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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
171 Previous Clinical Trials
1,331,579 Total Patients Enrolled
Spaulding Clinical Research LLCOTHER
22 Previous Clinical Trials
1,273 Total Patients Enrolled
Leiden UniversityOTHER
33 Previous Clinical Trials
8,436 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 A: Placebo, Treatment B: Paroxetine, Treatment C: Escitalopram
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any documented risk associated with concurrent use of Paroxetine and Oxycodone?

"Paroxetine and Oxycodone being tested in this Phase 1 trial are believed to be of low risk, resulting in a score of 1. As such, there is only limited evidence supporting their safety or efficacy."

Answered by AI

How many individuals are engaging in this research effort?

"Affirmative. Clinicaltrials.gov details that this medical trial, which was initially shared on September 1st 2022, is actively recruiting participants. 25 people need to be recruited from a single location."

Answered by AI

Is there still an opportunity to enroll for this clinical trial?

"Clinicaltrials.gov shows that this research trial is actively searching for participants, having been first listed on September 1st 2022 and recently modified on October 19th of the same year."

Answered by AI

What is the primary aim of this clinical experiment?

"The goal of this medical study is to measure the Minute ventilation at 55mm Hg end tidal CO2 (VE55) under hyperoxic conditions on day 21 over a 5 hour period. Secondary outcomes include VE55 values for days 11 and 5, as well comparing escitalopram or paroxetine with oxycodone against oxycodone alone on day 12. Regression analysis will be conducted between minute ventilation levels and partial pressure of end tidal CO2 (PETCO2), followed by comparison using linear mixed effects model - all occuring within a five-hour window on each designated date."

Answered by AI

Is the age restriction for this clinical trial limited to those who are over thirty years old?

"This clinical trial is only available for individuals aged between 18 and 50, as 31 studies are being conducted on those younger than 18, while 164 trials focus on people over 65."

Answered by AI

Might I be eligible to participate in this clinical investigation?

"The clinical trial is inviting 25 persons aged 18-50 with hypercapnia who meet the following criteria to apply: Institutional Review Board (IRB) approved written informed consent, non-smoking status and body mass index of 18.5 - 33.0 kg/m2, standard medical history findings & laboratory results, negative test result for alcohol or drugs of abuse at screening & check-in days, SARS-CoV-2 rapid antigen testing at check-in; female participants must be non childbearing potential confirmed by a follicle stimulating hormone level > 40 mIU/mL or practice two highly effective methods of birth control"

Answered by AI
Recent research and studies
~10 spots leftby Apr 2025