112 Participants Needed

Nociceptin Receptor Antagonist for Depression

DC
JB
EP
EM
Overseen ByEthan M Zhang, BA
Prior Safety DataThis treatment has passed at least one previous human trial

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?

DP

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

I have been diagnosed with depression, anxiety, social phobia, panic disorder, or PTSD.
Written informed consent
My depression is moderate to severe, based on a specific test score.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive either a nociceptin receptor antagonist or placebo, followed by an approach/avoidance task and fMRI

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6-month and 12-month intervals

12 months
2 visits (in-person)

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?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants with MDD or an anxiety disorder receiving the nociceptin receptor antagonistExperimental Treatment2 Interventions
Group II: Healthy controls receiving the nociceptin receptor antagonistExperimental Treatment2 Interventions
Group III: Healthy controls receiving the placeboPlacebo Group1 Intervention
Group IV: Participants with MDD or an anxiety disorder receiving the placeboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials
221
Recruited
22,500+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

Massachusetts Institute of Technology

Collaborator

Trials
104
Recruited
12,810,000+

University of Washington

Collaborator

Trials
1,858
Recruited
2,023,000+

Brown University

Collaborator

Trials
480
Recruited
724,000+

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 DepressionThe 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 ...
5.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/26585287/
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 depressionDOR 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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