CompletedPhase 4ketamine

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

Sponsored by Maimonides Medical Center

NCT ID
NCT05615948
Target Enrollment
15 participants
Start Date
2022-12-06
Est. Completion
2024-05-17

About This Study

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.

Conditions Studied

Treatment Resistant DepressionMajor Depressive DisorderAnalgesiaKetaminePeripheral Nervous System AgentsCentral Nervous System DepressantsNeurotransmitter AgentsAnti-Inflammatory AgentsPhysiological Effects of DrugsSensory System AgentsAnalgesics, Non-NarcoticAnti-Inflammatory Agents, Non-SteroidalDepressive Symptoms

Interventions

  • VTS-K

Eligibility

Age:18 Years - 89 Years
Healthy Volunteers:No
View full eligibility criteria
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

Study Locations (1)

Maimonides Medical Center
Brooklyn, New York, United States

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source

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