scholarly journals Clinical research challenges posed by difficult-to-treat depression

2022 ◽  
pp. 1-14
Author(s):  
A. John Rush ◽  
Harold A. Sackeim ◽  
Charles R. Conway ◽  
Mark T. Bunker ◽  
Steven D. Hollon ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Clinical Trial Design ◽  
Assessment Tools ◽  
Control Group ◽  
Therapeutic Effects ◽  
Sustained Remission ◽  
Short Term ◽  
Trial Methodology ◽  
Outcome Metrics

Abstract Approximately one-third of individuals in a major depressive episode will not achieve sustained remission despite multiple, well-delivered treatments. These patients experience prolonged suffering and disproportionately utilize mental and general health care resources. The recently proposed clinical heuristic of ‘difficult-to-treat depression’ (DTD) aims to broaden our understanding and focus attention on the identification, clinical management, treatment selection, and outcomes of such individuals. Clinical trial methodologies developed to detect short-term therapeutic effects in treatment-responsive populations may not be appropriate in DTD. This report reviews three essential challenges for clinical intervention research in DTD: (1) how to define and subtype this heterogeneous group of patients; (2) how, when, and by what methods to select, acquire, compile, and interpret clinically meaningful outcome metrics; and (3) how to choose among alternative clinical trial design options to promote causal inference and generalizability. The boundaries of DTD are uncertain, and an evidence-based taxonomy and reliable assessment tools are preconditions for clinical research and subtyping. Traditional outcome metrics in treatment-responsive depression may not apply to DTD, as they largely reflect the only short-term symptomatic change and do not incorporate durability of benefit, side effect burden, or sustained impact on quality of life or daily function. The trial methodology will also require modification as trials will likely be of longer duration to examine the sustained impact, raising complex issues regarding control group selection, blinding and its integrity, and concomitant treatments.

scholarly journals Psilocybin for depression: Considerations for clinical trial design

2019 ◽  
Vol 3 (3) ◽  
pp. 269-279
Author(s):  
Kelley C. O’Donnell ◽  
Sarah E. Mennenga ◽  
Michael P. Bogenschutz
Keyword(s):  
Clinical Trial ◽  
Trial Design ◽  
Depressive Symptomatology ◽  
Specific Effect ◽  
Clinical Trial Design ◽  
Depressive Illness ◽  
Trial Methodology ◽  
Trial Duration ◽  
Clinical Trial Methodology ◽  
Psychedelic Drugs

Background and aims Given the enormous global burden of depressive illness, there is an urgent need to develop novel and more effective treatments for major depressive disorder (MDD). Recent findings have suggested that psychedelic drugs may have a role in the treatment of depressive symptoms, and a number of groups are in the process of developing protocols to study this question systematically. Given the subjective quality of both the psychedelic experience and depressive symptomatology, great care must be taken when designing a protocol to study the clinical efficacy of psychedelic drugs. This study will discuss many factors to consider when designing a clinical trial of psilocybin for MDD. Methods We provide a thorough review of pertinent research into antidepressant clinical trial methodology and review practical considerations that are relevant to the study of psychedelic-assisted treatment for depression. Results We discuss participant selection (including diagnostic accuracy, exclusion criteria, characteristics of the depressive episode, and the use of concurrent medications), study interventions (including dosing regimens, placebo selection, non-pharmacological components of treatment, and the importance of blinding), trial duration, outcome measures, and safety considerations. Conclusions Careful and transparent study design and data analysis will maximize the likelihood of generating meaningful, reproducible results, and identifying a treatment-specific effect. Meeting the highest standards for contemporary trial design may also broaden the acceptance of psychedelic research in the scientific community at large.

scholarly journals Effect of Mindfulness Sessions on Chronic Fatigue Syndrome and Job Satisfaction of Nurses: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Nasrin Bonakdari ◽  
Nadereh Mohammadi ◽  
Mohammad Reza Taghvizadeh Yazdi ◽  
Reza Norouzadeh ◽  
Mohammad Abbasinia ◽  
...  
Keyword(s):  
Job Satisfaction ◽  
Clinical Trial ◽  
Chronic Fatigue Syndrome ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Clinical Trial Design ◽  
Well Being ◽  
Chronic Fatigue ◽  
Control Group ◽  
Fatigue Syndrome

