 2 weeks (6 weeks for fluoxetine, 6 months for neuroleptics, 2 weeks for benzodiazepines, 2 weeks for any other antidepressants) Inclusion criteria for healthy controls: * Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (diagnosed using the SCID-5) * Written informed consent * Right-handed * Absence of any medications for at least 3 weeks * Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment) Exclusion criteria for all participants: * 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 * History or current diagnosis of any of the following DSM-IV psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, obsessive-compulsive disorder, patients with mood congruent or mood incongruent psychotic features, substance dependence, substance abuse within the last 12 months (with the exception of cocaine or stimulant abuse; which will lead to exclusion) * History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine) * History of use of dopaminergic drugs (including methylphenidate) * History or current diagnosis of dementia * 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 * Failure to meet standard magnetic resonance imaging safety requirements * Abnormal ECG and lab results * History of seizure disorder or currently on anticonvulsants
Contact & Investigator
Diego Pizzagalli, Ph.D.
PRINCIPAL INVESTIGATOR
Mclean Hospital
Frequently Asked Questions
Who can join the NCT05232032 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Depressive Disorder, Major. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05232032 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05232032 currently recruiting?
Yes, NCT05232032 is actively recruiting participants. Contact the research team at ezhang24@mclean.harvard.edu for enrollment information.
Where is the NCT05232032 trial being conducted?
This trial is being conducted at Belmont, United States.
Who is sponsoring the NCT05232032 clinical trial?
NCT05232032 is sponsored by Mclean Hospital. The principal investigator is Diego Pizzagalli, Ph.D. at Mclean Hospital. The trial plans to enroll 112 participants.