scholarly journals Effects and Feasibility of Hyperthermic Baths for Patients with Depressive Disorder: A Randomized Controlled Clinical Pilot Trial

2018 ◽  
Author(s):  
Johannes Naumann ◽  
Catharina Sadaghiani ◽  
Iris Kruza ◽  
Luisa Denkel ◽  
Gunver Kienle ◽  
...  
Keyword(s):  
Depressive Disorder ◽  
Doctoral Students ◽  
Rating Scale ◽  
Water Immersion ◽  
Pilot Trial ◽  
Severe Depression ◽  
Moderate Intensity ◽  
Open Label ◽  
Serious Adverse Events ◽  
Randomized Controlled

AbstractBackgroundEvaluation of efficacy, safety and feasibility of hyperthermic baths (HTB; head-out-of-water-immersion in 40°C), twice a week, compared to a physical exercise program (PEP; moderate intensity aerobic exercises) in moderate to severe depression.MethodSingle-site, open-label randomized controlled 8-week parallel-group pilot study at an university outpatient clinic as part of usual depression care. Medically stable outpatients with depressive disorder (ICD-10: F32/F33) as determined by the 17-item Hamilton Depression Rating Scale (HAM-D) score ≥18 and a score ≥2 on item 1 (Depressed Mood) were randomly assigned to receive either two sessions of HTB or PEP per week (40-45 min) provided by two trained doctoral students. An independent biometric center used computer-generated tables to allocate treatments. Primary outcome measure was the change in HAM-D total score from baseline (T0) to the 2-week time point (T1). Linear regression analyses, adjusted for baseline values, were performed to estimate intervention effects on an intention-to-treat (ITT) principle.Findings45 patients (HTB n = 22; PEP n = 23) were randomized and analyzed according to ITT (mean age = 48.4 years, SD = 11.3, mean HAM-D score = 21.7, SD = 3.2). Baseline-adjusted mean difference was 4.3 points in the HAM-D score in favor of HTB (p<0.001). This improvement was achieved after two weeks. Compliance with the intervention and follow-up was far better in the HTB group (2 vs 13 dropouts). There were no treatment-related serious adverse events. Main limitation: the number of dropouts in the PEP group (13 of 23) was far higher than in other trials investigating exercise in depression (18.1 % dropouts).ConclusionsHTB seems to be a fast-acting, safe and easy accessible method leading to clinically relevant improvement in depressive disorder after two weeks; it is also suitable for persons who have problems performing exercise training.Trial registrationGerman Clinical Trials Register (DRKS) with the registration number DRKS00011013 (registration date 2016-09-19) before onset of the study.

scholarly journals Effects and feasibility of hyperthermic baths in comparison to exercise as add-on treatment to usual care in depression: a randomised, controlled pilot study

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Johannes Naumann ◽  
Iris Kruza ◽  
Luisa Denkel ◽  
Gunver Kienle ◽  
Roman Huber
Keyword(s):  
Pilot Study ◽  
Usual Care ◽  
Rating Scale ◽  
Water Immersion ◽  
Exercise Program ◽  
Moderate Intensity ◽  
Current Therapy ◽  
Open Label ◽  
Serious Adverse Events ◽  
Randomised Controlled

Abstract Background Limitations of current therapy of depression highlight the need for an immediately available, easily implementable add-on treatment option with high acceptance from patients. Hyperthermic baths (HTB) are a form of balneotherapy with head-out-of-water-immersion in a hot pool or tub at 40 °C for 15–20 min. A prior study suggests that HTB added to usual depression care can have antidepressant effects. Method Single-site, open-label randomised controlled 8-week parallel-group pilot study at a university outpatient clinic. 45 medically stable outpatients with moderate depression as determined by the 17-item Hamilton Depression Rating Scale (HAM-D) score ≥ 18 and a score ≥ 2 on item 1 (Depressed Mood) were recruited. They were randomised to twice weekly HTB (n = 22) or a physical exercise program (PEP) of moderate intensity (n = 23). Primary outcome measure was the change in HAM-D total score from baseline (T0) to the 2-week time point (T1). Linear regression analyses, adjusted for baseline values, were performed to estimate intervention effects on an intention-to-treat (ITT) and per-protocol (PP) principle. Results Forty-five patients (HTB n = 22; PEP n = 23) were analyzed according to ITT (mean age = 48.4 years, SD = 11.3, mean HAM-D score = 21.7, SD = 3.2). Baseline-adjusted mean difference after 2 weeks was 4.3 points in the HAM-D score in favor of HTB (p < 0.001). Compliance with the intervention and follow-up was far better in the HTB group (2 vs 13 dropouts). Per protocol analysis only showed superiority of HTB as a trend (p = 0.068). There were no treatment-related serious adverse events. Main limitation: the number of dropouts in the PEP group (13 of 23) was higher than in other trials investigating exercise in depression. Due to the high number of dropouts the effect in the ITT-analysis may be overestimated. Conclusions HTB added to usual care may be a fast-acting, safe and easy accessible method leading to clinically relevant improvement in depression severity after 2 weeks; it is also suitable for persons who have problems performing exercise training. Trial registration German Clinical Trials Register (DRKS) with the registration number DRKS00011013 (registration date 2016-09-19) before onset of the study.