Abstract Background: Nursing is considered a stressful profession, so nurses are at higher risk of physical and mental illness. Mindfulness is an important concept for nursing with practical implications for nurse well-being, development, and quality nursing care sustainability.Objectives: This study identified mindfulness sessions' effect on nurses' chronic fatigue syndrome(CFS) and job satisfaction )JS.(Methods: A randomized clinical trial design was conducted on 80 nurses to intervention and control groups. The intervention in the intervention group was eight mindfulness sessions training, and the control group had no intervention. Nurses' CFS and JS were assessed using the Minnesota Satisfaction Questionnaire and The Multidimensional Fatigue Inventory.Results: After implementing a mindfulness-based stress reduction program, the intervention group nurses reported lower CFS and higher JS than the control group(p<0.005). Conclusion: The findings of this study indicate the effectiveness of mindfulness programs on improving nurses' chronic fatigue and JS. Since CFS and job dissatisfaction are two disturbing elements for nurses' optimal performance in professional and personal life, this study can recommend the implementation of mindfulness exercises as a routine, operational and uncomplicated program in nurses.

scholarly journals Comparison of the Effectiveness of Chelleh Daghi Herbal Ointment and Piroxicam Gel on Ankle Sprains

2020 ◽  
Vol 23 (4) ◽  
pp. 450-461
Author(s):  
Alireza Amani ◽  
◽  
Ali Kamali ◽  
Bahman Sadeghi ◽  
Ali Reza Sistani ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Statistical Tests ◽  
Joint Inflammation ◽  
Ankle Injuries ◽  
Control Group ◽  
Case Group ◽  
Therapeutic Effects ◽  
Ankle Sprains ◽  
Significant Difference ◽  
The Mean

Background and Aim: Ankle injuries are among the most common musculoskeletal injuries in sports, accounting for 10% to 15% of all injuries. Since controlling pain and inflammation in ankle sprains is one of the main goals of treatment, we decided to compare the therapeutic effects of Cheleh daghi Herbal ointment with a common therapeutic gel such as piroxicam. Methods & Materials: This study was performed as a double-blinded clinical trial for 6 months from January 2019 to August 2019. After referral, all patients completed the consent form, and the patientchr('39')s details and study variables were recorded by the evaluator in the research form. To measure joint inflammation, we measured the ankle with a meter tape in the ankle area (cm) and recorded. A goniometer was also used to measure the degree of ankle movements. The symptoms of ankle ecchymosis were also checked by physical examination and observation and recorded in the checklist. Statistical analysis was performed in SPSS V. 18 using statistical tests (the Mann-Whitney U test, the Chi-square, and the independent t-test). Ethical Considerations: The Research Ethics Committee of Arak University of Medical Sciences approved the study (Code: IR.ARAKMU.REC.1396.55) and registered by the Clinical Trial (Code: IRCT2017071720258N53). Results: The Mean±SD age in the control group was 34.2±8.6 years, and in the case group was 35.4±8.9 years. There was no statistically significant difference according to the Mann-Whitney U test (P<0.05). Also, the Mean±SD height in the control group was 1.7±0.12 m and in the case group was 1.72±0.11 m. The results also showed a statistically significant difference between the two groups studied before and after the intervention regarding the mean indicators of pain, swelling, and inflammation around the joints (P<0.05). Conclusion: The results of our study showed that Cheleh daghi Herbal ointment for 3 weeks could be more effective in reducing local pain and inflammation than piroxicam gel treatment.

scholarly journals The Effect of Artichoke Leaf Extract on Alanine Aminotransferase and Aspartate Aminotransferase in the Patients with Nonalcoholic Steatohepatitis

