scholarly journals Rosiglitazone Add-On in Treatment of Depressed Patients with Insulin Resistance: a Pilot Study

2010 ◽  
Vol 10 ◽  
pp. 321-328 ◽  
Author(s):  
Natalie L. Rasgon ◽  
Heather A. Kenna ◽  
Katherine E. Williams ◽  
Bevin Powers ◽  
Tonita Wroolie ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Pilot Study ◽  
Depressive Disorders ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Depression Severity ◽  
Open Label ◽  
Modest Improvement ◽  
Severity Scores ◽  
Matsuda Index

A number of cross-sectional studies have suggested an association between insulin resistance (IR) and affective disorders. However, limited data exist on potential changes in IR in a prospective treatment of depression. The present pilot study tested the hypothesis that improvement of IR with the addition of an insulin-sensitizing agent would improve mood in nondiabetic patients with unipolar or bipolar depression, who had surrogate blood markers suggestive of IR. Surrogate IR-criteria blood markers were fasting plasma glucose >100 mg/dl or triglyceride (TG) to high density lipoprotein (HDL) ratio >3.0. Open-label rosiglitazone, titrated to a dose of 8 mg/day, was administered for 12 weeks to 12 patients with depressive disorder receiving treatment as usual (TAU). Eight patients who completed the 12-week study exhibited significant declines in both depression severity by the Hamilton Depression Rating Scale and the Clinical Global Impression scale, with moderate effect sizes noted. Modest improvement in Matsuda Index scores was also noted at 12 weeks, yet declines in depression severity scores were not associated with improvements in the endocrine markers (Matsuda Index, TG/HDL ratio, and body mass index). These results suggest the potential novel use for an insulin-sensitizing agent in the treatment of depressive disorders. Larger placebo-controlled studies are warranted.

scholarly journals Preliminary Pharmacogenetic Study to Explore Putative Dopaminergic Mechanisms of Antidepressant Action

2021 ◽  
Vol 11 (8) ◽  
pp. 731
Author(s):  
Taichi Ochi ◽  
Natalya M. Vyalova ◽  
Innokentiy S. Losenkov ◽  
Diana Z. Paderina ◽  
Ivan V. Pozhidaev ◽  
...  
Keyword(s):  
Depressive Disorders ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Sufficient Evidence ◽  
Therapeutic Effects ◽  
Pharmacogenetic Study ◽  
Dopaminergic Mechanisms ◽  
Major Depressive Disorders ◽  
Related Proteins ◽  
Antidepressant Action

Background: There is sufficient evidence that interference of dopaminergic neurotransmission contributes to the therapeutic effects of antidepressants in unipolar and bipolar depression. Methods: Hamilton depression rating scale (HAMD 17) scores of 163 at least moderately ill patients with major depressive disorders were used to establish treatment response. HAMD 17 score status was measured before initiation, after two weeks, and after four weeks of treatment with various antidepressants. The possible association between response and genotype in a total of 14 variants of dopamine neurotransmission-related proteins was investigated. Results: DRD4 rs11246226 CA heterozygous patients were found with a greater improvement of HAMD 17 score when compared to homozygous C patients during 0–2 weeks and 0–4 weeks. Patients with MAOB rs1799836 heterozygous GA and homozygous A also demonstrated improved scores during 2–4 weeks and 0–4 weeks. Conclusions: The results are preliminary due to the limited population size and the small number of variants. Further research into the involvement of habenular dopamine D4 receptors in the antidepressant response is desirable.

scholarly journals StopWatch: Pilot study for an Apple Watch application for youth with ADHD

2021 ◽  
Vol 7 ◽  
pp. 205520762110012
Author(s):  
John E Leikauf ◽  
Carlos Correa ◽  
Andrew N Bueno ◽  
Vicente Peris Sempere ◽  
Leanne M Williams
Keyword(s):  
Pilot Study ◽  
Mixed Models ◽  
Rating Scales ◽  
Haptic Feedback ◽  
Rating Scale ◽  
Open Label ◽  
Software Application ◽  
Hyperactivity Disorder ◽  
Further Development ◽  
Youth With Adhd

