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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
Study Summary
This trial will test if adding low-dose buprenorphine to standard depression treatment can reduce suicidal thoughts by studying brain activity.
Eligible Conditions
- Depression
- Suicidal Thoughts
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Beck Scale for Suicidal Ideation (SSI) scores from pre- to Week 2 post-treatment.
Secondary outcome measures
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
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Who is running the clinical trial?
New York State Psychiatric InstituteLead Sponsor
475 Previous Clinical Trials
153,655 Total Patients Enrolled
82 Trials studying Depression
10,722 Patients Enrolled for Depression
Jeffrey M Miller, MDPrincipal InvestigatorNew York State Psychiatric Institute
2 Previous Clinical Trials
52 Total Patients Enrolled
2 Trials studying Depression
52 Patients Enrolled for Depression
Mina M Rizk, MDPrincipal InvestigatorNew York State Psychiatric Institute
1 Previous Clinical Trials
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