scholarly journals The efficacy and safety of Anyu Peibo Capsule in the treatment of patients with major depressive disorder in China: study protocol for a randomized placebo-controlled trial

2021 ◽  
Author(s):  
Jingjing Huang ◽  
Yimin Yu ◽  
Yi Jiang ◽  
Wu Chen ◽  
Yan Li ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Controlled Trial ◽  
Efficacy And Safety ◽  
Phase Ii Trials ◽  
Major Depressive ◽  
Double Blinded ◽  
Favorable Safety ◽  
Be The Change

Abstract Background: Major depressive disorder is the second leading cause of year lost to disability worldwide. Anyu Peibo Capsule was shown to have certain effective and favorable safety in phase II trials.Methods: The clinical study is a multi-center, randomized, double-blinded, placebo-controlled, parallel groups phase Ⅲ trail of Anyu Peibo Capsule in China, to aim whether the administration of Anyu Peibo Capsule compared to placebo improves clinical outcome in adults (18 years to 65 years) with MDD. The subjects will receive 8-week treatment with Anyu Peibo Capsule 1.6 g per day or placebo. The primary outcome will be the change of total score from baseline to the end of week 8 in Montgomery Asberg Depression Rating Scale.Discussion: The trial aims to provide pivotal evidence on the efficacy and safety of Anyu Peibo Capsule in patients with major depressive disorder. Trial registration: ClinicalTrials.gov, NCT04210973. Registered on December 26, 2019. https://www.clinicaltrials.gov/ct2/show/NCT04210973 Protocol version 1.2 from 29 August 2019.

scholarly journals The efficacy and safety of Anyu Peibo Capsule in the treatment of patients with major depressive disorder in China: study protocol for a randomized placebo-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jingjing Huang ◽  
Yimin Yu ◽  
Yi Jiang ◽  
Wu Chen ◽  
Yan Li ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Controlled Trial ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Phase Ii Trials ◽  
Major Depressive ◽  
Link Type ◽  
Double Blinded

Abstract Background Major depressive disorder is the second leading cause of years lost to disability worldwide. Anyu Peibo Capsule has been shown to be effective and safe in phase II trials. Methods This clinical study is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group, phase III trial of Anyu Peibo Capsule in China. The aim is to test whether the administration of Anyu Peibo Capsule compared to placebo improves clinical outcomes in adults (aged 18 to 65 years) with MDD. Patients will receive an 8-week treatment of Anyu Peibo Capsule 1.6 g per day or placebo. The primary outcome will be the change from baseline in the total score for the Montgomery-Asberg Depression Rating Scale at the end of the 8-week treatment. Discussion The trial aims to provide pivotal evidence for the efficacy and safety of Anyu Peibo Capsule in patients with major depressive disorder. Trial registration ClinicalTrials.govNCT04210973. Registered on December 26, 2019

Duloxetine in the treatment of major depressive disorder: a placebo- and paroxetine-controlled trial

2006 ◽  
Vol 21 (6) ◽  
pp. 367-378 ◽  
Author(s):  
D.G.S. Perahia ◽  
F. Wang ◽  
C.H. Mallinckrodt ◽  
D.J. Walker ◽  
M.J. Detke
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Acute Phase ◽  
Rating Scale ◽  
Controlled Trial ◽  
Published Data ◽  
Efficacy And Safety ◽  
Major Depressive ◽  
Double Blind ◽  
Efficacy Measures

AbstractObjective:Duloxetine doses of 80 and 120 mg/day were assessed for efficacy and safety in the treatment of major depressive disorder (MDD).Methods:In this randomized, double-blind trial, patients age ≥ 18 meeting DSM-IV criteria for MDD were randomized to placebo (N = 99), duloxetine 80 mg/day (N = 93), duloxetine 120 mg/day (N = 103), or paroxetine 20 mg/day (N = 97). The primary outcome measure was mean change from baseline in the 17-item Hamilton rating scale for depression (HAMD17) total score after 8 weeks of treatment; a number of secondary efficacy measures also were assessed. Safety and tolerability were assessed via collection and analysis of treatment–emergent adverse events (TEAEs), vital signs, and weight. The Arizona sexual experiences scale was used to assess sexual functioning. Patients who had a ≥ 30% reduction from baseline in the HAMD17 total score at the end of the acute phase entered a 6-month continuation phase where they remained on the same treatment as they had taken during the acute phase; efficacy and safety/tolerability outcomes were assessed during continuation treatment.Results:More than 87% of patients completed the acute phase in each treatment group. Duloxetine-treated patients (both doses) showed significantly greater improvement (P < 0.05) in the HAMD17 total score at week 8 compared with placebo. Paroxetine was not significantly different from placebo (P = 0.089) on mean change on the HAMD17. Duloxetine 120 mg/day also showed significant improvement on most secondary efficacy measures (six of nine) compared with placebo while duloxetine 80 mg/day (three of nine) and paroxetine (three of nine) were significantly superior to placebo on fewer secondary measures. HAMD17 mean change data from this study and an identical sister study were pooled as defined a priori for the purposes of performing a non-inferiority test versus paroxetine. Both duloxetine doses met statistical criteria for non-inferiority to paroxetine. TEAE reporting rates were low in all treatment groups and no deaths occurred in the acute or continuation phases.Conclusions:The efficacy of duloxetine at doses of 80 and 120 mg/day in the treatment of MDD was demonstrated. Tolerability, as measured by TEAEs, and safety were similar to paroxetine 20 mg/day and consistent with previous published data on duloxetine in the treatment of MDD.

