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
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