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Belbuca Buccal Product for Depression

Phase 3
Waitlist Available
Led By Jeffrey M Miller, MD
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

Summary

This trial tests if adding low-dose buprenorphine to usual treatments can help reduce suicidal thoughts in people with major depression who haven't responded well to standard antidepressants. Buprenorphine may work by changing brain activity related to negative emotions, potentially offering faster relief from suicidal thoughts. Buprenorphine has shown potential antidepressant effects, particularly in treatment-resistant depression (TRD).

Eligible Conditions
  • Depression
  • Suicidal Thoughts

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in Beck Scale for Suicidal Ideation (SSI) scores from pre- to Week 2 post-treatment.
Secondary study objectives
Changes in functional magnetic resonance imaging (fMRI) blood oxygen- level dependent (BOLD) signal in the amygdala in response to negative vs. neutral pictures from pre- to Week 2 post-treatment

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BuprenorphineExperimental Treatment1 Intervention
Buccal Films
Group II: PlaceboPlacebo Group1 Intervention
Buccal Films

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
477 Previous Clinical Trials
154,028 Total Patients Enrolled
83 Trials studying Depression
10,972 Patients Enrolled for Depression
Jeffrey M Miller, MDPrincipal InvestigatorNew York State Psychiatric Institute
2 Previous Clinical Trials
50 Total Patients Enrolled
2 Trials studying Depression
50 Patients Enrolled for Depression
Mina M Rizk, MDPrincipal InvestigatorNew York State Psychiatric Institute
1 Previous Clinical Trials
~0 spots leftby Sep 2025
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