Major depressive disorder, anhedonia, and agomelatine: An open-label study

2011 ◽  
Vol 26 (S2) ◽  
pp. 650-650 ◽  
Author(s):  
G. Martinotti ◽  
G. Di Iorio ◽  
R. Guglielmo ◽  
D. De Berardis ◽  
L. Janiri ◽  
...  
Keyword(s):  
Depressive Disorders ◽  
Rating Scale ◽  
Antidepressant Drugs ◽  
Depression Scale ◽  
Early Response ◽  
Hamilton Depression Scale ◽  
Open Label ◽  
Major Depressive ◽  
Secondary Endpoints ◽  
Hamilton Anxiety Scale

IntroductionToday there is a large number of antidepressant drugs. However, the effect of treatment is often suboptimal. Unlike other antidepressants agomelatine has a novel neurochemical mechanism. It is an MT1 and MT2 melatonergic receptor agonist and a selective antagonist of the 5-HT2C receptors. In this open-label 8-week study we aimed to investigate the efficacy of agomelatine on depressive symptoms in patients with major depression. Secondary endpoints were the effect of agomelatine on anhedonia.MethodsThirty major depressive patients received a flexible dose (25–50 mg; per os, daily) of agomelatine. Depressive (Hamilton Depression Scale) and anxious (Hamilton Anxiety Scale) symptoms, anhedonia (Snaith Hamilton Rating Scale), and sleep quality (Leeds Sleep Evaluation Questionnaire) were assessed.ResultsTwenty-four patients (80%) completed 8 weeks of treatment. Significant improvements were seen at all visits on the HAM-D (p< .05), HAM-A(p< .01), SHAPS (p< .05), LSEQ (p< .05). Nine subjects (30%) were responders and 5 (17%) remitters at week 1; 18 (60%) were remitters by the end of the trial. There was no serious adverse event. No aminotrasferase elevations were noted.DiscussionIn line with previous studies, in which agomelatine was associated with early clinical improvement this study also provides evidence of an early response and the findings of improvements in depression scores. Beside this is the first study where agomelatine was effective in the treatment of anhedonia. Additional trials are needed to delineate the place of agomelatine in the contemporary pharmacotherapy for depressive disorders.

scholarly journals An Open-Label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults with Parkinson’s Disease and Depression

2020 ◽  
Vol 10 (4) ◽  
pp. 1751-1761
Author(s):  
Daryl DeKarske ◽  
Gustavo Alva ◽  
Jason L. Aldred ◽  
Bruce Coate ◽  
Marc Cantillon ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Adverse Events ◽  
Reuptake Inhibitor ◽  
Adjunctive Therapy ◽  
Rating Scale ◽  
Depression Scale ◽  
System Organ Class ◽  
Hamilton Depression Scale ◽  
Open Label

Background: Many patients with Parkinson’s disease (PD) experience depression. Objective: Evaluate pimavanserin treatment for depression in patients with PD. Methods: Pimavanserin was administered as monotherapy or adjunctive therapy to a selective serotonin reuptake inhibitor or serotonin/noradrenaline reuptake inhibitor in this 8-week, single-arm, open-label phase 2 study (NCT03482882). The primary endpoint was change from baseline to week 8 in Hamilton Depression Scale–17-item version (HAMD-17) score. Safety, including collection of adverse events and the Mini-Mental State Examination (MMSE) and Movement Disorder Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale Part III (MDS-UPDRS III) scores, was assessed in patients who received ≥1 pimavanserin dose. Results: Efficacy was evaluated in 45 patients (21 monotherapy, 24 adjunctive therapy). Mean (SE) baseline HAMD-17 was 19.2 (3.1). Change from baseline to week 8 (least squares [LS] mean [SE]) in the HAMD-17 was –10.8 (0.63) (95% CI, –12.0 to –9.5; p < 0.0001) with significant improvement seen at week 2 (p < 0.0001) and for both monotherapy (week 8, –11.2 [0.99]) and adjunctive therapy (week 8,–10.2 [0.78]). Most patients (60.0%) had ≥50% improvement at week 8, and 44.4% of patients reached remission (HAMD-17 score ≤7). Twenty-one of 47 patients experienced 42 treatment-emergent adverse events; the most common by system organ class were gastrointestinal (n = 7; 14.9%) and psychiatric (n = 7; 14.9%). No negative effects were observed on MMSE or MDS-UPDRS Part III. Conclusion: In this 8-week, single-arm, open-label study, pimavanserin as monotherapy or adjunctive therapy was well tolerated and associated with early and sustained improvement of depressive symptoms in patients with PD.

