A double blind, randomized clinical trial assessing the efficacy and safety of augmenting standard antidepressant therapy with nimodipine in the treatment of ?vascular depression?

2001 ◽  
Vol 16 (3) ◽  
pp. 254-260 ◽  
Author(s):  
Fernando E. Taragano ◽  
Ricardo Allegri ◽  
Augusto Vicario ◽  
Pablo Bagnatti ◽  
Constantine G. Lyketsos
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Antidepressant Therapy ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Vascular Depression

A double-blind, randomized clinical trial to assess the augmentation with nimodipine of antidepressant therapy in the treatment of “vascular depression”

2005 ◽  
Vol 17 (3) ◽  
pp. 487-498 ◽  
Author(s):  
F. E. Taragano ◽  
P. Bagnatti ◽  
R. F. Allegri
Keyword(s):  
Clinical Trial ◽  
Cerebrovascular Disease ◽  
Randomized Clinical Trial ◽  
Antidepressant Therapy ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Number Needed To Treat ◽  
Double Blind ◽  
Vascular Depression ◽  
Full Remission

Background: Cerebrovascular disease may cause “vascular depression” (VaD). Calcium-channel blockers are presumed treatments for cerebrovascular disease and might be expected to improve depression and prevent recurrence.Objective: To examine the efficacy and tolerability of the use of nimodipine as an augmentation of fluoxetine in the treatment of VaD.Design: A double-blind, randomized clinical trial in which 101 patients with VaD (Alexopoulos criteria) were treated with fluoxetine at standard doses. Patients were randomized to placebo (n=51) or nimodipine (n=50). Treatment outcomes were assessed using the Hamilton Depression Rating Scale (HDRS) regularly up to 8 months after treatment initiation.Results: Depression was reduced in 63% of patients, but those whose treatment was enhanced with nimodipine had greater improvements overall by repeated measures analysis of covariance (ANCOVA) (F(1.80)=9.76, p=0.001). In addition, a greater proportion of patients treated with fluoxetine–nimodipine (54% vs. 27%) exhibited full remission (χ2(d.f. 1)=7.3, p=0.006), with the number needed to treat (NNT) equal to 4 (95% CI 2–12). Of those experiencing full remission in the first 61 days, fewer patients on fluoxetine–nimodipine (3.7%) developed recurrence of major depression as compared to those on fluoxetine alone (35.7%) (χ2(d.f. 1)=7.56, p=0.006), NNT 3 (95% CI 2–9). Side-effects were noted in 33.3% of patients in the control group and 48% of the experimental group (χ2(d.f. 1)=2.25, p=0.133).Conclusions: In treating VaD, augmentation of fluoxetine with nimodipine led to better treatment results and lower rates of recurrence. These findings support the argument that augmentation of antidepressant therapy might be helpful in the treatment of cerebrovascular disease, which is involved in the pathogenesis of this type of depression.

scholarly journals Correction to: Efficacy and safety of duloxetine and Pregabalin in Iranian patients with diabetic peripheral neuropathic pain: a double-blind, randomized clinical trial

2019 ◽  
Vol 18 (2) ◽  
pp. 583-583
Author(s):  
Khojasteh Joharchi ◽  
Moosareza Memari ◽  
Eznollah Azargashb ◽  
Navid Saadat
Keyword(s):  
Clinical Trial ◽  
Neuropathic Pain ◽  
Randomized Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Peripheral Neuropathic Pain ◽  
Iranian Patients

The article Efficacy and safety of duloxetine and Pregabalin in Iranian patients with diabetic peripheral neuropathic pain: a double-blind, randomized clinical trial, written by Khojasteh Joharchi, Moosareza Memari, Eznollah Azargashb, and Navid Saadat, was originally published.

