NCT05615948

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Maimonides Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objective of the study is to evaluate the effect of simultaneous administration of oral aspirin and oral ketamine, formulated for partial release in the oral cavity and partially swallowed, as an adjunct to the oral antidepressant on depressive symptoms in patients suffering from Treatment Resistant Depression (TRD) in outpatient Psychiatric Clinic. Investigators will evaluate the effects of simultaneous administration of oral aspirin and oral ketamine, on depressive symptoms. This is a prospective open-label, proof of concept clinical trial of simultaneous administration of proprietary formulations of oral aspirin and ketamine in medically stable adult patients with a diagnosis of Treatment Resistant Depression. All eligible participants will commit to three visits. The first two visits are in-person at the clinic for administration of oral ketamine and oral aspirin. Participants will be under observation for at least two hours. Study participant's vital signs will be monitored, periodically. The last visit will be conducted remotely. Adult patients 18 years of age and older, with a diagnosis of TRD presenting to the psychiatric clinic will be screened for enrollment by study team. :

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

Interventions

Type	Name	Description
DRUG	VTS-K	Proprietary oral formulation of 486mg aspirin and 80mg ketamine

Timeline

• Start date: 2022-12-06
• Primary completion: 2024-05-17
• Completion: 2024-05-17
• First posted: 2022-11-14
• Last updated: 2024-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study