scholarly journals The Developmental and Translational Study on Biomarkers and Clinical Characteristics-based Diagnostic and Therapeutic Identification of Major Depressive Disorder: Study Protocol for a Multicenter Randomized Controlled Trial in China

2020 ◽  
Vol Volume 16 ◽  
pp. 2343-2351
Author(s):  
Xiaohua Liu ◽  
Yun Wang ◽  
Daihui Peng ◽  
Huifeng Zhang ◽  
Yanqun Zheng ◽  
...  
2020 ◽  
Author(s):  
Lanlan Wang ◽  
Qian Wang ◽  
Wenhui Jiang ◽  
Jianfeng Luo ◽  
Jun Tong ◽  
...  

Abstract Background : Dynamic Interpersonal Psychotherapy (DIT) is a brief manualized depression-focused intervention. This paper describes a study protocol of a multi-site, three-arm randomized controlled trial comparing medication plus DIT to medication alone and medication plus an active control psychotherapy in the treatment of major depressive disorder (MDD). Methods : 240 patients with MDD will be randomly allocated on a 1:1:1 basis to the treatment conditions, with 80 patients in each group. Patients will be assessed pre-and post-intervention and at 6- and 12-months follow-up with the 17-item Hamilton Depression Scale (HAMD-17) and Hamilton Anxiety Scale (HAMA-14) administered by blind evaluators, and the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder-7-item scale(GAD-7), side effect reaction scale (TESS), and The Self-Assessment Scale of the Overall Efficacy and Satisfaction of Patients (SASE). The primary outcome is change from baseline in HAMD-17 scores. Secondary outcomes include rates of response, remission and relapse, change from baseline in self-report depression and measures of anxious symptomatology, and subjective satisfaction of patients. Discussion: This will be the first multicentered RCT in China to assess the potential efficacy of psychotherapy for MDD. The study has the potential to inform clinical treatment guidelines for the treatment of MDD in China. Trial registration : ChiCTR,ChiCTR1800016970, Registered on July 5 th 2018 - Retrospectively registered, http://www.chictr.org.cn/showprojen.aspx?proj=28786 . Key words : Depression; Dynamic Interpersonal Therapy; Multicenter randomized controlled trial,


2020 ◽  
Author(s):  
Lanlan Wang ◽  
Qian Wang ◽  
Wenhui Jiang ◽  
Jianfeng Luo ◽  
Jun Tong ◽  
...  

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.


2021 ◽  
Vol 11 (10) ◽  
pp. 1340
Author(s):  
Erika Martínez-Amorós ◽  
Narcís Cardoner ◽  
Verònica Gálvez ◽  
Aida de Arriba-Arnau ◽  
Virginia Soria ◽  
...  

Few systematic evaluations have been performed of the efficacy of electroconvulsive therapy (ECT) as a relapse prevention strategy in major depressive disorder (MDD). This is a single-blind, multicenter, randomized controlled trial to compare the efficacy and tolerability of pharmacotherapy plus maintenance ECT (M-Pharm/ECT) versus pharmacotherapy alone (M-Pharm) in the prevention of MDD relapse. Subjects with MDD who had remitted with bilateral acute ECT (n = 37) were randomly assigned to receive M-Pharm/ECT (n = 19, 14 treatments) or M-Pharm (n = 18) for nine months. The subjects were followed up for 15 months. The main outcome was relapse of depression, defined as a score of 18 or more on the Hamilton Depression Rating Scale. At nine months, 35% of the subjects treated with M-Pharm/ECT relapsed as compared with 61% of the patients treated with M-Pharm. No statistically significant differences between groups were indicated by either Kaplan–Meier or Cox proportional hazards regression analyses. The subjects without psychotic features were at higher risk of relapse. There were no statistically significant differences in the MMSE scores of the two groups at the end of the study. Further studies are needed to better define the indications for M-ECT in order to improve its efficacy as a relapse prevention strategy.


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