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Can an antidepressant stabilize blood pressure in septic shock?

NCT ID NCT05725837

Disease control Sponsor: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This phase 2 trial investigates whether paroxetine, a common antidepressant, can improve cardiovascular function in patients with septic shock. Septic shock causes dangerously low blood pressure and poor response to standard vasopressor drugs. The study will give paroxetine or a placebo to 130 adults with septic shock for up to five days, measuring how long they need vasopressors and their overall heart and blood vessel function. The goal is to see if paroxetine can help restore blood pressure control and reduce the duration of intensive support.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Paroxetine, an antidepressant, given at 40 mg/day for 5 days or until shock resolves.
What this could lead to
If effective, paroxetine could become a new treatment to stabilize blood pressure in septic shock, reducing the need for vasopressors and potentially improving recovery.
What could go wrong
This is an early-phase trial with a modest size, so results may not be conclusive. Paroxetine can have side effects, and its benefit in sepsis is unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

130 people

The number who actually took part.

Started

Jun 2023

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient over 18 years of age; * Patient diagnosed with septic shock for less than 48 hours and using a minimum dose of noradrenaline (0.01 mcg/kg/min); * Patients and/or legal guardians who consented to participate in the study through the free and informed consent term before randomization. Exclusion Criteria: * Pregnant women; * Patients with inability to use the gastrointestinal tract; * Patients with known intolerance to paroxetine and/or fluoxetine; * Patients on concomitant use of medications that may potentiate the occurrence of serotonin syndrome (tramadol, citalopram, escitalopram, sertraline, desvenlafaxine, venlafaxine, duloxetine, sibutramine, bupropion, amitriptyline, nortriptyline, lithium); * Patients in end-of-life care or with an expected survival of less than 24 hours at the time of eligibility

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis Sepsis toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sepsis Septic shock

Contacts and locations

Locations

  • Hospital Maternidade São José de Colatina

    Colatina, Espírito Santo, Brazil

  • Hospital São José

    Criciúma, Santa Catarina, 88801460, Brazil

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