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2 mg Melatonin for Anxiety

Phase 3
Waitlist Available
Led By Rick Fisher, DO
Research Sponsored by United States Naval Medical Center, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up anxiety levels will be assessed at check-in time (90 minutes before procedure), immediately before procedure, and 90 minutes post-operatively.
Awards & highlights

Study Summary

This trial is designed to study the effects of melatonin on reducing anxiety in patients before a lumbar medial branch block, a common interventional pain procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~anxiety levels will be assessed at check-in time (90 minutes before procedure), immediately before procedure, and 90 minutes post-operatively.
This trial's timeline: 3 weeks for screening, Varies for treatment, and anxiety levels will be assessed at check-in time (90 minutes before procedure), immediately before procedure, and 90 minutes post-operatively. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anxiety

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: 2 mg MelatoninActive Control1 Intervention
To remain within the doses used for anxiolytic effects in past studies, we plan to study the effects of 2mg melatonin.
Group II: 10 mg MelatoninActive Control1 Intervention
To remain within the doses used for anxiolytic effects in past studies, we plan to study the effects of 10mg melatonin.
Group III: Sugar PillPlacebo Group1 Intervention
To remain within the doses used for anxiolytic effects in past studies, we plan to study the effects of two different levels of melatonin versus placebo as premedication in patients undergoing a lumbar medial branch block (LMBB) procedure.

Find a Location

Who is running the clinical trial?

United States Naval Medical Center, San DiegoLead Sponsor
102 Previous Clinical Trials
22,691 Total Patients Enrolled
2 Trials studying Anxiety
136 Patients Enrolled for Anxiety
Rick Fisher, DOPrincipal InvestigatorUnited States Naval Medical Center, San Diego

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Sleep Medicine ReviewsJournal
Effects of Exogenous Melatonin on Sleep: A Meta-analysis
Brzezinski, Amnon, Mark G. Vangel, Richard J. Wurtman, Gillian Norrie, Irina Zhdanova, Abraham Ben-Shushan, and Ian Ford. 2005. “Effects of Exogenous Melatonin on Sleep: A Meta-analysis”. Sleep Medicine Reviews. Elsevier BV. doi:10.1016/j.smrv.2004.06.004.
Anesthesia & AnalgesiaJournal
The Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Moerman, Nelly, Frits S. A. M. van Dam, Martin J. Muller, and Hans Oosting. 1996. “The Amsterdam Preoperative Anxiety and Information Scale (APAIS)”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00000539-199603000-00002.
clinicaltrials.govStudy
Premedication With Melatonin in Lumbar Medial Branch Block Procedure
Eugene Smith 2016. "Premedication With Melatonin in Lumbar Medial Branch Block Procedure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02415309.
~3 spots leftby Apr 2025
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