NCT05615948CompletedPhase 4
Oral Aspirin + Ketamine as Adjunct to Oral Antidepressant Therapy for Depression
An Open-Label Clinical Trial of Simultaneous Administration of Oral Aspirin and Ketamine as Adjunct to Oral Antidepressant Therapy in Treatment-Resistant Depression
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 31 Oct 2022
- Start date
- 6 Dec 2022
- Primary completion date
- 17 May 2024
- Lead sponsor
- Theresa Jacob, PhD, MPH
- Diseases
- Depression
- NCT number
- NCT05615948
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 15
- From 6 Dec 2022 to the primary completion date, 17 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Lithium Therapy
- Previous participation in this study; a patient may not re-enroll in another study while in this study
Other illness
- 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
- History of Gastrointestinal hemorrhage, renal and hepatic insufficiency
- Allergy to Ketamine or Aspirin
- Active Substance Abuse Disorder
- Active Peptic Ulcer Disease
Other
- Adult patients with recent or current suicidal ideation with an intent to act, homicidal ideations with an intent to act
- 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),
- Active psychosis
- Swallowing difficulty
- Consumption of Aspirin or NSAID's within 6 hours of arrival to the site
- Pregnant or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maimonides Medical Center Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.