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

This interventional trial (n=20) aims to assess the effects of simultaneous administration of oral aspirin and oral ketamine as an adjunct to oral antidepressant therapy for treatment-resistant depression (TRD).

Conducted by Maimonides Medical Center in Brooklyn, New York, the study evaluates the effect of oral aspirin and oral ketamine, formulated for partial release in the oral cavity and partially swallowed, on depressive symptoms in TRD patients. Participants, aged 18 years and older, with a diagnosis of TRD, will receive the intervention in three visits. The first two visits involve in-person administration of oral ketamine and oral aspirin, with vital signs monitored for at least two hours. The final visit will be conducted remotely.

Primary outcomes include changes in depressive symptoms measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to day 7. Secondary outcomes involve assessing depressive symptoms and side effects at various time points. The study, started in December 2022, is estimated to be completed by October 2023.

Trial Details

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.

NCT Number NCT05615948

Data attribution

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