Treatment of acute respiratory viral infections: results of a multicenter, double-blind, placebo-controlled, randomized clinical trial

2020 ◽  
Vol 18 (3) ◽  
pp. 178-189
Author(s):  
V.V. Rafalsky ◽  
◽  
R.F. Khamitov ◽  
T.I. Martynenko ◽  
M.V. Chernogorova ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Viral Infections ◽  
Wilcoxon Test ◽  
Controlled Study ◽  
Control Group ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Respiratory Viral Infections

This multicenter, double-blind, placebo-controlled clinical trial was conducted to obtain additional data on the efficacy and safety of Anaferon for the treatment of acute respiratory viral infections (ARVI) during seasonal increase in their incidence (RCT of the Ministry of Health of Russia No 356 dated 24.07.2018; ClinicalTrials.gov Identifier: NCT03707912). Patients and methods. Between October 2018 and March 2019, a total of 204 patients aged 18 to 70 years with ARVI symptoms were included in this study within the first 24 hours of symptom onset. Patients were randomized into 2 groups: 104 individuals received oral Anaferon (should be kept in the mouth until completely dissolved and without food) according to the following scheme: 1 tablet every 30 minutes during the first 2 hours; then 3 more doses at regular intervals during the first day; then 1 tablet 3 times a day on days 2–5; 100 individuals received placebo according to the same scheme. The primary endpoint was time to resolution of symptoms of clinically diagnosed and/or PCR (polymerase chain reaction) – confirmed ARVI. Addithional endpoints included: time to resolution of symptoms of ARVI confirmed by PCR; proportion of patients with resolution of symptoms of clinically diagnosed and/or PCR-confirmed ARVI and separately PCR-confirmed ARVI; severity of clinically diagnosed and/or PCR-confirmed ARVI (assessed by ‘area under the curve’ for the total severity index); the number of antipyretic doses taken according to indications on days 1–3 of treatment (checked in the patient's diary); proportion of patients who required antibiotic treatment on days 4–7 of follow-up. To assess safety, we analyzed the incidence and type of adverse events (AEs), their severity, association with drug use, and treatment outcome. The following statistical methods were used: Fisher's exact test, Cochran–Mantel–Haenszel test, Wilcoxon test, and repeated measures ANOVA, PROC MIXED. Results. A total of 203 patients were included in the intention-to-treat (ITT) and per protocol (РР) analysis: 103 [95] individuals in the Anaferon arm and 100 [93] individuals in the Placebo arm. Patients receiving Anaferon had significantly shorter time to resolution of all ARVI symptoms than patients receiving placebo: 4.1 ± 1.6 days vs 4.5 ± 1.5 days (p = 0.032). The disease was on average 1 day shorter in patients from the experimental group compared to controls: 3.6 ± 1.5 days vs 4.6 ± 1.5 days (p = 0.007). The proportion of patients who had resolution of symptoms of clinically diagnosed and/or PCR-confirmed ARVI was significantly higher in the Anaferon arm compared to Placebo arm (p = 0.0012). Among patients with PCR-verified ARVI, treatment with Anaferon resulted in twice as frequent recovery as in the control group on day 4 (53.7% vs 26.3%) and day 7 (70.7% vs 36.8%). In the Anaferon arm, we observed shorter disease duration and higher proportion of patients recovered compared to the Placebo arm; however, patients in both groups had a similar need for antipyretic drugs on days 1–3 of treatment, as well as for antibiotic therapy. The incidence of AEs in the Anaferon and Placebo groups did not vary significantly. No AEs with a reliable association with Anaferon were registered. Conclusion. Our findings suggest high efficacy and safety of Anaferon in patients with ARVI. The best results were obtained in patients with PCR-verified diagnosis, which can be attributed to the involvement of the interferon system in the action of the drug. The results of this RCT confirm the data obtained in previous studies and long-term clinical experience of using Anaferon. Key words: acute respiratory viral infections, ARVI, treatment, effective therapy, placebo-controlled study, Anaferon, randomized clinical trial, comprehensive therapy, efficacy, safety

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