scholarly journals Reduced Plasma Levels of α-Klotho and Their Correlation With Klotho Polymorphisms in Elderly Patients With Major Depressive Disorders

2021 ◽  
Vol 12 ◽  
Author(s):  
Xiang Gao ◽  
Zuoli Sun ◽  
Guangwei Ma ◽  
Yuhong Li ◽  
Min Liu ◽  
...  
Keyword(s):  
Genetic Polymorphisms ◽  
Disease Severity ◽  
Depressive Disorders ◽  
Transmembrane Protein ◽  
Depression Scale ◽  
The Elderly ◽  
First Episode ◽  
Hamilton Depression Scale ◽  
Major Depressive ◽  
Major Depressive Disorders

Background: Recent literature suggests that α-Klotho, a widely recognized anti-aging protein, is involved in longevity as well as in many diseases, including Alzheimer's disease, and depression. Although the Klotho gene encodes α-Klotho, a single transmembrane protein with intracellular and extracellular domains, the relationship between Klotho gene polymorphism and circulating α-Klotho levels in patients with major depressive disorder (MDD) is not clear.Methods: A total of 144 MDD patients and 112 age-matched healthy controls were included in this study. The Klotho genetic polymorphisms (rs9536314, rs9527025, and rs9315202) and plasma α-Klotho levels were measured by PCR and ELISA, respectively. The severity of depressive symptoms was estimated using the Hamilton Depression Scale (HAMD).Results: We found a significantly lower level of plasma α-Klotho in the MDD patients than in controls. Among them, only elderly MDD patients (first episode) showed significantly lower α-Klotho levels than the age-matched controls, while elderly recurrent and young MDD patients showed no difference in plasma α-Klotho levels from age-matched controls. The young MDD group showed a significantly earlier onset age, higher plasma α-Klotho levels, and lower HAMD scores than those in the elderly MDD group. While the plasma α-Klotho levels were higher in rs9315202 T alleles carrier regardless age or sex, the rs9315202 T allele was negatively correlated with disease severity only in the elderly MDD patients.Conclusion: The results of our study showed that only elderly MDD patients showed a decrease in plasma α-Klotho levels along with an increase in disease severity as well as an association with the number of rs9315202 T alleles, and not young MDD patients compared to age-matched controls. Our data suggest that circulating α-Klotho levels combined with Klotho genetic polymorphisms are important in elderly MDD patients, particularly carriers of the Klotho gene rs9315202 T allele.

scholarly journals Effects of agomelatine and mirtazapine on sleep disturbances in major depressive disorder: evidence from polysomnographic and resting-state functional connectivity analyses

SLEEP ◽  
2020 ◽  
Vol 43 (11) ◽  
Author(s):  
Wei-Feng Mi ◽  
Serik Tabarak ◽  
Li Wang ◽  
Su-Zhen Zhang ◽  
Xiao Lin ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Functional Connectivity ◽  
Depressive Disorder ◽  
Sleep Disturbances ◽  
Rating Scale ◽  
Sleep Onset ◽  
Depression Scale ◽  
Hamilton Depression Scale ◽  
Major Depressive ◽  
Depressed Patients

Abstract To investigate effects of agomelatine and mirtazapine on sleep disturbances in patients with major depressive disorder. A total of 30 depressed patients with sleep disturbances, 27 of which completed the study, took agomelatine or mirtazapine for 8 weeks. Subjective scales were administered, and polysomnography was performed at baseline and at the end of week 1 and 8. Functional magnetic resonance imaging was performed at baseline and at the end of week 8. Compared with baseline, scores on the Hamilton Depression Scale, Hamilton Anxiety Scale, Pittsburgh Sleep Quality Index, Sleep Dysfunction Rating Scale, and Insomnia Severity Index after 8 weeks of treatment significantly decreased in both groups, with no significant differences between groups, accompanied by significant increases in total sleep time, sleep efficiency, and rapid eye movement (REM) sleep and significant decrease in wake after sleep onset. Mirtazapine treatment increased N3 sleep at week 1 compared with agomelatine treatment, but this difference disappeared at week 8. The increases in the percentage and duration of N3 sleep were positively correlated with increases in connectivity between right dorsal lateral prefrontal cortex (dlPFC) and right precuneus and between left posterior cingulate cortex and right precuneus in both groups, respectively. Functional connectivity (FC) between right dlPFC and left precuneus in mirtazapine group was higher compared with agomelatine group after 8 weeks of treatment. These findings indicated that both agomelatine and mirtazapine improved sleep in depressed patients, and the effect of mirtazapine was greater than agomelatine with regard to rapidly increasing N3 sleep and gradually improving FC in the brain.

