Multicentre, double-blind, randomised placebo-controlled clinical trial on the efficacy of methylphenidate on depressive symptoms in advanced cancer patients

Centeno, Carlos; Sanz, Álvaro; Cuervo, Miguel Angel; Ramos, Daniel; Hernansanz, S.; González, Jesús Ramos; Almaraz, Maria Jose; Lama, Marcos; Vara, F; Nabal, María; Pascual, Antonio

doi:10.1136/bmjspcare-2011-000093

Cited by 16 publications

(10 citation statements)

References 23 publications

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“…Over the years, ESAS has been incorporated as an outcome to assess symptom response in multiple observational studies, open-label studies and randomized controlled trials. (92–101) This has facilitated the documentation of the treatment effect on multiple symptoms simultaneously. For example, in double-blind, randomized controlled trial of dexamethasone for cancer-related fatigue, ESAS-dyspnea as one of the secondary outcomes and showed a trend towards improvement with dexamethasone.…”

Section: Present Applicationsmentioning

confidence: 99%

The Edmonton Symptom Assessment System 25 Years Later: Past, Present, and Future Developments

Hui

Bruera

2017

Journal of Pain and Symptom Management

561

428

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Context Routine symptom assessment represents the cornerstone of symptom management. ESAS is one of the first quantitative symptom assessment batteries that allows for simple and rapid documentation of multiple patient-reported symptoms at the same time. Objective To discuss the historical development of ESAS, its current uses in different settings, and future developments. Methods Narrative review Results Since its development in 1991, ESAS has been psychometrically validated and translated into over 20 languages. We will discuss the variations, advantages and limitations with ESAS. From the clinical perspective, ESAS is now commonly used for symptom screening and longitudinal monitoring in patients seen by palliative care, oncology, nephrology, and other disciplines in both inpatient and outpatient settings. From the research perspective, ESAS has offered important insights into the nature of symptom trajectory, symptom clusters and symptom modulators. Furthermore, multiple clinical studies have incorporated ESAS as a study outcome and documented the impact of various interventions on symptom burden. On the horizon, multiple groups are actively investigating further refinements to ESAS, such as incorporating it in electronic health records, employing ESAS as a trigger for palliative care referral, and coupling ESAS with personalized symptom goals to optimize symptom response assessment. Conclusion ESAS has evolved over the past 25 years to become an important symptom assessment instrument in both clinical practice and research. Future efforts are needed to standardize this tool and explore its full potential to support symptom management.

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Section: Present Applicationsmentioning

confidence: 99%

The Edmonton Symptom Assessment System 25 Years Later: Past, Present, and Future Developments

Hui

Bruera

2017

Journal of Pain and Symptom Management

561

428

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“…Patients experience a marked elevation in mood, self-esteem, alertness, focus, cognitive function, and regulation of appetite [ 7 , 13 , 18 , 19 , 23 , 53 , 158 ]. A study of patients taking 10 mg methylphenidate twice a day, limited to 80 mg per day or adequate response, found that 23 out of 30 (77%) end-stage cancer patients treated had moderate to marked improvement in depressive symptoms ([ 167 ], also see [ 166 ]). Only two patients withdrew due to intractable side-effects ([ 167 ], also see [ 53 ]).…”

Section: Resultsmentioning

confidence: 99%

“…Methylphenidate is also associated with side-effects such as headaches, anxiety, hypertension, and cardiac arrhythmias [ 23 ]. Additionally, modofinil has sympathomimetic effects and, thus, is a good choice for older end-stage cancer patients [ 7 , 13 , 114 , 166 , 168 ].…”

Section: Resultsmentioning

confidence: 99%

A research study review of effectiveness of treatments for psychiatric conditions common to end-stage cancer patients: needs assessment for future research and an impassioned plea

Johnson

2018

BMC Psychiatry

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BackgroundRates of psychiatric conditions common to end-stage cancer patients (delirium, depression, anxiety disorders) remain unchanged. However, patient numbers have increased as the population has aged; indeed, cancer is a chief cause of mortality and morbidity in older populations. Effectiveness of psychiatric interventions and research to evaluate, inform, and improve interventions is critical to these patients’ care. This article’s intent is to report results from a recent review study on the effectiveness of interventions for psychiatric conditions common to end-stage cancer patients; the review study assessed the state of research regarding treatment effectiveness. Unlike previous review studies, this one included non-traditional/alternative therapies and spirituality interventions that have undergone scientific inquiry.MethodsA five-phase systematic strategy and a theoretic grounded iterative methodology were used to identify studies for inclusion and to craft an integrated, synthesized, comprehensive, and reasonably current end-product.ResultsPsychiatric medication therapies undoubtedly are the most powerful treatments. Among them, the most effective (i.e., “best practices benchmarks”) are: (1) for delirium, typical antipsychotics—though there is no difference between typical vs. atypical and other antipsychotics, except for different side-effect profiles, (2) for depression, if patient life expectancy is ≥4–6 weeks, then a selective serotonin reuptake inhibitor (SSRI), and if < 3 weeks, then psychostimulants or ketamine, and these generally are useful anytime in the cancer disease course, and (3) for anxiety disorders, bio-diazepams (BDZs) are most used and most effective. A universal consensus suggests that psychosocial (i.e., talk) therapy and spirituality interventions fortify the therapeutic alliance and psychiatric medication protocols. However, trial studies have had mixed results regarding effectiveness in reducing psychiatric symptoms, even for touted psychotherapies.ConclusionsThis study’s findings prompted a testable linear conceptual model of co-factors and their importance for providing effective psychiatric care for end-stage cancer patients. The complicated and tricky part is negotiating patients’ diagnoses while articulating internal intricacies within and between each of the model’s co-factors. There is a relative absence of scientifically derived information and need for more large-scale, diverse scientific inquiry. Thus, this article is an impassioned plea for accelerated study and better care for end-stage cancer patients’ psychiatric conditions.

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“…Another study compared methylphenidate with placebo in 69 patients with advanced cancer and depressive symptoms (although not necessarily clinical depression). Methylphenidate showed a positive trend in the incidence of response that did not reach statistical significance . Some randomized trials of treatment of fatigue with methylphenidate in patients with cancer included depression measures, although elevated thresholds for depressive severity were not required for inclusion.…”

Section: Discussionmentioning

confidence: 99%

“…Psychostimulants may also decrease opioid sedation and improve cognitive function in patients with cancer . Among two small clinical trials of methylphenidate for treatment of depression in patients with advanced cancer, one showed benefit even though only 44% of participants completed the study; another showed a positive trend …”

Section: Introductionmentioning

confidence: 99%

Randomized, double‐blind, placebo‐controlled study of methylphenidate for the treatment of depression in SSRI‐treated cancer patients receiving palliative care

et al. 2016

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Objective To determine the effectiveness of methylphenidate for depression treatment in advanced cancer patients. Methods An 18-day randomized, double-blind, placebo-controlled clinical trial of methylphenidate for treatment of depression in selective serotonin reuptake inhibitor (SSRI)-treated patients with advanced cancer in hospice or receiving palliative care. The primary outcome was depression remission, defined as a ≥50% reduction in score on the Montgomery-Asberg Depression Rating Scale. Results Among 47 enrolled participants, 35 were randomized. At study day 18, 85% of the methylphenidate and 60% of the placebo group were in depression remission (p = 0.22). Mean time to depression remission was 10.3 days [standard error (SE) 1.8] in the methylphenidate and 8.1 (SE 1.3) in the placebo group (p = 0.48). The mean baseline score for the Hospital Anxiety and Depression Scale (HADS) was 10.4 in each group and decreased by 3.6 (SE 1.1) in the methylphenidate and 2.3 (SE 1.2) in the placebo group (p = 0.51) by day 18. Once in remission, 1 methylphenidate and 5 placebo participants relapsed to depression (p=0.18). There was no difference in mortality between the groups during the trial. Trial results were limited by small sample size attributed to difficulties in recruiting terminally ill patients. Conclusions This trial failed to demonstrate that methylphenidate treatment in SSRI-treated patients had a significant effect on depression remission in advanced cancer patients. This study underscores the difficulties in conducting trials for symptom management in patients with shortened life expectancy.

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Multicentre, double-blind, randomised placebo-controlled clinical trial on the efficacy of methylphenidate on depressive symptoms in advanced cancer patients

Abstract: Compared with the placebo, methylphenidate demonstrated a positive trend in the incidence of response for depressive symptoms in advanced cancer patients.

Cited by 16 publications

References 23 publications

The Edmonton Symptom Assessment System 25 Years Later: Past, Present, and Future Developments

The Edmonton Symptom Assessment System 25 Years Later: Past, Present, and Future Developments

A research study review of effectiveness of treatments for psychiatric conditions common to end-stage cancer patients: needs assessment for future research and an impassioned plea

Randomized, double‐blind, placebo‐controlled study of methylphenidate for the treatment of depression in SSRI‐treated cancer patients receiving palliative care

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