scholarly journals Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD

2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Scott H. Kollins ◽  
Ann Childress ◽  
Andrew C. Heusser ◽  
Jacqueline Lutz
Keyword(s):  
Video Game ◽  
Primary Outcome ◽  
Rating Scale ◽  
Stimulant Medication ◽  
Additional Treatment ◽  
Adhd Medication ◽  
Open Label ◽  
Serious Adverse Events ◽  
Treatment Benefit ◽  
Hyperactivity Disorder

AbstractSTARS-Adjunct was a multicenter, open-label effectiveness study of AKL-T01, an app and video-game-based treatment for inattention, as an adjunct to pharmacotherapy in 8–14-year-old children with attention-deficit/hyperactivity disorder (ADHD) on stimulant medication (n = 130) or not on any ADHD medication (n = 76). Children used AKL-T01 for 4 weeks, followed by a 4-week pause and another 4-week treatment. The primary outcome was change in ADHD-related impairment (Impairment Rating Scale (IRS)) after 4 weeks. Secondary outcomes included changes in IRS, ADHD Rating Scale (ADHD-RS). and Clinical Global Impressions Scale—Improvement (CGI-I) on days 28, 56, and 84. IRS significantly improved in both cohorts (On Stimulants: −0.7, p < 0.001; No Stimulants: −0.5, p < 0.001) after 4 weeks. IRS, ADHD-RS, and CGI-I remained stable during the pause and improved with a second treatment period. The treatment was well-tolerated with no serious adverse events. STARS-Adjunct extends AKL-T01’s body of evidence to a medication-treated pediatric ADHD population, and suggests additional treatment benefit.

scholarly journals Predictors of Suicidal Ideation and Attempt among Patients with Major Depressive Disorder at a Tertiary Care Hospital, Puducherry

2021 ◽  
Vol 12 (01) ◽  
pp. 122-128
Author(s):  
Ralte Lalthankimi ◽  
Padmavathi Nagarajan ◽  
Vikas Menon ◽  
Jeby Jose Olickal
Keyword(s):  
Major Depressive Disorder ◽  
Suicidal Ideation ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Tertiary Care ◽  
Severe Depression ◽  
Care Hospital ◽  
Suicidal Behaviors ◽  
Major Depressive ◽  
Severity Of Depression

Abstract Objectives Mental disorders have a large impact on death by suicide. Hence, this study aims to determine the prevalence of suicidal behaviors among major depressive disorder (MDD) patients and the associated factors. Materials and Methods This cross-sectional analytical study was conducted among individuals aged 18 to 65 years, diagnosed with MDD in the Psychiatry Outpatient Department of a Tertiary Care Center, Puducherry during March to October 2019. Severity of depression was assessed using Hamilton Depression Rating Scale and Columbia-Suicide Severity Rating Scale was used to find the suicidal behaviors. Results For 166 participants in the study, mean (standard deviation) age was 40 (11) years and majority were females (76%). More than one-third (37%) had severe or very severe depression, and the prevalence of suicidal ideation, plan, and attempts were 83, 24, and 35%, respectively. After adjusting the covariates, the severity of depression and unemployment were significantly associated with suicidal attempts (adjusted prevalence ratios [aPR] = 11.4 and 1.9), and very severe depression was associated with suicidal ideation (aPR = 1.6). Among 140 individuals with suicidal ideation, 45 (32%) had an ideation frequency of 2 to 3 times/week, 69 (50%) had ideation for 1 hour, 36 (26%) could control ideation with little difficulty, and 12% had suicidal ideation mostly to end or stop their pain. Conclusion Suicidal ideation and attempts were significantly high in MDD patients, and the severity of depression was significantly associated with it. Early identification of high-risk suicidal behavior and implementation of effective preventive interventions are necessary to reduce death by suicide in these groups.

