Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Pharmacological Manipulation
Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Study 1.1. (Pharmacological Manipulation)
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
Not stated in the study description — ask the study team about visits and procedures.
- 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 tests whether a drug that blocks a brain receptor called NOPR can help with brain activity and choices about approaching or avoiding things. It is for people with depression or certain anxiety disorders who are not taking mental health medicines, and for healthy volunteers.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- For the depression/anxiety group: have major depression, generalized anxiety, social anxiety, panic disorder, or post-traumatic stress disorder, confirmed by a study interview.
- For people with depression: score above 16 on the study’s depression rating scale.
- For the depression/anxiety group: no mental health medicines for at least 2 weeks; at least 6 weeks for fluoxetine and 6 months for antipsychotic medicines.
- For healthy volunteers: no medical, brain, nerve, or mental health illness, including alcohol or drug abuse, based on health history and an interview.
- For healthy volunteers: no medicines for at least 3 weeks.
- Be right-handed.
- Have an iPhone or Android smartphone for study assessments.
- Give written consent to join.
Who can't join
- Suicidal thoughts that make care outside a hospital unsafe, according to the study clinician.
- Pregnant, or able to become pregnant but not using medically accepted birth control.
- Serious or unstable illness; a history of seizures; current seizure medicines; dementia; or signs of an underactive thyroid.
- A history or current diagnosis of bipolar disorder, obsessive-compulsive disorder, mental illness caused by a medical condition, or disorders with psychosis, such as schizophrenia. Psychosis can involve seeing things or believing things that are not real.
- A history or current diagnosis of drug or alcohol dependence, or abuse in the past 12 months; any past cocaine or stimulant use.
- Any past use of medicines that affect dopamine, a brain chemical, including methylphenidate; or current use of other mental health medicines.
- Any past electroconvulsive therapy, a treatment that uses electrical pulses to the brain.
- Cannot safely have an MRI scan, or have abnormal blood or other lab tests or an abnormal ECG, a test of the heart’s electrical activity.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
MA
- Mclean Hospital · Belmont, MA 02478Ethan Zhang, BA · Study contact · 617-855-4434 · ezhang24@mclean.harvard.eduDavid Crowley, ALM · Study contact · djcrowley@mclean.harvard.eduMore trials in Belmont