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Vajiheh Rangboo ◽  
Mostafa Noroozi ◽  
Roza Zavoshy ◽  
Seyed Amirmansoor Rezadoost ◽  
Asghar Mohammadpoorasl
Keyword(s):  
Clinical Trial ◽  
Nonalcoholic Steatohepatitis ◽  
Liver Enzymes ◽  
Intervention Group ◽  
Control Group ◽  
Therapeutic Effects ◽  
Hypolipidemic Effect ◽  
Linear Regression Models ◽  
Double Blind ◽  
Cynara Scolymus

Background. Based on recent basic and clinical investigations, the extract of artichoke (Cynara scolymus) leaf has been revealed to be used for hepatoprotective and cholesterol reducing purposes. We aimed to assess the therapeutic effects of artichoke on biochemical and liver biomarkers in patients with nonalcoholic steatohepatitis (NASH).Methods. In a randomized double blind clinical trial, 60 consecutive patients suffering NASH were randomly assigned to receiveCynara scolymusextract (as 6 tablets per day consisting of 2700 mg extract of the herb) as the intervention group or placebo as the control group for two months.Results. Comparing changes in study markers following interventions showed improvement in liver enzymes. The levels of triglycerides and cholesterol were significantly reduced in the group treated withCynara scolymuswhen compared to placebo group. To compare the role ofCynara scolymususe with placebo in changes in study parameters, multivariate linear regression models were employed indicating higher improvement in liver enzymes and also lipid profile particularly triglycerides and total cholesterol following administration ofCynara scolymusin comparison with placebo use.Conclusion. This study sheds light on the potential hepatoprotective activity and hypolipidemic effect ofCynara scolymusin management of NASH. This clinical trial is registered in the IRCT, Iranian Registry of Clinical Trials, by numberIRCT2014070218321N1.

scholarly journals Obstacles and Considerations Related to Clinical Trial Research During the COVID-19 Pandemic

2020 ◽  
Vol 7 ◽  
Author(s):  
Hasan Hashem ◽  
Mohammad Abufaraj ◽  
Abdelghani Tbakhi ◽  
Iyad Sultan
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Ethical Issues ◽  
Clinical Trial Design ◽  
Cost Effective ◽  
Clinical Trial Research ◽  
External Monitoring ◽  
Treatment And Prevention ◽  
Clinical Research Trials

The response to the COVID-19 pandemic from the research and science community has been vigorous, with information being released faster than that of any other event in human history. Articles related to the virus were being rapidly published by January 2020. A small fraction of these publications comprised reports of prospective clinical trials (0.25%), and many of these trials have imparted conflicting conclusions, leading to confusion among the public and the scientific community. Additionally, the pandemic has raised many serious scientific and ethical concerns related to clinical research. In this review, we divided the conduct of clinical research trials into three steps and critically reviewed each step, along with the challenges and obstacles arising amid the ongoing crisis. The clinical research steps we reviewed include (1) clinical trial design factors such as social and scientific value, feasibility, single vs. multicenter trials, randomization, control groups, endpoints, off-label and compassionate use of medications, data analysis, and verifying the integrity of data; (2) ethical issues such as committee approvals, efficiency, virtual visits and remote monitoring, informed consent, shipping investigational products, and external monitoring and audits; and (3) publication and sharing of preprints, press releases, social media, and misinformation. The COVID-19 pandemic is adversely affecting existing clinical trials for other ailments and diseases, including cancer, with most trials being delayed or deferred. Although urgency is needed to communicate effective treatment and prevention strategies for COVID-19, research efforts should maintain the same high-quality core ethical principles that governed human subject research before the pandemic. Despite the catastrophic devastation caused by the pandemic, the adoption of more flexible, cost-effective methods of conducting clinical trials (without compromising ethical conduct, safety, or data integrity, while maintaining research efficiency) represents a potential silver lining. Streamlining clinical research will help to congruently address other important health issues, despite the ongoing COVID-19 crisis.

scholarly journals Effects of perioperative ERAS pathway management VS traditional management on clinical outcomes in laparoscopic-assisted radical resection of distal gastric cancer The GISSG18-01 Randomized Clinical Trial

