ABSTRACT
Objective: As glutamatergic system dysfunction is involved in bipolar depression pathophysiology, the glutamate receptor modulators such as Ketamine have been applied as complementary medication for mood stabilizers. While the treatment is currently just the intravenous injection of a single dose, and there is no robust conclusion on Ketamine effectiveness or its side effects in bipolar patients, this study aimed to consider single- and double-dose intravenous injections of Ketamine in bipolar patients compared to the placebo. Method : In a randomized, double-blind controlled clinical trial, 30 patients diagnosed with bipolar I and II disorders according to DSM-IV-TR (SCID-I) were randomly divided into three groups: the first group received an intravenous injection of Ketamine (0.5 mg/kg) and placebo with a three-day interval, the second group received two doses of Ketamine (0.5 mg/kg) in the same interval, and the third group received two placebo injections. Patients were assessed for depression, anxiety, and mania at various time points, including before the injection, 60 minutes after the injection, on the first, third, fifth, seventh, and 14th day, as well as at the end of the first month using the Hamilton Depression Rating Scale, Beck Anxiety Inventory, and Young Mania Scale, respectively. Data were analyzed using ANOVA and Repeated measure tests. Results: The mean age of patients was 36.8 ± 7.9 years, with 18 females (60%) and 12 (40%) males. Depression and anxiety showed significant differences in both the single- and double-dose Ketamine groups over time (P < 0.01). Moreover, mania displayed significant changes during the study time in the single- and double-dose Ketamine groups, as well as the in the control group. However, during the study time, there were no significant differences observed in depression, anxiety, and mania among the three groups (P = 0.198, P = 0.416, and P = 0.540, respectively). Patients did not indicate any side effects during the study. Conclusion: Intravenous Ketamine administration may relieve depressive manifestations in bipolar patients. The findings suggest that a double dose of Ketamine does not lead to greater improvement than a single dose.
ABSTRACT
Coronavirus disease 2019 (COVID-19) pandemic has caused an urgent need for investigating potential treatments. Traditional medicine offers many potential remedies that have been historically used and have the advantage of bypassing the cultural obstacles in the practice of medicine. We aimed to investigate the efficacy of Zufa syrup in the treatment of suspected patients with mild to moderate symptoms of COVID-19. This triple-blind randomized controlled trial recruited patients with evidence of COVID-19 on chest computed tomography without an indication of hospital admission from March 2020 until April 2020. Participants were assessed by a physician and completed a pre-specified form to assess the duration and severity of symptoms. Patients were randomized to receive Zufa syrup (a combination of herbal medicines: Nepetabracteata, Ziziphus jujube, Glycyrrhizaglabra, Ficuscarica, Cordia myxa, Papaver somniferum, Fennel, Adiantumcapillus-veneris, Viola, Viper's-buglosses, Lavender, Iris, and sugar) or identical-looking placebo syrup at a dose of 7.5 mL (one tablespoon) every 4 hours for 10 days. After applying the eligibility criteria, 116 patients (49.1% male) were randomized to trial arms with a mean age of 44.3. During the follow-up, Cough, dyspnea, headache, myalgia, anorexia, anxiety, and insomnia improved gradually in both groups, and showed no difference between Zufa syrup and placebo. Oxygen saturation and pulse rate had stable trends throughout the follow-up and were similar between study arms. No patient required hospital admission or supplemental oxygen therapy during the study period. To conclude, in patients with mild to moderate symptoms of COVID-19, Zufa syrup did not show any difference in symptomatology over a 10 days' period when compared with placebo. Due to potential effects of medicinal plants in the treatment of respiratory infections, further studies are warranted to clarify their role in COVID-19. The study was approved by the Ethics Committee of the Qom University of Medical Science (Ethics committee reference number IR.MUQ.REC.1398.165) on March 10, 2020 and was registered in Iranian Clinical Trial Center (approval ID: IRCT20200404046934N1) on April 13, 2020.