scholarly journals ‘Tracking Together’—Simultaneous Use of Human and Dog Activity Trackers: Protocol for a Factorial, Randomized Controlled Pilot Trial

2021 ◽  
Vol 18 (4) ◽  
pp. 1561
Author(s):  
Wasantha Jayawardene ◽  
Lesa Huber ◽  
Jimmy McDonnell ◽  
Laurel Curran ◽  
Sarah Larson ◽  
...  
Keyword(s):  
Physical Activity ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Activity Level ◽  
Analysis Of Covariance ◽  
Moderate Intensity ◽  
Randomized Controlled ◽  
Activity Trackers ◽  
Dog Owners ◽  
Simultaneous Use

Dog-walkers are more likely to achieve moderate-intensity physical activity. Linking the use of activity trackers with dog-walking may be beneficial both in terms of improving the targeted behavior and increasing the likelihood of sustained use. This manuscript aims to describe the protocol of a pilot study which intends to examine the effects of simultaneous use of activity trackers by humans and their dogs on the physical activity level of humans and dogs. This study uses nonprobability sampling of dog owners of age 25–65 (N = 80) and involves four parallel groups in an observational randomized controlled trial with a 2 × 2 factorial design, based on use of dog or human activity trackers for eight weeks. Each group consists of dog-human duos, in which both, either or none are wearing an activity tracker for eight weeks. At baseline and end, all human subjects wear ActiGraph accelerometers that quantify physical activity for one week. Commercial activity trackers are used for tracking human and dog activity remotely. Additional measures for humans are body composition and self-reported physical activity. Dog owners also report dog’s weight and physical activity using a questionnaire. A factorial analysis of covariance (ANCOVA) is used to compare physical activity across the four groups from baseline to week-10.

Safety, Tolerability, and Efficacy of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder: Results from Two Open-Label Extension Trials

CNS Spectrums ◽  
2018 ◽  
Vol 24 (5) ◽  
pp. 496-506 ◽  
Author(s):  
Sarah Atkinson ◽  
Louise Thurman ◽  
Sara Ramaker ◽  
Gina Buckley ◽  
Sarah Ruta Jones ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Children And Adolescents ◽  
Rating Scale ◽  
Transition Period ◽  
Extension Study ◽  
Open Label ◽  
Major Depressive ◽  
Children’S Depression ◽  
Flexible Dose

ObjectiveTwo similarly designed extension studies evaluated the long-term safety and tolerability of desvenlafaxine for the treatment of children and adolescents with major depressive disorder (MDD). Efficacy was evaluated as a secondary objective.MethodsBoth 6-month, open-label, flexible-dose extension studies enrolled children and adolescents who had completed one of two double-blind, placebo-controlled, lead-in studies. One lead-in study included a 1-week transition period prior to the extension study. Patients received 26-week treatment with flexible-dose desvenlafaxine (20–50 mg/d). Safety assessments included comprehensive psychiatric evaluations, vital sign assessments, laboratory evaluations, 12-lead electrocardiogram, physical examination with Tanner assessment, and Columbia-Suicide Severity Rating Scale. Adverse events (AEs) were collected throughout the studies. Efficacy was assessed using the Children’s Depression Rating Scale–Revised (CDRS-R).ResultsA total of 552 patients enrolled (completion rates: 66.4 and 69.1%). AEs were reported by 79.4 and 79.1% of patients in the two studies; 8.9 and 5.2% discontinued due to AEs. Treatment-emergent suicidal ideation or behavior was reported for 16.6 and 14.1% of patients in the two studies. Mean (SD) CDRS-R total score decreased from 33.83 (11.93) and 30.92 (10.20) at the extension study baseline to 24.31 (7.48) and 24.92 (8.45), respectively, at week 26.ConclusionDesvenlafaxine 20 to 50 mg/d was generally safe and well tolerated with no new safety signals identified in children and adolescents with MDD who received up to 6 months of treatment in these studies. Patients maintained the reduction in severity of depressive symptoms observed in all treatment groups at the end of the lead-in study.

