IntroductionSeveral studies have shown that ketamine, an NMDA receptor antagonist, represents a promising alternative in treating depression and suicide. The intranasal or intravenous use of ketamine, currently used, has limitations in terms of cost and complexity. The subcutaneous (SC) route may be an affordable alternative for the treatment of depression and suicidality.ObjectivesTo evaluate the response of SC ketamine (0,5 mg/kg) applications on depressive, anxiety, and suicide symptoms.MethodsA patient with unipolar depression and suicide attempt was submitted to 3 sessions of SC ketamine (0,5 mg/kg). The applications had 2 days of intervals. Clinical evaluations were measured by BDI, BSI, and BAI. The vital signs were monitored under 2 hours after injections and the potential side effects.ResultsChanges in measurement instruments according to applications can be seen in Tab 1:BDIBSIBAIApplication 1261418Application 2030000Application 3020000The average measurements of vital signs during 2 hours of monitoring for each application can be seen in Tab 2:BPHRRFOXECGNine measurements (average)123/8078,8617,5599%NPConclusionsThe use of SC ketamine showed remission in BDI, BSI and BAI, respectively demonstrated safety in use.Disclosure of InterestNone Declared
ObjectiveKetamine, an N-methyl D-aspartate (NMDA) receptor antagonist, can promote rapid action in the management of individuals with treatment-resistant depression (TRD) at sub-anesthetic doses. However, few studies have investigated the long-term use of ketamine administered intravenously (IV) and intranasally (IN). We report the design and rationale of a therapeutic trial for assessing the efficacy, safety, and tolerability of repeated-dose intramuscular (IM) ketamine vs. active treatment (escitalopram and aripiprazole) in TRD patients.MethodsA comparative, parallel-group, randomized double-blind trial assessing the efficacy, safety, and tolerability of acute (4 weeks) and maintenance (24 weeks) use of IM ketamine (0.75 mg/kg) vs. active control (escitalopram 15 mg and aripiprazole 5 mg) in individuals with moderate-severe intensity TRD (no psychotic symptoms) with or without suicide risk will be conducted. Patients with TRD (18–40 years) will be randomized and blinded to receive ketamine IM or active treatment at a 1:1 ratio for 4 weeks (active treatment) and 24 weeks (maintenance treatment). Subjects will be assessed using clinical scales, monitored for vital signs (VS) after application of injectable medication, and undergo neuropsychological tests. The primary outcome will be changed on the Montgomery-Åsberg Depression Rating Scale (MADRS) during the course of the trial. The study is in running.ResultsThis study can potentially yield evidence on the use of IM ketamine in the treatment of depressive disorders as an ultra-rapid low-cost therapy associated with less patient discomfort and reduced use of medical resources, and can elucidate long-term effects on different outcomes, such as neuropsychological aspects.ConclusionsThe trial can help promote the introduction of a novel accessible approach for the treatment of complex disease (TRD) and also allow refinement of its long-term use.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT04234776, identifier: NCT04234776.
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