Intramuscular ketamine vs. escitalopram and aripiprazole in acute and maintenance treatment of patients with treatment-resistant depression: A randomized double-blind clinical trial.

Objective: Ketamine, 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. Methods: A 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. Results: This 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. Conclusions: The 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 registration: https://clinicaltrials.gov/ct2/show/NCT04234776, identifier: NCT04234776.

Diagnosis and pharmacological treatment of depressive disorders in a general hospital.

OBJECTIVE: To determine the point prevalence of depressive disorders in medical inpatients, to identify related sociodemographic and medical factors and to evaluate the psychotropic treatment given. METHOD: A cross-sectional study identifying the prevalence of depressive disorders and related factors combined with a prospective longitudinal study evaluating the psychopharmacological treatment were conducted. Medical inpatients, aged 18 years or older, presenting suitability to be interviewed and giving written informed consent were selected. The sample was composed of 125 subjects. The following instruments were used: a sociodemographic questionnaire; the Mini International Neuropsychiatric Interview; and the Beck Depression Inventory. Data related to medical, personal and family histories of psychiatric disorders and psychotropic use were collected by interview and from patient charts. The study took place at the Hospital Santa Isabel, in Blumenau, located in the state of Santa Catarina, Brazil, from January to July of 2002. RESULTS: The prevalence of depressive disorders was 26%. The factors that correlated with depressive disorders were being female, having an income lower than 3 times the minimum wage, having a personal history of depressive disorders, using psychotropic drugs, scoring higher than 13 on the Beck Depression Inventory and having been referred for a psychiatric consultation (p < 0.05). Only 43.8% of the individuals with depressive disorders received antidepressants. Most of the depressed patients were being treated with benzodiazepines (62.5%). The most frequently prescribed drugs were diazepam and fluoxetine. CONCLUSIONS: Approximately one-quarter of the medical inpatients had depressive disorders. However, antidepressants were prescribed for less than half of them. Women with a history of depression, using benzodiazepines and having a low income presented significantly higher rates of depressive disorders. Physicians should suspect depression in patients presenting such characteristics.

Diagnosis and pharmacological treatment of depressive disorders in a general hospital

OBJETIVO: Identificar a prevalência de transtornos depressivos em pacientes internados em enfermarias clínicas de um hospital geral, avaliar o tratamento psicofarmacológico recebido e detectar fatores sociodemográficos e clínicos associados. MÉTODO: Realizou-se um estudo observacional transversal identificando a prevalência de transtornos depressivos e fatores associados juntamente com estudo longitudinal prospectivo avaliando o tratamento psicofarmacológico recebido durante a internação. Foram selecionados pacientes com mais de 18 anos, que apresentavam condições para a entrevista e que consentiram. A amostra foi composta por 125 pessoas. Aplicaram-se os seguintes instrumentos: questionário com variáveis sociodemográficas; coleta de informações sobre história médica, psiquiátrica e familiar; questionário sobre uso de psicofármacos; Mini International Neuropsychiatric Interview; e Inventário Beck de Depressão. O estudo realizou-se no Hospital Santa Isabel, Blumenau-SC, de janeiro a julho de 2002.RESULTADOS: A prevalência de transtornos depressivos foi de 26%. Somente 43,8% dos indivíduos com transtornos depressivos receberam antidepressivos. A maioria dos deprimidos utilizou benzodiazepínicos (62,5%). Dentre os psicofármacos, destacaram-se o diazepam e a fluoxetina. Fatores associados foram: sexo feminino, renda menor que três salários mínimos, história prévia de depressão, uso de psicofármacos, Inventário Beck de Depressão maior que 13 e pedido de interconsulta psiquiátrica (p < 0,05).CONCLUSÕES: Cerca de » dos pacientes internados em enfermaria clínicas de um hospital geral apresentaram diagnóstico de transtornos depressivos. Entretanto, menos da metade recebeu tratamento com antidepressivo. As mulheres com história prévia de depressão, baixa renda e em uso de benzodiazepínicos tiveram taxas significativamente maiores de transtornos depressivos. Os médicos deveriam suspeitar de transtornos depressivos em pacientes com essas características.