Adjunctive minocycline treatment for major depressive disorder: A proof of concept trial

2017 ◽  
Vol 51 (8) ◽  
pp. 829-840 ◽  
Author(s):  
Olivia M Dean ◽  
Buranee Kanchanatawan ◽  
Melanie Ashton ◽  
Mohammadreza Mohebbi ◽  
Chee Hong Ng ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Major Depressive Disorder ◽  
Confidence Interval ◽  
Depressive Disorder ◽  
Clinical Global Impression ◽  
Effect Size ◽  
Rating Scale ◽  
Controlled Trial ◽  
Major Depressive

Objective: Conventional antidepressant treatments result in symptom remission in 30% of those treated for major depressive disorder, raising the need for effective adjunctive therapies. Inflammation has an established role in the pathophysiology of major depressive disorder, and minocycline has been shown to modify the immune-inflammatory processes and also reduce oxidative stress and promote neuronal growth. This double-blind, randomised, placebo-controlled trial examined adjunctive minocycline (200 mg/day, in addition to treatment as usual) for major depressive disorder. This double-blind, randomised, placebo-controlled trial investigated 200 mg/day adjunctive minocycline (in addition to treatment as usual) for major depressive disorder. Methods: A total of 71 adults with major depressive disorder ( Diagnostic and Statistical Manual of Mental Disorders–Fourth Edition) were randomised to this 12-week trial. Outcome measures included the Montgomery–Asberg Depression Rating Scale (primary outcome), Clinical Global Impression–Improvement and Clinical Global Impression–Severity, Hamilton Anxiety Rating Scale, Quality of Life Enjoyment and Satisfaction Questionnaire, Social and Occupational Functioning Scale and the Range of Impaired Functioning Tool. The study was registered on the Australian and New Zealand Clinical Trials Register: www.anzctr.org.au , #ACTRN12612000283875. Results: Based on mixed-methods repeated measures analysis of variance at week 12, there was no significant difference in Montgomery–Asberg Depression Rating Scale scores between groups. However, there were significant differences, favouring the minocycline group at week 12 for Clinical Global Impression–Improvement score – effect size (95% confidence interval) = −0.62 [−1.8, −0.3], p = 0.02; Quality of Life Enjoyment and Satisfaction Questionnaire score – effect size (confidence interval) = −0.12 [0.0, 0.2], p < 0.001; and Social and Occupational Functioning Scale and the Range of Impaired Functioning Tool score – 0.79 [−4.5, −1.4], p < 0.001. These effects remained at follow-up (week 16), and Patient Global Impression also became significant, effect size (confidence interval) = 0.57 [−1.7, −0.4], p = 0.017. Conclusion: While the primary outcome was not significant, the improvements in other comprehensive clinical measures suggest that minocycline may be a useful adjunct to improve global experience, functioning and quality of life in people with major depressive disorder. Further studies are warranted to confirm the potential of this accessible agent to optimise treatment outcomes.

scholarly journals Efficacy of brief dynamic interpersonal therapy in patients with major depressive disorder: a prospective, multicenter randomized controlled trial protocol

2020 ◽  
Author(s):  
Lanlan Wang ◽  
Qian Wang ◽  
Wenhui Jiang ◽  
Jianfeng Luo ◽  
Jun Tong ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Treatment Guidelines ◽  
Controlled Trial ◽  
Treatment Phase ◽  
Major Depressive ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Abstract Background: In China, psychodynamic psychotherapies are widely used as a treatment for depression. However, very few efficacy studies of psychodynamic therapies have been conducted with the Chinese population. This paper describes a study protocol of a multicenter randomized controlled trial of Dynamic Interpersonal Psychotherapy (DIT), a brief manualized depression-focused intervention, in Chinese adults with major depressive disorder (MDD). Methods: Recruitmemt is planned in five hospitals. 240 patients with MDD will be randomly allocated on a 1:1:1 basis to either medication plus DIT, medication plus an active control psychotherapy, or medication alone. Patients will be assessed at baseline and at weeks 2, 4, 8, 12, 16 during the acute treatment phase, and 1, 3, 6 and 12 months posttreatment. The primary outcome is change from baseline in the 17-item Hamilton Depression Rating Scale, administered by independent raters who are blind to treatment allocation. The Hamilton Anxiety Rating Scale, Patient Health Questionnaire-9, Generalized Anxiety Disorder 7-item scale, response, remission and relapse rates, self-assessment of overall efficacy and satisfaction of patients, and side effect profiles are secondary measures. Discussion: This will be the first multicentered RCT in China to assess the efficacy of a brief psychodynamic intervention for MDD. The study has the potential to inform clinical treatment guidelines for the treatment of depression in China. Trial registration: ChiCTR，ChiCTR1800016970， Registered on July 5th 2018. Retrospectively registered, http://www.chictr.org.cn/showprojen.aspx?proj=28786.