Escitalopram Versus SNRI Antidepressants in the Acute Treatment of Major Depressive Disorder: Integrative Analysis of Four Double-Blind, Randomized Clinical Trials

CNS Spectrums ◽  
2009 ◽  
Vol 14 (6) ◽  
pp. 326-333 ◽  
Author(s):  
Susan G. Kornstein ◽  
Dayong Li ◽  
Yongcai Mao ◽  
Sara Larsson ◽  
Henning F. Andersen ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Randomized Clinical Trials ◽  
Rating Scale ◽  
Severe Depression ◽  
Major Depressive ◽  
Double Blind ◽  
Madrs Score ◽  
Treatment Difference

AbstractIntroduction: Recent data suggest that escitalopram may be more effective in severe depression than other selective serotonin reuptake inhibitors.Methods: Individual patient data from four randomized, double-blind comparative trials of escitalopram versus a serotonin/norepinephrine reuptake inhibitor (SNRI) (two trials with duloxetine and two with venlafaxine extended release) in outpatients (18–85 years of age) with moderate-to-severe major depressive disorder were pooled. The primary efficacy parameter in all four trials was mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) score.Results: Significantly fewer escitalopram (82/524) than SNRI (114/527) patients prematurely withdrew from treatment due to all causes (15.6% vs. 21.6%, Fisher Exact: P=.014) and adverse events (5.3% vs. 12.0%, Fisher Exact: P <.0001). Mean reduction in MADRS score from baseline to Week 8 was significantly greater for the escitalopram group versus the SNRI group using the last observation carried forward (LOCF) approach [mean treatment difference at Week 8 of 1.7 points (P <.01)]. Similar results were observed in the severely depressed (baseline MADRS score ≥30) patient subset (mean treatment difference at Week 8 of 2.9 points [P <.001, LOCF]). Observed cases analyses yielded no significant differences in efficacy parameters.Conclusion: This pooled analysis indicates that escitalopram is at least as effective as the SNRIs (venlafaxine XR and duloxetine), even in severe depression, and escitalopram treatment was better tolerated.

Effectiveness of mirtazapine as add-on to paroxetine v. paroxetine or mirtazapine monotherapy in patients with major depressive disorder with early non-response to paroxetine: a two-phase, multicentre, randomized, double-blind clinical trial

2020 ◽  
pp. 1-9 ◽  
Author(s):  
Le Xiao ◽  
Xuequan Zhu ◽  
Amy Gillespie ◽  
Yuan Feng ◽  
Jingjing Zhou ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Antidepressant Treatment ◽  
Additional Treatment ◽  
Combination Group ◽  
Open Label ◽  
Major Depressive ◽  
Double Blind ◽  
Early Improvement

Abstract Background This study aimed to examine the efficacy of combining paroxetine and mirtazapine v. switching to mirtazapine, for patients with major depressive disorder (MDD) who have had an insufficient response to SSRI monotherapy (paroxetine) after the first 2 weeks of treatment. Methods This double-blind, randomized, placebo-controlled, three-arm study recruited participants from five hospitals in China. Eligible participants were aged 18–60 years with MDD of at least moderate severity. Participants received paroxetine during a 2-week open-label phase and patients who had not achieved early improvement were randomized to paroxetine, mirtazapine or paroxetine combined with mirtazapine for 6 weeks. The primary outcome was improvement on the Hamilton Rating Scale for Depression 17-item (HAMD-17) scores 6 weeks after randomization. Results A total of 204 patients who showed early non-response to paroxetine monotherapy were randomly assigned to receive either mirtazapine and placebo (n = 68), paroxetine and placebo (n = 68) or mirtazapine and paroxetine (n = 68), with 164 patients completing the outcome assessment. At week 8, the least squares (LS) mean change of HAMD-17 scores did not significantly differ among the three groups, (12.98 points) in the mirtazapine group, (12.50 points) in the paroxetine group and (13.27 points) in the mirtazapine plus paroxetine combination group. Participants in the paroxetine monotherapy group were least likely to experience adverse effects. Conclusions After 8 weeks follow-up, paroxetine monotherapy, mirtazapine monotherapy and paroxetine/mirtazapine combination therapy were equally effective in non-improvers at 2 weeks. The results of this trial do not support a recommendation to routinely offer additional treatment or a switch in treatment strategies for MDD patients who do not show early improvement after 2 weeks of antidepressant treatment.