2020 ◽  
Author(s):  
Yulong Tian ◽  
Shougen Cao ◽  
Leping Li ◽  
Qingsi He ◽  
Lijian Xia ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Cancer Patients ◽  
Radical Resection ◽  
Control Group ◽  
Short Term ◽  
Traditional Management ◽  
Gastric Cancer Patients ◽  
Laparoscopic Assisted ◽  
Experimental Group

Abstract Background: As well known, the incidence of gastric cancer in East Asian countries is much higher than the international average. Therefore, improving the prognosis of patients and establishing effective clinical pathways are important topics for the prevention and treatment of gastric cancer. At present, the enhanced recovery after surgery (ERAS) pathway is widely used in the field of gastric surgery. Many RCT studies have proven that the ERAS regimen can not improve the short-term clinical outcomes of gastric cancer patients. However, a prospective study on the effect of the ERAS pathway on the prognosis of gastric cancer patients has not been reported. This trial aims to confirm whether ERAS pathway can improve disease-free survival (DFS) and overall survival (OS) in patients undergoing laparoscopic-assisted radical resection for distal gastric cancer.Methods/design: This study is a prospective, multicenter, randomized controlled trial (RCT). This experiment will include randomly divided groups, the experimental group and the control group, according to a proportion of 1:1. The perioperative period of the experimental group will be managed according to the ERAS pathway, and the control group will be managed according to the traditional management mode. An estimated 400 patients will be enrolled. The main endpoint is to compare the 3-year OS and PFS between the two groups.Discussion: This RCT should demonstrate whether ERAS pathway is superior to traditional treatment on inflammatory indexes, short-term clinical outcome and survival for laparoscopic assisted radical resection of distal gastric cancer.Our data can provide evidence that the ERAS pathway improves survival in patients with gastric cancer.Trial registration: Chinese Clinical Trial Registry, CHiCTR1900022438. Registered on 11 April 2019

scholarly journals Clinical Trial to Analyze the Effect of Oral Intake of Phellinus Linteus(Sanghuang) Extract on Immune Function: A Study Protocol for a Randomized, Double-blind Controlled Trial

2021 ◽  
Author(s):  
Yong Ho Ku ◽  
Hyun Lee ◽  
Hwa Yeon Ryu ◽  
Jae Hui Kang
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Immune Function ◽  
Controlled Trial ◽  
Information Service ◽  
Laboratory Evaluation ◽  
Control Group ◽  
Phellinus Linteus ◽  
Research Information ◽  
Main Trial

Abstract Background: As Korea becomes an aging society, interest in health care has increased. In particular, there is an increasing demand for immune function improvement to prevent infectious diseases. Phellinus linteus (PL) has previously been shown to have immune-enhancing and anticancer effects. We aim to evaluate whether PL mycelium extract, cultured using the PL KCTC0399BP strain, has an increase in immune function using blood test indicators. This clinical trial is designed based on the results of a pilot study as the main trial.Methods: This clinical trial will be a randomized, double-blinded, placebo-controlled trial. Ninety-eight participants will be enrolled and randomly divided into two groups: experimental group (PL 1000 mg) and control group (placebo). Participants will be administered experimental food or placebo for 8 weeks. Blood tests will be performed before food intake and at 8 weeks after the start of the experiment. Laboratory evaluation items are as follows: natural killer cell activity, tumor necrosis factor-α, interferon-γ, interleukin (IL)-1β, IL-2, IL-6, IL-12, immunoglobulin (Ig)G1, IgG2, and IgM. We will mainly use the full analysis set to statistically analyze the effectiveness of treatment.Discussion: This study includes inclusion and exclusion criteria and a well-controlled intervention. This study evaluates the effect of PL extract on immune function and will contribute to knowledge on the value of PL as an immune function health functional food.Clinical research registration: This study has been registered at the Clinical Research Information Service (CRIS) of Korea: CRIS-KCT0005460. Registered , 12 October 2020, https://cris.nih.go.kr/cris/search/search_result_st01_en.jsp?seq=17761&ltype=&rtype=Trial status: This clinical trial is in the recruitment stage. Recruitment began in October 21, 2020 and will be completed in March 2021. This trial was registered at the Clinical Research Information Service of South Korea on October 12, 2020. (CRIS-KCT0005460)

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