scholarly journals Portable light therapy in the treatment of unipolar non-seasonal major depressive disorder: study protocol for the LUMIDEP randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e049331
Author(s):  
Eve Cosker ◽  
Marie Moulard ◽  
Samuel Schmitt ◽  
Karine Angioi-Duprez ◽  
Cédric Baumann ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Randomised Controlled Trial ◽  
Depressive Disorder ◽  
Sleep Quality ◽  
Usual Care ◽  
Rating Scale ◽  
Controlled Trial ◽  
Light Therapy ◽  
Major Depressive ◽  
Randomised Controlled

IntroductionMajor depressive disorder (MDD) affects more than 264 million people worldwide and is associated with an impaired quality of life as well as a higher risk of mortality. Current routine treatments demonstrate limited effectiveness. Light therapy (LT) on its own or in combination with antidepressant treatments could be an effective treatment, but the use of conventional LT devices use is restrictive. Portable LT devices allow patients to continue with their day-to-day activities and therefore encourage better treatment compliance. They have not been evaluated in MDD.Methods and analysisThe study is a single-centre, double-blind, randomised controlled trial assessing the efficacy of LT delivered via a portable device in addition to usual care (medical care and drug treatment) for inpatients and outpatients with unipolar non-seasonal MDD. Over the course of 8 weeks, patients use the device daily for 30 min at medium intensity as soon as possible after waking up and preferably between 07:00 and 09:00. All patients continue their usual care with their referring physician. N=50 patients with MDD are included. The primary outcome measure is depressive symptom severity assessed using the Montgomery-Åsberg Depression Rating Scale between baseline and the eighth week. Secondary outcome measures are sleep quality assessed using the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale and anxiety level assessed on the Hamilton Anxiety Rating Scale, between baseline and week 8. Further parameters relating to cognitive function are measured at baseline and after the intervention. An ancillary study aims to evaluate the impact of MDD on the retina and to follow its progression. Main limitations include risk of discontinuation or non-adherence and bias in patient selection.Ethics and disseminationThe study protocol was approved by Ile de France X’s Ethics Committee (protocol number 34–2018). Findings will be published in peer-reviewed journals.Trial registration numberNCT03685942.

Vortioxetine versus citalopram in treating major depressive disorder (MDD)

2017 ◽  
Vol 41 (S1) ◽  
pp. S540-S541
Author(s):  
A. Rossi ◽  
E. Di Tullio ◽  
P. Prosperini ◽  
A. Feggi ◽  
C. Gramaglia ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Adverse Events ◽  
Depressive Disorder ◽  
Cognitive Performance ◽  
Cognitive Dysfunction ◽  
Rating Scale ◽  
Verbal Learning ◽  
Social Impairment ◽  
Efficacy And Safety ◽  
Major Depressive

IntroductionCitalopram is a widely used antidepressant (AD), indicated for the treatment of Major Depressive Disorder (MDD), with a high and Selective Serotonin Reuptake Inhibitory action (SSRI), good efficacy and safety profile. Vortioxetine is a novel multimodal antidepressant compound, with a mixed action on Serotonin (both 5-HT agonism and antagonism). Its clinical efficacy has been established in several short and long term trials; furthermore it proved effective at mitigating cognitive dysfunction, which is addressed to as one of the main causes of social impairment in MMD patients.ObjectivesTo evaluate the relative efficacy and safety of Vortioxetine versus Citalopram, in patients suffering from MDD.AimsTo assess whether Vortioxetine effectiveness and tolerability are comparable to those observed for previous antidepressants.MethodsThe main outcomes were efficacy (variance from baseline to 1 month) in the Montgomery-Åsberg Depression Rating Scale (MADRS) and Hamilton Rating Scale for Depression (HAM-D) and tolerability (adverse events). Changes in cognitive performance were assessed using the following specifics tools: Digit symbol substitution test (DSST), Trail Making Test A (TMT-A) and Hopkins Verbal Learning Test-Revised (HVLT-R).ResultsData collection is ongoing. According to Literature we expect to find a significant number of MDD patients on Vortioxetine to achieve a reduction in depressive symptoms from baseline, to report poor adverse events and to increase their cognitive performance.ConclusionAs shown by recent literature, Vortioxetine might be an effective option in treating MMD with particular focus on cognitive dysfunction.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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