Combined treatment with reboxetine in depressed patients with no response to venlafaxine: a 6-week follow-up study

2007 ◽  
Vol 19 (5) ◽  
pp. 291-296 ◽  
Author(s):  
Cecilio Álamo ◽  
Francisco López-Muñoz ◽  
Gabriel Rubio ◽  
Pilar García-García ◽  
Antonio Pardo
Keyword(s):  
Adverse Events ◽  
Rating Scale ◽  
Combined Treatment ◽  
Open Label ◽  
Serious Adverse Events ◽  
Multicentric Study ◽  
Intent To Treat ◽  
Events Data ◽  
Clinical Global Impression Improvement

Objective:The purpose of present study was to evaluate the efficacy of the addition of reboxetine in patients that had not previously responded, or had done so only partially, over 6 weeks of conventional pharmacological treatment with venlafaxine.Methods:This open-label, prospective and multicentric study included 40 outpatients diagnosed with major depressive disorder according to the DSM-IV criteria. Efficacy was assessed using the 21-item Hamilton Depression Rating Scale (HAMD) and the Clinical Global Impression-Improvement (CGI-I). Safety was evaluated by recording spontaneously reported adverse events. Data were analysed on an intent-to-treat basis, using the last-observation-carried-forward method.Results:Mean HAMD reduction was 34.9% (P < 0.0001). The percentages of responders (≥50% reduction in HAMD) and patients considered as benefiting from complete remission (HAMD ≤ 10 points) at week 6 were 27.5 and 12.5%, respectively. By the end of the treatment, the score of CGI-I decreased 24.8% (P < 0.0001). Percentage of patient improving (CGI < 4 points) was 47.5%. The most common non-serious adverse events were constipation, nervousness, anxiety and insomnia.Conclusion:These findings suggest that the combined treatment of reboxetine and venlafaxine, in venlafaxine-resistant patients, may be an effective and well-tolerated strategy.

scholarly journals Pilot trial on the efficacy and safety of pantethine in children with pantothenate kinase-associated neurodegeneration: A single-arm, open-label study.

2020 ◽  
Author(s):  
Xuting Chang ◽  
Jie Zhang ◽  
Yuwu Jiang ◽  
Bufan Yao ◽  
Jingmin Wang ◽  
...  
Keyword(s):  
Rating Scale ◽  
Pilot Trial ◽  
Motor Dysfunction ◽  
Efficacy And Safety ◽  
Open Label ◽  
Pantothenate Kinase ◽  
Open Label Study ◽  
Label Study ◽  
Video Assessment

Abstract Objective This study aimed to explore the efficacy and safety of pantethine in children with pantothenate kinase-associated neurodegeneration (PKAN).Methods A single-arm, open-label study was conducted. All subjects received pantethine during the 24-week period of treatment. The primary endpoints were change of the Unified Parkinson’s Disease Rating Scale (UPDRS) I–III and Fahn–Marsden (FM) score from baseline to week 24 after treatment.Results Fifteen children with PKAN were enrolled, and all patients completed the study. After 24 weeks of treatment with pantethine at 60 mg/kg per day, there was no difference in either UPDRS I–III (t = 0.516, P = 0.614) or FM score (t = 0.353, P = 0.729) between the baseline and W24. Whereas the rates of increase in UPDRS I-III (Z = 2.614, p = 0.009) and FM scores (Z = 2.643, p = 0.008) were slowed. Four patients (26.7%) were evaluated as “slightly improved” by doctors through blinded video assessment. Patients with lower baseline UPDRS I–III or FM scores were more likely to be improved. The living quality of family members improved after pantethine treatment, evaluated by PedsQL TM 2.0 FIM scores, whereas the living quality of the patients was unchanged at W24, evaluated by PedsQL TM 4.0 and PedsQL TM 3.0 NMM. Serum level of CoA was comparable between baseline and W24. There was no drug related adverse event during the study.Conclusions Pantethine could not significantly improve motor function in children with PKAN after 24 weeks treatment, but it could probably delay the progression of motor dysfunction in our study. 26.7% of patients showed slightly improved. Pantethine was well-tolerated at 60 mg/kg per day.

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