What do Clinical Trials Tell us About Antidepressant Delayed Onset of Action?

2017 ◽  
Vol 41 (S1) ◽  
pp. S3-S4
Author(s):  
J. Rabinowitz
Keyword(s):  
Rating Scale ◽  
Antidepressant Treatment ◽  
Antidepressant Drugs ◽  
Depression Scale ◽  
Self Report ◽  
Symptom Improvement ◽  
Controlled Trials ◽  
Hamilton Depression Scale ◽  
Onset Of Action ◽  
Individual Patient Level

Response to antidepressants in major depressive disorder is highly variable and determinants are not well understood. Presentation will provide clinical trial data on time to response and determinants of response to antidepressant treatment. Data is from the Innovative Medicines Initiative funded NEWMEDS collaboration, a large public-private collaboration which assembled the largest dataset of individual patient level information from randomized placebo-controlled trials of antidepressant drugs. Studies were conducted by four large pharmaceutical companies. Dataset includes placebo-controlled trials of citalopram, duloxetine, escitalopram, quetiapine and sertraline in adults with MDD. We examined patient and trial-design-related determinants of outcome as measured by change on Hamilton Depression Scale or Montgomery–Asberg Depression Rating Scale in 34 placebo-controlled trials (drug, n = 8260; placebo, n = 3957). While it is conventional for trials to be 6–8 weeks long, data presented will show that drug-placebo differences were observable at week 4 with nearly the same sensitivity and lower dropout rates. Having any of these attributes was significantly associated with greater drug vs. placebo differences on symptom improvement: female, patients being middle aged, increasing proportion of patients on placebo, excluding all patients from centers with high placebo response regardless of active treatment response, using active run in periods and including self-report measures. Proof of concept trials can be shorter and efficiency improved by selecting enriched populations based on clinical and demographic variables, ensuring adequate balance of placebo patients, and carefully selecting and monitoring centers. In addition to improving drug discovery, patient exposure to placebo and experimental treatments can be reduced.Disclosure of interestI have received research grant(s) support and/or travel support and/or speaker fees and/or consultant fees from Takeda, Minerva, Intra-cellular Therapies, Janssen (J&J), Eli Lilly, Pfizer, BiolineRx, Roche, Abraham Pharmaceuticals, Pierre Fabre, Minerva and Amgen.

scholarly journals Counterfactual Thinking-Related Emotional Responses in Patients With Major Depressive Disorder

2021 ◽  
Vol 11 ◽  
Author(s):  
Qi Zheng ◽  
Mei Liao ◽  
Bangshan Liu ◽  
WenWen Ou ◽  
WenTao Chen ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Demographic Data ◽  
Depression Scale ◽  
Counterfactual Thinking ◽  
Hamilton Depression Scale ◽  
Gambling Task ◽  
Major Depressive ◽  
Significant Difference

Objective: To explore the emotional characteristics of counterfactual thinking (CT)-related emotion responses in patients with major depressive disorder (MDD) via the “counterfactual thinking gambling task (CTGT).”Method: Twenty-five patients with MDD (the MDD group) and twenty-five healthy controls (the HC group) with matched demographic features were included. The 17-item Hamilton Depression Scale (HAMD) and the 14-item Hamilton Anxiety Rating Scale (HAMA) were used to assess the severity of depression and anxiety symptoms. The counterfactual thinking gambling task was applied to assess the situation-focused- and behavior-focused-CT-related emotion responses in the MDD group and the HC group.Results: There was no significant difference in general demographic data between the two groups (p &gt; 0.05). Compared with the HC group, the MDD group experienced higher levels of “disappointment” and lower levels of “joy” in the situation-focused CT paradigm (p &lt; 0.05). However, the experience of “regret” and “relief” in the behavior-focused CT paradigm were not significantly different between the two groups (p &gt; 0.05).Conclusions: MDD is associated with an impaired situation-focused-CT-related emotion responses, and is often accompanied by increased disappointment and decreased joy; however, behavior-focused-CT-related emotion responses are not significantly affected in MDD. This pattern may represent the characteristic CT-related emotion responses of MDD.