Introduction To address the need for non-pharmacologic, scalable approaches for managing attention-deficit and hyperactivity disorder (ADHD) in young people, we report the results of a study of an application developed for a wearable device (Apple Watch) that was designed to track movement and provide visual and haptic feedback for ADHD. Methods Six-week, open label pilot study with structured rating scales ADHD and semi-structured qualitative interview. Apple Watch software application given to users that uses actigraphy and graphic interface as well as haptic feedback to provide feedback to users about level of movement during periods of intentional focus. Linear mixed models to estimate trajectories. Results Thirty-two participants entered the study. This application was associated with improvement in ADHD symptoms over the 6 weeks of the study. We observed an ADHD-Rating Scale change of β = −1.2 units/week (95% CI = −0.56 to −1.88, F = 13.4, P = .0004). Conclusions These positive clinical outcomes highlight the promise of such wearable applications for ADHD and the need to pursue their further development.

scholarly journals Plasma exchange with albumin replacement and disease progression in amyotrophic lateral sclerosis: a pilot study

2021 ◽  
Author(s):  
Mónica Povedano ◽  
Andrés Paipa ◽  
Miquel Barceló ◽  
Michael K. Woodward ◽  
Sandra Ortega ◽  
...  
Keyword(s):  
Amyotrophic Lateral Sclerosis ◽  
Pilot Study ◽  
Disease Progression ◽  
Plasma Exchange ◽  
Rating Scale ◽  
Open Label ◽  
Primary Endpoints ◽  
Rate Of Decline ◽  
Post Hoc ◽  
Lateral Sclerosis

Abstract Background Plasma exchange (PE) is used to treat a range of neurological disorders. Based on results demonstrated in Alzheimer’s disease, we theorized that PE with albumin replacement (PE-A) might alter the metabolic profile of plasma and cerebrospinal fluid in patients with amyotrophic lateral sclerosis (ALS) by removing disease-inducing molecules. The aim of this study was to evaluate the effect of PE-A on disease progression in ALS. Methods In this open-label, non-controlled, single-arm, prospective pilot study, 13 adults with ALS had 6 months’ treatment with PE-A 5% and 6 months’ follow-up. Primary endpoints were changes from baseline in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score and forced vital capacity (FVC) through 48 weeks. A post hoc analysis compared individual patient data with the expected ALSFRS-R progression slope. Results The median ALSFRS-R score declined throughout the study, although the rate of decline was slower than expected in seven patients at treatment end and in five patients at study end. Six patients remained in the same baseline slope progression category, and four patients improved their slope category at treatment end. Median FVC decreased significantly during the study. Treatment was well tolerated. Of 330 PE-A procedures, 0.9% were associated with potentially related adverse events. Conclusion Although functional impairment progressed, about two-thirds of patients showed a slower than expected rate of decline at treatment end. Most patients had unaltered (54.5%) or reduced (36.4%) ALSFRS-R slope progression at treatment end. Further evaluation of PE-A in controlled studies involving more patients is warranted. EudraCT number 2013-004842-40. Trial registration ClinicalTrials.gov identifier: NCT02479802.

Longitudinal assessment of disability amongst patients of bipolar and unipolar depressive disorders presenting to a tertiary care center in North India

2022 ◽  
pp. 002076402110701
Author(s):  
Rajesh Sagar ◽  
Mahadev Singh Sen ◽  
Nand Kumar ◽  
Nishtha Chawla
Keyword(s):  
Depressive Disorders ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Disability Evaluation ◽  
Care Center ◽  
Tertiary Care ◽  
Severity Of Illness ◽  
North India ◽  
Longitudinal Assessment ◽  
Over Time

Objectives: To assess and compare the changes in disability scores associated with Bipolar Depression (BD) and Unipolar Depression (UD) over 1 year. Methods: A longitudinal study was taken up in adults diagnosed with unipolar or bipolar depressive disorder with current depressive episode. Diagnosis was made according to Schedule for Clinical Assessment in Neuropsychiatry. Severity scoring was done using Hamilton’s Depression (HAM-D) rating scale and Hamilton’s Anxiety (HAM-A) rating scale. Disability was assessed using Indian Disability Evaluation and Assessment Scale (IDEAS) and London handicap Scale (LHS) at baseline, 6 and 12 months. Results: Sixty participants were recruited (42 UD and 18 BD). No significant differences were seen in socio-demographic parameters, except higher education levels and males being overrepresented in UD. Significant differences at baseline were seen in HAM-D ( p = .001) and HAM-A ( p = .003) scores. The extent of disability was seen to correlate with severity of illness only in case of BD at baseline. No significant differences were seen in the IDEAS scores at baseline. IDEAS score improved at each follow-up assessment ( p < .001). LHS showed significant improvement over time in UD ( p < .001), but not BD ( p = .076). Percentage individuals meeting cut-off for benchmark disability (>40%) were comparable at baseline but were significantly more in the BD at 12-months ( p = .049). Conclusion and implications: Disability in psychiatry occurs equally amongst unipolar and bipolar depressive disorders and tends to improve over time, although the level of improvement may differ. It may not always correspond to severity of illness. These factors should be considered while certifying disability.

