scholarly journals Open-Label Placebo for Major Depressive Disorder: A Pilot Randomized Controlled Trial

2012 ◽  
Vol 81 (5) ◽  
pp. 312-314 ◽  
Author(s):  
John M. Kelley ◽  
Ted J. Kaptchuk ◽  
Cristina Cusin ◽  
Samuel Lipkin ◽  
Maurizio Fava
Keyword(s):  
Randomized Controlled Trial ◽  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Controlled Trial ◽  
Open Label ◽  
Major Depressive ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Virtual Reality Behavioral Activation as an Intervention for Major Depressive Disorder: A Feasibility and Pilot Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Margot Paul ◽  
Kim Bullock
Keyword(s):  
Randomized Controlled Trial ◽  
Virtual Reality ◽  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Behavioral Activation ◽  
Controlled Trial ◽  
Treatment Control ◽  
Major Depressive ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

UNSTRUCTURED Context: Major depressive disorder (MDD) is a global crisis with increasing incidence and prevalence. There are many established evidence-based psychotherapies (EBP’s) for depression, but they present with various limitations. Virtual reality (VR) may offer some solutions to these limitations of existing MDD EBP’s. Objective: To examine the feasibility, acceptability, and tolerability of using VR as a method of delivering behavioral activation (BA) for adults diagnosed with MDD during a global pandemic. To explore the degree of clinical efficacy of using VR to engage in BA compared to (1) a BA treatment as usual and (2) a non-treatment control group for individuals diagnosed with MDD. Design, Settings, Participants: We conducted a feasibility trial and a three-arm nonblinded between-subjects pilot randomized controlled trial. This study took place remotely via Zoom telehealth between April 8, 2020 and January 15, 2021. Intervention: This study employed a three week, four-session BA protocol, where the VR BA participants used a VR headset to complete their BA homework. Outcome Measures: The primary outcome was measured by dropout rates, serious adverse events, completion of homework, an adapted telepresence scale, a simulator sickness questionnaire, a brief agitation measure, and an adapted technology acceptance model. The secondary outcome was measured by the Patient Health Questionnaire-9 (PHQ-9). Results: Of the 35 participants assessed for eligibility, 13 were randomized to VR BA (n=5), BA TAU (n=4), or a non-treatment control (n=4). The mean age of the 13 participants (5 male, 7 female, 1 non-binary/third gender) was 35.4 (SD = 12.3). This study demonstrated that VR is a feasible, acceptable, and tolerable method of experiencing pleasurable activities in conjunction with a brief BA protocol for individuals diagnosed with MDD. No adverse events were reported. This study also illustrated that VR BA has potential clinical utility in treating symptoms of depression, as the average VR BA participant diagnosis changed from a moderate severity level to mild depression, with a clinically significant average decrease of 5.67 on the PHQ-9. Conclusion: The findings of this study demonstrate that VR BA is a feasible treatment for MDD. This study documented evidence of VR BA’s efficacy and further justification to explore its true effect in an adequately powered RCT. This pilot documented the potential utility that VR could offer patients with MDD, especially those who have difficulty accessing real-world pleasant activities. VR may also be a viable alternative to psychiatric medications for MDD, given its high tolerability and lack of side effects. Additionally, for those having difficulty accessing care, VR BA could be adapted as a first step to help people improve mood and increase motivation while waiting to connect with a healthcare professional for other EBP’s. INTERNATIONAL REGISTERED REPORT RR2-10.2196/24331

Comparing Effectiveness of a Combined Herbal Drug Based on Echium Amoenum with Citalopram in the Treatment of Major Depressive Disorder

2019 ◽  
Vol 16 (2) ◽  
pp. 232-238 ◽  
Author(s):  
Majid Anushiravani ◽  
Ali A. Manteghi ◽  
Ali Taghipur ◽  
Mahdi Eslami
Keyword(s):  
Randomized Controlled Trial ◽  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Controlled Trial ◽  
Herbal Drug ◽  
Medical Sciences ◽  
Major Depressive ◽  
Dsm 5 ◽  
Randomized Controlled ◽  
Echium Amoenum

Background: According to new studies, only 60% of depressed patients respond to pharmaceutical treatment while suffering from their side effects. Natural products as adjuvant or alternative therapies should be examined to find safer and more effective ways to cope with depression. Objective: To find out the potential benefits of a combined herbal drug based on Echium amoenum compared with citalopram in the treatment of Major Depressive Disorder. Design and Setting: In psychiatry clinics of Mashhad University of Medical Sciences, 50 patients who met the criteria for Major Depressive Disorder based on DSM-5 were studied in a parallel randomized controlled trial. Design and Setting: In psychiatry clinics of Mashhad University of Medical Sciences, 50 patients who met the criteria for Major Depressive Disorder based on DSM-5 were studied in a parallel randomized controlled trial. Intervention: Subjects were randomly assigned to receive Echium amoenum compound syrup (EACS) or citalopram tablet for 8 weeks. Outcome Measures: The efficacy of treatments and recurrence of disease were surveyed and compared according to Hamilton depression rating scale at weeks 0, 4, 8, 12. Results: Patients in both groups of citalopram and EACS showed remarkable reduction in scores of Hamilton questionnaire. At the eighth week of treatment, the mean scores in EACS group were significantly lower than citalopram group (p-value = 0.03). 52% of patients suffered from various complications in citalopram group while just 12% of patients in EACS group reported few complications. Conclusion: Clinical efficacy of this herbal drug was significantly higher than citalopram, and complications were also less and lower in EACS group. Further studies with larger groups and para-clinical assessments such as serologic tests and QEEG would improve our understanding of the impacts and mechanisms of EACS.

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