The Major Depressive Disorder Hierarchy: Rasch Analysis of 6 Items of the Hamilton Depression Scale Covering the Continuum of Depressive Syndrome

2017 ◽  
Vol 41 (S1) ◽  
pp. s244-s244
Author(s):  
L. Primo de Carvalho Alves ◽  
M. Pio de Almeida Fleck ◽  
A. Boni ◽  
N. Sica da Rocha
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Depressed Mood ◽  
Rasch Analysis ◽  
Rating Scale ◽  
Depression Scale ◽  
Psychomotor Retardation ◽  
Model Fit ◽  
Hamilton Depression Scale ◽  
Major Depressive

ObjectivesMelancholic features of depression (MFD) seem to be a unidimensional group of signs and symptoms. However, little importance has been given to the evaluation of what features are related to a more severe disorder. That is, what are the MFD that appear only in the most depressed patients. We aim to demonstrate how each MFD is related to the severity of the major depressive disorder.MethodsWe evaluated both the Hamilton depression rating scale (HDRS-17) and its 6-item melancholic subscale (HAM-D6) in 291 depressed inpatients using Rasch analysis, which computes the severity of each MFD. Overall measures of model fit were mean ( ± SD) of items and persons residual = 0 (± 1); low χ2 value; P > 0.01.ResultsFor the HDRS–17 model fit, mean (± SD) of item residuals = 0.35 (± 1.4); mean (± SD) of person residuals = –0.15 (± 1.09); χ2 = 309.74; P < 0.00001. For the HAM-D6 model fit, mean (± SD) of item residuals = 0.5 (± 0.86); mean (± SD) of person residuals = 0.15 (± 0.91); χ2 = 56.13; P = 0.196. MFD ordered by crescent severity were depressed mood, work and activities, somatic symptoms, psychic anxiety, guilt feelings, and psychomotor retardation.ConclusionsDepressed mood is less severe, while guilt feelings and psychomotor retardation are more severe MFD in a psychiatric hospitalization. Understanding depression, as a continuum of symptoms can improve the understanding of the disorder and may improve its perspective of treatment.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Assessment of brain functional connectome alternations and correlation with depression and anxiety in major depressive disorders

PeerJ ◽  
2017 ◽  
Vol 5 ◽  
pp. e3147 ◽  
Author(s):  
Vincent Chin-Hung Chen ◽  
Chao-Yu Shen ◽  
Sophie Hsin-Yi Liang ◽  
Zhen-Hui Li ◽  
Ming-Hong Hsieh ◽  
...  
Keyword(s):  
Resting State ◽  
Depressive Disorders ◽  
Rating Scale ◽  
Depression Scale ◽  
Low Frequency ◽  
Resting State Fmri ◽  
Clustering Coefficient ◽  
Major Depressive ◽  
Potential Biomarker ◽  
Major Depressive Disorders

Major depressive disorder (MDD) is highly prevalent, recurrent, and associated with functional impairment, morbidity, and mortality. Herein, we aimed to identify disruptions in functional connectomics among subjects with MDD by using resting-state functional magnetic resonance imaging (rs-fMRI). Sixteen subjects with MDD and thirty health controls completed resting-state fMRI scans and clinical assessments (e.g., Hamilton Depression Rating Scale (HAMD) and Hospital Anxiety and Depression Scale (HADS)). We found higher amplitude of low frequency fluctuations (ALFF) bilaterally in the hippocampus and amygdala among MDD subjects when compared to healthy controls. Using graph theoretical analysis, we found decreased clustering coefficient, local efficiency, and transitivity in the MDD patients. Our findings suggest a potential biomarker for differentiating individuals with MDD from individuals without MDD.

scholarly journals Exploratory Study of the Diagnostic Abilities of the Baptista Depression Scale Adult Version (EBADEP-A)

2013 ◽  
Vol 23 (56) ◽  
pp. 301-311 ◽  
Author(s):  
Makilim Nunes Baptista ◽  
Juliana Oliveira Gomes ◽  
Adriana Munhoz Carneiro
Keyword(s):  
Depressive Disorders ◽  
Screening Tool ◽  
Depression Scale ◽  
Depression Screening ◽  
Hamilton Depression Scale ◽  
Major Depressive ◽  
Diagnostic Instruments ◽  
Dsm Iv ◽  
Diagnostic Capabilities ◽  
Screening Scale

This study’s objective was to analyze the diagnostic capabilities of a depression screening scale. For that, this scale was administered along with two diagnostic instruments, namely, the structured clinical interview from the DSM-IV (SCID-CV) and the Hamilton Depression Scale (HAM-D), which are considered to be the gold standard for diagnosing depressive disorders. Participants were 22 subjects diagnosed by psychiatrists with Major Depressive Disorder. The EBADEP-A correctly identified cases of depression, showing a high correlation with the HAM-D, which indicates the scale correctly captures most depressive symptoms, even though it was initially used as a depression-screening tool.

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.

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