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 A Prospective Pilot Study of Levetiracetam for Body Dysmorphic Disorder

CNS Spectrums ◽  
2009 ◽  
Vol 14 (5) ◽  
pp. 252-260 ◽  
Author(s):  
Katharine A. Phillips ◽  
William Menard
Keyword(s):  
Pilot Study ◽  
Body Dysmorphic Disorder ◽  
Rating Scale ◽  
Primary Outcome Measure ◽  
Obsessive Compulsive ◽  
Open Label ◽  
Double Blind ◽  
The Social ◽  
Scale Scores ◽  
The Mean

ABSTRACTIntroduction: Body dysmorphic disorder (BDD) is an often severe disorder, but few treatment studies have been conducted.Objective: This pilot study explored the efficacy and safety of the antiepileptic medication levetiracetam for BDD.Methods: Seventeen subjects with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition BDD participated in a 12-week open-label levetiracetam trial. Subjects were assessed at regular intervals with standard measures.Results: In intent-to-treat analyses, scores on the Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS), the primary outcome measure, decreased from 32.5±4.7 at baseline to 21.5±11.0 at endpoint (P<.001). Approximately 60% (n=9) of subjects were responders (≥30% decrease on the BDD-YBOCS). The mean time to response was 4.6±2.8 (range: 2-10) weeks. Scores also significantly improved on the Brown Assessment of Beliefs Scale, the Hamilton Rating Scale for Depression, the Global Assessment of Functioning Scale, and the Social and Occupational Functioning Assessment Scale. Scores did not significantly improve on the Quality of Life Enjoyment and Satisfaction Questionnaire, the Beck Anxiety Inventory, or the Social Phobia Inventory. The mean endpoint dose of levetiracetam was 2,044.1±1,065.2 (range: 250–3,000) mg/day, and it was relatively well-tolerated.Conclusion: Randomized, double-blind placebo-controlled studies of levetiracetam for BDD are needed to confirm these preliminary findings.

scholarly journals Relationship of Brain Glutamate Response to D-Cycloserine and Lurasidone to Antidepressant Response in Bipolar Depression: A Pilot Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Zhengchao Dong ◽  
Michael F. Grunebaum ◽  
Martin J. Lan ◽  
Vashti Wagner ◽  
Tse-Hwei Choo ◽  
...  
Keyword(s):  
Rating Scale ◽  
Bipolar Depression ◽  
Anterior Cingulate ◽  
Antidepressant Effect ◽  
Resonance Spectroscopy ◽  
Open Label ◽  
Double Blind ◽  
Open Label Phase ◽  
Relationship Of ◽  
The Impact

N-methyl-D-aspartate glutamate-receptor (NMDAR) antagonists such as ketamine have demonstrated efficacy in both major depressive disorder (MDD) and bipolar disorder depression (BP-D). We have previously reported that reduction in Glx (glutamate + glutamine) in the ventromedial prefrontal cortex/anterior cingulate cortex (vmPFC/ACC), measured by proton magnetic resonance spectroscopy (1H MRS) at 3T during a ketamine infusion, mediates the relationship of ketamine dose and blood level to improvement in depression. In the present study, we assessed the impact of D-cycloserine (DCS), an oral NMDAR antagonist combined with lurasidone in BP-D on both glutamate and Glx. Subjects with DSM-V BP-D-I/II and a Montgomery-Asberg Depression Rating Scale (MADRS) score&gt;17, underwent up to three 1H MRS scans. During Scan 1, subjects were randomized to receive double-blind lurasidone 66 mg or placebo. During Scan 2, all subjects received single-blind DCS 950 mg + lurasidone 66 mg, followed by 4 weeks of open label phase of DCS+lurasidone and an optional Scan 3. Five subjects received lurasidone alone and three subjects received placebo for Scan 1. Six subjects received DCS+lurasidone during Scan 2. There was no significant baseline or between treatment-group differences in acute depression improvement or glutamate response. In Scan 2, after a dose of DCS+lurasidone, peak change in glutamate correlated negatively with improvement from baseline MADRS (r = −0.83, p = 0.04). There were no unexpected adverse events. These preliminary pilot results require replication but provide further support for a link between antidepressant effect and a decrease in glutamate by the NMDAR antagonist class of antidepressants.

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