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

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maimonides Medical Center
• Treatments: Ketamine

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