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Recruiting NCT05615948

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

Conditions: Treatment Resistant Depression, Major Depressive Disorder, Analgesia, Ketamine, Peripheral Nervous System Agents, Central Nervous System Depressants, Neurotransmitter Agents, Anti-Inflammatory Agents, Physiological Effects of Drugs, Sensory System Agents, Analgesics, Non-Narcotic, Anti-Inflammatory Agents, Non-Steroidal, Depressive Symptoms

Sex: All
Ages: 18 Years – 89 Years
Phase: PHASE4
Enrollment: 20
Sponsor: Maimonides Medical Center

Location: United States

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.

Eligibility Criteria

Inclusion Criteria:Adult patients with Treatment Resistant Depression with Montgomery-Asberg Depression Rating Scale score >22 upon presentation to the clinicTreatment Resistant Depression is defined as Major Depressive Disorder that does not cease after at least 6 week trial of another class of antidepressantsUnipolar DepressionExclusion Criteria:Adult patients with recent or current suicidal ideation with an intent to act, homicidal ideations with an intent to actHistory of Bipolar Disorder, Obsessive Compulsive Disorder, antisocial personality disorder, borderline personality disorder, and congestive cardiac failureUncontrolled 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 hypertensionPatients 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 insufficiencyAllergy to Ketamine or AspirinActive Substance Abuse DisorderActive psychosisActive Peptic Ulcer DiseaseLithium TherapySwallowing difficultyConsumption of Aspirin or NSAID's within 6 hours of arrival to the sitePrevious participation in this study; a patient may not re-enroll in another study while in this studyPregnant or breastfeeding

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05615948). StuddyBuddy aggregates publicly available trial information.