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Anti-suicidal Effects of Buprenorphine In Depressed Individuals | Clinical Trials | Clareo Health

WITHDRAWNPHASE3

Anti-suicidal Effects of Buprenorphine In Depressed Individuals

Functional Brain Mechanisms Underlying the Anti-Suicidal Effects of Low-dose Buprenorphine in Major Depression

NCT05427981•New York State Psychiatric Institute

Summary

This study aims to examine the effect of low-dose buprenorphine as an add-on to treatment-as-usual for suicidal ideation in individuals with major depression, and investigate the functional brain activity related to its potential anti-suicidal effect.

Detailed Description

Buprenorphine is an approved treatment for pain and opioid relapse prevention. Buprenorphine has recently shown promise in the treatment of depression and suicidal ideation relatively faster than currently available antidepressants, but its mechanisms in treating these conditions are unknown. Buprenorphine activates the mu opioid receptor in the brain and blocks the kappa opioid receptor. Activation of the mu receptors produces pleasant emotions while the kappa receptors are linked to dysphoria and other negative emotional states. By blocking kappa receptors, buprenorphine may reduce negative emotions and improve suicidal thoughts. In this project, we will compare buprenorphine to placebo as adjunctive to usual treatments for patients who still have depression and suicidal thoughts despite being treated with adequate antidepressant medications for at least 4 weeks. We hypothesize that suicidal ideation will decrease after two weeks of treatment in the buprenorphine group relative to the placebo group. Using functional magnetic resonance imaging, we will also examine the effects of buprenorphine on the activity of brain regions involved in the brain's response to negative emotions and test whether these effects are associated with the reduction in suicidal thoughts. This would provide some evidence that the antidepressant and anti-suicidal effects of buprenorphine are related to its kappa opioid receptor blockade. The mechanism of action of buprenorphine is different from the currently available antidepressants. This study will help understand this mechanism which may help refine the use of buprenorphine in this context. Research in this area may also facilitate the development of new anti-suicidal treatments (i.e., other opioid-active compounds).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•In order to be eligible to participate in this study, an individual must meet all of the following criteria:
•1. Provision of signed and dated informed consent form.
•2. Stated willingness to comply with all study procedures and availability for the duration of the study.
•3. Male or female.
•4. Aged 18-65 years.
•5. Ability to take oral medication and be willing to adhere to the treatment regimen.
•6. Current major depressive episode.
•7. Hamilton Depression Rating Scale (HDRS) Score \> 16.
•8. Active suicidal ideation (Columbia Suicide Severity Rating Scale (C-SSRS) of 3 or more).
•9. Participants must have been on a medication regimen for depression that includes an adequate dose of antidepressant for at least the past 4 weeks.

Exclusion Criteria

•An individual who meets any of the following criteria will be excluded from participation in this study:
•1. Current active psychosis or mania.
•2. Current or past alcohol use disorder or substance use disorder involving any prescribed or any illicit drug (opioid, benzodiazepine, or other drug use) including mild severity.
•3. Family history of alcohol or substance use disorder in a first-degree relative.
•4. Current or past history of prescription or non-prescription opioid use.
•5. History of other risk factors for the development of opioid misuse and opioid use disorder other than comorbid depression (e.g., homelessness, criminal record, aggressive or violent behavior that resulted in injury to another person).
•6. Current acute or chronic pain.
•7. Neurological disorders (e.g., epilepsy, brain tumors or patients with increased intracranial pressure due to other reasons).
•8. A history of prior head trauma with evidence of cognitive impairment. Participants who endorse a history of prior head trauma will be administered the Trail-making A and B test. Those who score 1.5 standard deviations below the mean on the Trail-making A or B will be excluded from study participation.
•9. Active significant medical illness that would make study participation hazardous to the participant or compromise study findings or would prevent the participant from completing the study (e.g., oral mucositis, orthostatic hypotension, history of hypotensive disorders, hypokalemia, hypomagnesemia, or clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia, history of Long QT syndrome or immediate family member with this condition, moderate to severe hepatic impairment or hepatitis, liver cirrhosis , severe chronic pulmonary diseases, significant respiratory depression, acute or severe bronchial asthma, known or suspected gastrointestinal obstruction, including paralytic ileus).
+8 more criteria

Locations (1)

New York State Psychiatric Institute

New York, New York, United States

Key Dates

Start Date

October 10, 2022

Primary Completion Date

January 14, 2024

Completion Date

January 14, 2024

Last Updated

November 14, 2023

Conditions

Suicidal IdeationMajor Depressive Disorder

Interventions

Belbuca Buccal Product

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Anti-suicidal Effects of Buprenorphine In Depressed Individuals

Inclusion Criteria

Exclusion Criteria

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