Nociceptin Receptor Antagonist for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment aimed at helping people with major depressive disorder (MDD) and anxiety by improving decision-making processes in the brain. It involves a nociceptin receptor antagonist, a drug that may regulate brain circuits linked to mood and behavior. Individuals diagnosed with MDD or an anxiety disorder who are not currently on medication might be suitable for this trial. Participants will receive either the new treatment or a placebo, and both groups will complete tasks to assess the treatment's impact on behavior and brain activity. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
Yes, you will need to stop taking your current medications. Participants must be off psychotropic medications for at least 2 weeks, with longer periods for certain drugs like fluoxetine (6 weeks) and neuroleptics (6 months).
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that a new treatment, nociceptin receptor antagonists, is being tested for depression and has shown promise in early studies. These studies suggest that the treatment may improve symptoms of depression. Importantly, participants have tolerated it well, with few reports of serious side effects. This indicates that the treatment might be safe for humans, though further research is needed to confirm these findings. As this trial is in an early phase, it primarily focuses on assessing the treatment's safety and understanding its effects better.12345
Why do researchers think this study treatment might be promising for depression?
Most treatments for depression and anxiety work by altering neurotransmitter levels, such as serotonin or dopamine, through medications like SSRIs or SNRIs. But the nociceptin receptor antagonist takes a different approach by targeting the nociceptin/orphanin FQ system, which is thought to play a role in mood regulation and stress response. This unique mechanism of action could offer a new pathway for treatment, potentially benefiting patients who don't respond well to existing therapies. Researchers are excited about this treatment because it opens up a novel method for addressing mood disorders, which could lead to more effective and faster-acting therapies for those in need.
What evidence suggests that this treatment might be an effective treatment for depression and anxiety?
Research has shown that a new treatment, the nociceptin receptor antagonist, might help with depression. This trial will evaluate its effects on participants with major depressive disorder (MDD), anxiety disorders, and healthy controls. The treatment targets specific brain areas involved in mood and decision-making. Animal studies have shown positive results, and one study found that it improved depression symptoms in people, as measured by standard tests. The treatment affects brain areas controlling mood and emotions and involves the opioid system, linked to both pain and mood. These findings suggest that this treatment could be effective for people with MDD and anxiety disorders.15678
Who Is on the Research Team?
Diego Pizzagalli, Ph.D.
Principal Investigator
Mclean Hospital
Are You a Good Fit for This Trial?
This trial is for right-handed individuals with major depressive disorder (MDD) or anxiety disorders, who are not on psychotropic medications and have no other medical, neurological, or psychiatric conditions. Participants must meet DSM-5 criteria, have a smartphone for assessments, and provide informed consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a nociceptin receptor antagonist or placebo, followed by an approach/avoidance task and fMRI
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 6-month and 12-month intervals
What Are the Treatments Tested in This Trial?
Interventions
- Nociceptin Receptor Antagonist
Trial Overview
The study tests if a nociceptin receptor antagonist can correct the neural and behavioral patterns related to approach/avoidance decisions in people with MDD or anxiety disorders by targeting specific brain circuitry and peptide receptors.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
After a diagnostic interview (determining the presence of MDD or an anxiety disorder) and collection of blood for Orphanin FQ/Nociceptin assays, participants will receive the nociceptin receptor antagonist. Participants will then complete an approach/avoidance task. Functional magnetic resonance imagining (fMRI) will begin 2 hours after the nociceptin receptor antagonist is administered.
After a diagnostic interview (determining healthy control status) and collection of blood for Orphanin FQ/Nociceptin assays, participants will receive a nociceptin receptor antagonist. Participants will then complete an approach/avoidance task. fMRI will begin 2 hours after the nociceptin receptor antagonist is administered.
After a diagnostic interview (determining healthy control status) and collection of blood for Orphanin FQ/Nociceptin assays, participants will receive the placebo. Participants will then complete an approach/avoidance task. fMRI will begin 2 hours after the placebo is administered.
After a diagnostic interview (determining the presence of MDD or an anxiety disorder) and collection of blood for Orphanin FQ/Nociceptin assays, participants will receive the placebo. Participants will then complete an approach/avoidance task. fMRI will begin 2 hours after the placebo is administered.
Find a Clinic Near You
Who Is Running the Clinical Trial?
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
Citations
Contribution of the opioid system to depression and ...
Opioids, historically used to alleviate pain, emerged as promising and effective therapeutic options in the treatment of depression.
Preclinical findings predicting efficacy and side‐effect profile ...
Furthermore, NOP receptor antagonists engender antidepressant-like effects in rodents (see full summaries on these data in Witkin et al. 2014a).
Nociceptin Receptor Antagonist for Depression
The study will investigate whether a nociceptin receptor antagonist will normalize neural and behavioral processes of approach/avoidance decision-making in ...
A Selective Nociceptin Receptor Antagonist to Treat ...
The results from the analysis of change from baseline in the GRID-HAMD-17 total score in the FAS revealed an improvement in depressive symptoms ...
A Selective Nociceptin Receptor Antagonist to Treat ...
In this study we demonstrate that targeting NOP receptors with LY2940094 translates to antidepressant-like effects in rodent models and, importantly, to ...
Pharmaco-Neuroimaging Studies of Approach/Avoidance ...
The study will investigate whether a nociceptin receptor antagonist will normalize neural and behavioral processes of approach/avoidance decision-making in ...
NEW AGENTS AND PERSPECTIVES IN THE ...
With a lifetime prevalence of 16%, it is associated with important psychological suffering, as well as elevated rates of suicide and worse prognosis of comorbid ...
The opioid system in depression
DOR selective agonists and KOR selective antagonists, may be viable treatment options for MDD, without the risk of addiction. •. Further work is needed to ...
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