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Selective Serotonin Reuptake Inhibitor

SSRIs + Opioid for Respiratory Insufficiency, Hypercapnia, and Respiratory Depression

Phase 1
Waitlist Available
Led By Jan Matousek, D.O.
Research Sponsored by Food and Drug Administration (FDA)
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 5 hours on day 21
Awards & highlights

Study Summary

This trial is designed to study the effects of combining the drugs paroxetine or escitalopram with an opioid on ventilation.

Eligible Conditions
  • Respiratory Depression
  • Hypercapnia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 hours on day 21
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 hours on day 21 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Minute ventilation at 55mm Hg end tidal CO2 (VE55) under hyperoxic conditions on day 21
VE55 under hyperoxic conditions on day 20
Secondary outcome measures
VE55 under hyperoxic conditions on day 11
VE55 under hyperoxic conditions on day 12
VE55 under hyperoxic conditions on day 5
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment C: EscitalopramExperimental Treatment1 Intervention
Participants will receive escitalopram on days 1-21 for this treatment period. Oxycodone will be administered on days 6, 12, and 21 of this treatment period.
Group II: Treatment B: ParoxetineExperimental Treatment1 Intervention
Participants will receive paroxetine on days 1-21 for this treatment period. Oxycodone will be administered on days 6, 12, and 21 of this treatment period.
Group III: Treatment A: PlaceboPlacebo Group1 Intervention
Participants will receive placebo on days 1-21 for this treatment period. Oxycodone will be administered on days 6, 12, and 21 of this treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paroxetine and Oxycodone
2022
Completed Phase 1
~30
Escitalopram and Oxycodone
2022
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Food and Drug Administration (FDA)Lead Sponsor
174 Previous Clinical Trials
1,333,665 Total Patients Enrolled
Spaulding Clinical Research LLCOTHER
22 Previous Clinical Trials
1,273 Total Patients Enrolled
Leiden UniversityOTHER
34 Previous Clinical Trials
8,536 Total Patients Enrolled

Media Library

Escitalopram (Selective Serotonin Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05470465 — Phase 1
Respiratory Depression Research Study Groups: Treatment C: Escitalopram, Treatment B: Paroxetine, Treatment A: Placebo
Escitalopram (Selective Serotonin Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05470465 — Phase 1
Respiratory Depression Clinical Trial 2023: Escitalopram Highlights & Side Effects. Trial Name: NCT05470465 — Phase 1
~10 spots leftby May 2025
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