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CompletedPhase 4

Oral Aspirin + Ketamine as Adjunct to Oral Antidepressant Therapy for Depression

NCT05615948 · Theresa Jacob, PhD, MPH

Closed to entry
Status
Not accepting participants
Phase 4
Phase
15
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The purpose of this study is to assess the effects of simultaneous administration of oral aspirin and oral ketamine as a therapeutic for those with Treatment Resistant Depression.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS).

    Measured over 7 Days

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 89 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Adult patients with Treatment Resistant Depression with Montgomery-Asberg Depression Rating Scale score \>22 upon presentation to the clinic * Treatment Resistant Depression is defined as Major Depressive Disorder that does not cease after at least 6 week trial of another class of antidepressants * Unipolar Depression Exclusion Criteria: * Adult patients with recent or current suicidal ideation with an intent to act, homicidal ideations with an intent to act * History of Bipolar Disorder, Obsessive Compulsive Disorder, antisocial personality disorder, borderline personality disorder, and congestive cardiac failure * Uncontrolled hypertension (BP \>140 mm Hg systolic and/or \>90 mm Hg diastolic on two separate readings at the time of screening) or on 2 medications for hypertension * Patients with unstable vital signs (systolic blood pressure \<90 or\>160 mm Hg, pulse rate \<50 or \>150 beats/min, and respiration rate \<10 or \>30 breaths/min), * History of Gastrointestinal hemorrhage, renal and hepatic insufficiency * Allergy to Ketamine or Aspirin * Active Substance Abuse Disorder * Active psychosis * Active Peptic Ulcer Disease * Lithium Therapy * Swallowing difficulty * Consumption of Aspirin or NSAID's within 6 hours of arrival to the site * Previous participation in this study; a patient may not re-enroll in another study while in this study * Pregnant or breastfeeding

Where

1 study site

FacilityCityRegionCountry
Maimonides Medical CenterBrooklynNew YorkUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05615948 on ClinicalTrials.gov →

Last updated in the registry 2026-04-21. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits