scholarly journals Is MDD the right target for early-stage psychedelic-assisted therapy trials?

2021 ◽  
Author(s):  
Benjamin R. Lewis ◽  
Kevin Byrne
Keyword(s):  
Rating Scales ◽  
Early Stage ◽  
Controlled Trial ◽  
Well Being ◽  
Imperial College ◽  
Double Blind ◽  
Fda Approval ◽  
Illness Category ◽  
The Right

Abstract The recently published Imperial College study of a Phase II, double-blind, randomized, controlled trial comparing psilocybin-assisted therapy to a six-week titration of escitalopram for Major Depressive Disorder (MDD) should raise concerns for this illness category as a target of early psychedelic research given a goal of FDA approval. There are three reasons why MDD is the wrong target at this stage of research development. Firstly, the psychiatric category of MDD is heterogeneous, vaguely-defined, and overdiagnosed in a way that will problematize finding a reliable signal with psychedelic interventions (or any intervention), particularly within non-severe cases. Secondly, current rating scales for MDD (QIDS used in the Imperial College trial, but also HAM-D) are limited in approximating the kinds of things we ultimately care most about with depressive states, namely functional status, quality of life, and well-being: measures that seem more salient for psychedelic interventions and which are not adequately captured by these rating scales used in a majority of clinical trials. And thirdly, there are inherent conflicts between psychiatric conceptualizations of MDD (and its symptom amelioration) and the kinds of perspectives on one’s suffering often occasioned by psychedelic experiences themselves: while these kinds of psychedelic-catalyzed openings may lead to a form of acceptance or equanimity with regards to one’s life circumstances this could be in many ways orthogonal to reductions in HAM-D scores. We argue that for these reasons MDD is a non-ideal target at this stage of the science and propose alternative directions.

The effect of melatonin on appetite and other symptoms in patients with advanced cancer and cachexia: A double-blind placebo-controlled trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9062-9062
Author(s):  
Egidio Del Fabbro ◽  
Rony Dev ◽  
David Hui ◽  
J. Lynn Palmer ◽  
Eduardo Bruera
Keyword(s):  
Quality Of Life ◽  
Weight Loss ◽  
Advanced Cancer ◽  
Interim Analysis ◽  
Controlled Trial ◽  
Well Being ◽  
Test Statistic ◽  
Double Blind ◽  
Edmonton Symptom Assessment Scale

9062 Background: Patients with advanced cancer experience anorexia and weight loss which impairs their quality of life. Prior studies suggest melatonin, a frequently used integrative medicine may attenuate weight loss, anorexia, fatigue, and depression. These studies were limited by a lack of blinding and absence of placebo controls. The primary objective of this study was to compare melatonin to placebo for appetite in patients with cachexia. Methods: A randomized, double-blind, 28 day trial of melatonin 20mg vs. placebo in patients with advanced lung or gastrointestinal cancer, appetite scores >3 on a 0 to 10 scale (10 = worst appetite) and a history of weight loss ≥ 5% within 6 months. Patients unable to maintain oral intake, thyroid or adrenal dysfunction, or with a karnofsky <40 were excluded from the study. The assessments included weight, symptom severity by Edmonton Symptom Assessment Scale (ESAS) and quality of life by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT).Differences between groups from baseline to day 28 were analyzed using one-sided two sample t tests (appetite, pain and well-being) or Wilcoxon two-sample tests for the other variables. Interim analysis at half point had a Lan-DeMets monitoring boundary with an O’Brien-Fleming stopping rule. The decision boundaries for the interim test was to accept the null hypothesis of no treatment difference (futility) if the test statistic Z < 0.39 (p ≥ 0.348). Results: After interim analysis of 48 patients, the study was closed by the Data Safety Monitoring Board for futility. There were no significant differences between groups in appetite (p=0.78), weight (p= 0.17), FAACT score (p=0.95), insomnia (p=0.62) or other symptoms measured by the ESAS from baseline to day 28.No significant toxicities were observed. Conclusions: In cachectic patients with advanced cancer, 20mg oral Melatonin at night does not improve appetite, weight or quality of life compared to placebo.

scholarly journals IDEA intervention to prevent depressive symptoms and promote well-being in early-stage dementia: protocol for a randomised controlled feasibility study

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e021074 ◽  
Author(s):  
Remco Tuijt ◽  
Gill Livingston ◽  
Rebecca L Gould ◽  
Rebecca Jones ◽  
Elisabet Sole Verdaguer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Depressive Symptoms ◽  
Early Stage ◽  
Controlled Trial ◽  
Well Being ◽  
Psychological Interventions ◽  
Mild Dementia ◽  
People With Dementia ◽  
Randomised Controlled

ObjectiveDepressive symptoms are common among people with dementia, impacting quality of life and cognitive and functional decline. Currently, little is known about the acceptability and feasibility of psychological interventions for people with mild dementia, with recent reviews identifying the need for further evidence. Developing and evaluating psychological interventions to prevent and treat these symptoms is, therefore, an important clinical and research priority. This protocol describes a study testing the acceptability and feasibility of a manual-based behavioural activation (BA) intervention for preventing and treating depressive symptoms in people with mild dementia. The aim of this study is to explore the feasibility of conducting a pragmatic multicentre randomised controlled trial of clinical effectiveness of an eight-session intervention. The Intervention to prevent Depressive symptoms and promote well-being in EArly-stage dementia (IDEA) programme supports people with dementia and their family carers in identifying and scheduling enjoyable and meaningful activities.Methods and analysisSixty people who have received a diagnosis of dementia of any type in the last 6 months will be recruited via memory clinics. Further criteria are a Mini-Mental State Examination score of ≥20, and a family carer who can assist with the intervention. Consenting participants will be randomised in a ratio of 2:1 to BA or to treatment as usual. Analyses will estimate parameters such as rates of recruitment, retention and number of sessions completed. Questionnaires measuring depressive symptoms and quality of life for both the person with dementia and their carer will be completed at baseline, 3 and 6 months. Qualitative interviews will explore acceptability of the intervention, study procedures and experiences of the sessions.Ethics and disseminationThis study received a favourable ethical opinion from the London Camberwell St Giles Research Ethics Committee (16/LO/0540). We will disseminate findings at key conferences, the Alzheimer’s Society and University College London websites and local stakeholder events.Trial registration numberISRCTN75503960; Pre-results.

Randomised controlled trial of escitalopram for cervical dystonia with dystonic jerks/tremor

2018 ◽  
Vol 89 (6) ◽  
pp. 579-585 ◽  
Author(s):  
Evelien Zoons ◽  
Jan Booij ◽  
Catherine C S Delnooz ◽  
Joke M Dijk ◽  
Yasmine E M Dreissen ◽  
...  
Keyword(s):  
Adverse Events ◽  
Cervical Dystonia ◽  
Rating Scales ◽  
Psychiatric Symptoms ◽  
Controlled Trial ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Registration Number ◽  
Randomised Controlled

ObjectiveTrials for additional or alternative treatments for cervical dystonia (CD) are scarce since the introduction of botulinum neurotoxin (BoNT). We performed the first trial to investigate whether dystonic jerks/tremor in patients with CD respond to the selective serotonin reuptake inhibitor (SSRI) escitalopram.MethodsIn a randomised, double-blind, crossover trial, patients with CD received escitalopram and placebo for 6 weeks. Treatment with BoNT was continued, and scores on rating scales regarding dystonia, psychiatric symptoms and quality of life (QoL) were compared. Primary endpoint was the proportion of patients that improved at least one point on the Clinical Global Impression Scale for jerks/tremor scored by independent physicians with experience in movement disorders.ResultsFifty-threepatients were included. In the escitalopram period, 14/49 patients (29%) improved on severity of jerks/tremor versus 11/48 patients (23%) in the placebo period (P=0.77). There were no significant differences between baseline and after treatment with escitalopram or placebo on severity of dystonia or jerks/tremor. Psychiatric symptoms and QoL improved significantly in both periods compared with baseline. There were no significant differences between treatment with escitalopram and placebo for dystonia, psychiatric or QoL rating scales. During treatment with escitalopram, patients experienced slightly more adverse events, but no serious adverse events occurred.ConclusionIn this innovative trial, no add-on effect of escitalopram for treatment of CD with jerks was found on motor or psychiatric symptoms. However, we also did not find a reason to withhold patients treatment with SSRIs for depression and anxiety, which are common in dystonia.Trial registration numberNTR2178.

Current measures of distress may not account for what's most important in existential care interventions: Results of the outlook trial

2020 ◽  
Vol 18 (6) ◽  
pp. 648-657
Author(s):  
Karen E. Steinhauser ◽  
Karen M. Stechuchak ◽  
Katherine Ramos ◽  
Joseph Winger ◽  
James A. Tulsky ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Early Stage ◽  
Well Being ◽  
Primary Analysis ◽  
Significant Difference ◽  
Spiritual Well Being ◽  
Screening For Distress ◽  
Secondary Outcomes ◽  
Stage Renal Disease

AbstractObjectiveCompare the efficacy of two interventions addressing emotional and existential well-being in early life-limiting illness.MethodPrimary trial analysis (n = 135) included patients with advanced cancer, congestive heart failure, or end-stage renal disease; Arm 1 received the Outlook intervention, addressing issues of life completion and preparation, and Arm 2 received relaxation meditation (RM). Primary outcomes at five weeks (primary endpoint) and seven weeks (secondary): completion and preparation (QUAL-E); secondary outcomes: anxiety (POMS) quality of life (FACT-G) and spiritual well-being (FACIT-Sp) subscales of faith, meaning, and peace.ResultsAverage age was 62; 56% were post-high school-educated, 54% were married, 52% white, 44% female, and 70% had a cancer diagnosis. At baseline, participants demonstrated low levels of anxiety (<5 on POMS subscale) and depression (<10 on CESD) relative to population norms. Results of the primary analysis revealed no significant differences in mean Preparation by treatment arm at five weeks (14.4 Outlook vs. 14.8 RM; between-group difference −0.4 [95% CI, −1.6, 0.8], p = 0.49) or seven weeks (15.2 vs.15.4; between-group difference −0.2 [95% CI, −1.5, 1.0], p = 0.73). There were also no significant differences in mean Life Completion by treatment arm between five weeks (26.6 Outlook vs. 26.3 RM; between-group difference 0.2 [95% CI, −1.2, 1.7], p = 0.76) or seven weeks (26.5 vs. 27.5; between-group difference −1.0 [95% CI, −2.7, 0.7], p = 0.23). Compared to RM, Outlook participants did not have significant differences over time in the secondary outcomes of overall quality of life, anxiety, depression, FACT-G subscales, and FACIT-Sp subscales.DiscussionIn early-stage life-limiting illness, Outlook did not demonstrate a significant difference in primary or secondary outcomes relative to RM. Results underscore the importance of pre-screening for distress. Qualitatively, Outlook participants were able to express suppressed emotions, place illness context, reflect on adaptations, and strengthen identity. Screening for distress and identifying specified measures of distress, beyond anxiety and depression, is essential in our ability to adequately assess the multi-dimensional mechanisms that decrease existential suffering.

scholarly journals Adjunctive Garcinia mangostana Linn. (Mangosteen) Pericarp for Schizophrenia: A 24-Week Double-blind, Randomized, Placebo Controlled Efficacy Trial: Péricarpe d’appoint Garcinia mangostana Linn (mangoustan) pour la schizophrénie : un essai d’efficacité de 24 semaines, à double insu, randomisé et contrôlé par placebo

2020 ◽  
pp. 070674372098243
Author(s):  
Alyna Turner ◽  
Andrea Baker ◽  
Olivia M. Dean ◽  
Adam J. Walker ◽  
Seetal Dodd ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Schizoaffective Disorder ◽  
Negative Symptoms ◽  
Controlled Trial ◽  
Safety Data ◽  
Rate Of Change ◽  
Adjunctive Treatment ◽  
Garcinia Mangostana ◽  
Double Blind

Objectives: Garcinia mangostana Linn. (“mangosteen”) pericarp contains bioactive compounds that may target biological pathways implicated in schizophrenia. We conducted a double-blind randomized placebo-controlled trial evaluating the efficacy of adjunctive mangosteen pericarp, compared to placebo, in the treatment of schizophrenia. Methods: People diagnosed with schizophrenia or schizoaffective disorder ( Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), recruited across 2 sites (Brisbane and Victoria, Australia), were randomized to receive 24 weeks of adjunctive mangosteen pericarp (1,000 mg/day) or matched placebo. The primary outcome measure was the Positive and Negative Symptom Scale total score. Secondary outcomes included positive and negative symptoms, general psychopathology, clinical global severity and improvement, participant reported overall improvement, depressive symptoms, functioning, quality of life, and safety data at 24 and 28 weeks (4 weeks postdiscontinuation). Data were collected from July 2016 to February 2019. Results: Baseline assessments were conducted on 148 people (mangosteen = 74, placebo = 74); data analyses were conducted on 136 (92%) participants with postbaseline data. The treatment group had significantly higher symptom severity compared to placebo, and both groups significantly improved on all symptom, functioning, and quality of life measures over time. No between-group differences were found for the rate of change between baseline and 24 or 28 weeks. Conclusion: Despite promising preclinical and clinical work, our results do not support mangosteen pericarp extract as an adjunctive treatment for schizophrenia or schizoaffective disorder.

scholarly journals Amelioration of mild and moderate depression through Pranic Healing as adjuvant therapy: randomised double-blind controlled trial

2017 ◽  
Vol 26 (1) ◽  
pp. 82-87 ◽  
Author(s):  
R Rajagopal ◽  
Srikanth N Jois ◽  
Sumanth Mallikarjuna Majgi ◽  
MN Anil Kumar ◽  
HB Shashidhar
Keyword(s):  
Quality Of Life ◽  
Adjuvant Therapy ◽  
Mental Disorder ◽  
Controlled Trial ◽  
Antidepressant Drug ◽  
Double Blind ◽  
Average Decrease ◽  
Moderate Depression ◽  
Post Assessment

Objectives: Depression is a mental disorder, affecting the quality of life. Our study explores the efficacy of Pranic Healing (PH), as an adjuvant therapy in treating depression Methods: In this randomised double-blind controlled trial, 52 participants with a mean age of 34.4 years, with mild to moderate depression were assessed using the Hamilton Depression Rating (HAM-D) scale during the 5-week study. Both Medication + PH (MedPH) and Medication + Mock PH (MedMockPH) groups comprising 26 members received Pranic and mock healing lasting 20 minutes per session respectively once a week for 4 weeks, along with the antidepressant drug. Results: The average decrease in HAM-D score in MedPH was median 11 (Interquartile Range (IQR) 7–12) and was significantly higher compared with the MedMockPH group median 6.5 (IQR 3–9). At pre-assessment, both groups had 8 cases of mild and 18 cases of moderate depression. At post-assessment, HAM-D showed that the improvement in depression category was seen in 69.2% of participants in the MedMockPH group and 100% in MedPH group. Conclusions: These results give first the evidence that PH can aid as an adjuvant therapy for depressed people.

scholarly journals Effects of Dehydroepiandrosterone and Atamestane Supplementation on Frailty in Elderly Men

2006 ◽  
Vol 91 (10) ◽  
pp. 3988-3991 ◽  
Author(s):  
Majon Muller ◽  
Annewieke W. van den Beld ◽  
Yvonne T. van der Schouw ◽  
Diederick E. Grobbee ◽  
Steven W. J. Lamberts
Keyword(s):  
Controlled Trial ◽  
Hormone Replacement ◽  
Subjective Quality Of Life ◽  
Double Blind ◽  
Specific Test ◽  
Age Related ◽  
Strength Tests ◽  
Leg Extensor Power ◽  
General Community

Abstract Background: It has been suggested that the age-related decline of androgens in men plays a distinct role in the development of several aspects of frailty. Therefore, hormone replacement might improve the course of frailty by increasing lean body mass and muscle strength, decreasing fat mass, and improving the subjective quality of life. Objective: The objective of the study was to assess whether hormone replacement with dehydroepiandrosterone (DHEA) and/or atamestane might improve the course of frailty. Design: This was a double-blind, randomized, controlled trial. Setting: The study was conducted in the general community. Participants: Participants included 100 nonhospitalized, nondiseased, independently living men, aged 70 yr and over with low scores on strength tests. Seventeen participants did not complete the trial. Intervention: Subjects were randomly assigned to one of four intervention arms: atamestane (100 mg/d) and placebo, DHEA (50 mg/d) and placebo, a combination of atamestane (100 mg/d) and DHEA (50 mg/d), or two placebo tablets for 36 wk. Main Outcome Measures: Physical frailty was measured by means of a specific test battery, including isometric grip strength, leg extensor power, and physical performance. Results: The randomization was successful, and 83 (83%) men completed the intervention. There were no differences between the treatment arms and placebo group in any of the outcome measurements after intervention. Conclusions: The results of this double-blind, randomized trial do not support the hypothesis that hormone replacement with DHEA and/or atamestane might improve the course of frailty.

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