A Pilot Study to Assess the Efficacy of Subanesthetic Doses of IV Ketamine in the Treatment of Drug Resistant Epilepsy

What this Trial Is About

Researchers are evaluating subanesthetic doses of intravenous ketamine as a treatment option for adults with drug resistant epilepsy who continue to have seizures despite medication. Ketamine, historically used as an anesthetic and recently approved for drug resistant depression, has not been studied in low doses for outpatient seizure control. The study aims to assess ketamine's effectiveness in reducing seizures and improving mood in this patient group. The study is an open-label pilot with three phases. During screening, participants keep a seizure diary for 4 weeks and must have at least 4 seizures in that period to enter treatment. The treatment phase involves six visits over two weeks where patients receive 0.5 mg/kg of ketamine intravenously over 40 minutes three times a week. After treatment, participants undergo five safety assessments and three follow-up phone calls up to 18 weeks to monitor seizures and mood. Participants will be closely monitored through seizure diaries and mood assessments using standardized questionnaires such as the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E), Quality of Life in Epilepsy (QOLIE-10), and General Anxiety Disorder 7-item questionnaire (GAD-7). Researchers will measure seizure reduction during treatment and up to three months after infusion. Safety evaluations and adverse event assessments are conducted during and after treatment to ensure participant well-being throughout the study.

The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy