Escitalopram orally-disintegrating tablets (ODT) in major depression treatment

2016 ◽  
Vol 33 (S1) ◽  
pp. S158-S158
Author(s):  
M. Polikowska ◽  
B. Łoza

IntroductionThe growing rate of depressive disorders causes needs for more effective and more innovative solutions. The modern patients’ challenges make them fail mostly in the treatment compliance. Some reports have described that escitalopram orally disintegrating tablets (ODT) induce faster response and lower dropout rate than oral standard tablets (OST), although both forms have equal bioavailability.AimWe tried to clarify effectiveness rates between escitalopram ODT and OST treatments in depressive patients.MethodAn open-label, 6-month, randomized, flexible-dose study was conducted for direct comparison of the effects of escitalopram ODT (N16) and OST (N15) on dropout rate and clinical outcomes in patients with major depression.ResultsOutcome measures included Hamilton Depression Rating Scale (HDRS), Drug Attitude Inventory-10 (DAI), Clinical Global Improvement Scale (CGI), and Psychological General Well-Being Scale (PGWB). The tolerability was assessed by the UKU scale. No significant difference was found in HDRS, CGI, PGWB and GAF between the two forms of tablets. No significant difference was found in any tolerability rates. However, dropout rate favored escitalopram ODT group (N5, 31.3%) vs escitalopram OST (N7, 47.0%). DAI-10 outcomes, both in patients’ general attitude and subjective feelings, were significantly improved in ODT group (P = 0.000), comparing with OST.DiscussionEscitalopram in its classical form (OST) has become a leader in a group of antidepressants, thanks to safety of use, efficacy and tolerability. In the ODT form, escitalopram can meet additional needs, both clinical and lifestyle. ODT may reduce dropout rate and costs of long-term treatment improving the patients’ compliance.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Author(s):  
Mallikarjuna Rao I. ◽  
Usha Kiran Prayaga ◽  
Dharma Rao Uppada ◽  
Ramachandra Rao E. ◽  
B. L. Kudagi

Background: The SSRIs being used as 1st line therapy in treatment of depression have delayed therapeutic effect which makes the patient vulnerable to an increased risk of suicide and decreased adherence to the treatment and will prematurely discontinue the therapy. The present study was conducted to evaluate if low dose mirtazapine-escitalopram combination therapy has any add on benefit over monotherapy with escitalopram.Methods: In a single-centered, comparative study involving patients with depression attending the out-patient after screening and exclusion, 60 eligible patients were randomly assigned to receive tablet mirtazapine 7.5 mg plus tablet escitalopram 10 mg intervention or tablet escitalopram 10 mg plus placebo intervention in a double-blind 6-week treatment phase. The primary outcome measure was the change in the 17-item Hamilton Depression Rating Scale (HDRS) and Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline. Participants were evaluated at baseline, 1st, 2nd,4th and 6th week. Results were analyzed using Chi-Square test for adverse effects and independent t-test analysis for efficacy parameter.Results: In the analysis of results at 6th week the numbers of patients achieved remission in mirtazapine group are more with a p-value of 0.018 which is significant and the numbers of responders in mirtazapine group are also more which is statistically significant on chi-square test. There is no significant difference was observed between the two groups with reference to occurrence of adverse effect.Conclusions: Adding low dose mirtazapine has an added benefit in terms of efficacy and getting remission early with more number of responders in the treatment of major depression.


2005 ◽  
Vol 18 (4) ◽  
pp. 737-744 ◽  
Author(s):  
F. Gambi ◽  
D. De Berardis ◽  
G. Sepede ◽  
D. Campanella ◽  
N. Galliani ◽  
...  

Hypothalamic pituitary thyroid (HPT) axis abnormalities and alterations in major depression are reported in literature. The aim of our study was to evaluate the effect of mirtazapine on thyroid hormones after 6 months of therapy in a sample of adult outpatients with Major Depression (MD). 17 adult outpatients (7 men, 10 women) with MD according to DSM-IV criteria, were included in the study. All participants had to have met criteria for a major depressive episode with a score of at least 15 on the Hamilton Depression Rating Scale (HAM-D). Fasting venous blood samples were obtained for determination of serum Thyroid Stimulating Hrmone (TSH), Free T3 (FT3) and Free T4 (FT4) concentrations both at baseline and after 6 months of therapy. HAM-D scores decreased significantly from the first day of treatment to the end of the treatment period (p<0.001) and twelve patients (70.6%) were classified as responders. A significant increase in FT3 concentrations was found between baseline and the end of treatment period (P=0.015) whereas FT4 concentrations decreased (P=0.046). No significant changes were found in TSH levels. Higher FT4 concentrations at baseline predicted higher HAM-D scorers both at baseline and at the end of the treatment period. Furthermore, higher FT3 concentrations at endpoint were found to be predictors of lower HAM-D scores. Long-term treatment with mirtazapine increases FT3 levels and decreases FT4 maybe involving the deiodination process of T4 into T3.


2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
L. Mansuy

F2695 is a novel antidepressant exerts simultaneous noradrenergic and serotoninergic neurotransmitter effects.F2695 SR was administered in patients with Major Depression in a randomized, multinational, double-blind, placebo-controlled 10-week study, assessing the efficacy and safety of F2695 SR progressive titration safety adapted doses from 75 mg to 100 mg od, in out-patients with Major Depressive Disorders. The 563 randomized patients fulfilled the diagnostic criteria for Major Depressive Disorders and presented moderate or severe Major Depressive Disorders. Efficacy analysis found a significant difference between F2695 and placebo in favour of the active treatment in term of a significantly greater improvement in MADRS total score with F2695 compared with placebo (p< 0.0001). In addition, significantly more patients achieved MADRS response (a decrease in total score equal or superior to 50%) and MADRS remission (defined as a total score inferiorior to10) in the F2695 group than in the placebo group such an effect being usually not seen on this measure in the relatively short time span of a ten-week study. At the doses tested, F2695 was effective from early in the treatment (week 2) and the difference in efficacy compared with placebo increased steadily throughout the study.The severity to entry in this study was relatively high and the mean MADRS entry score was 31, about 40% of patients were in the severe category of depression.This study: provided evidence of the efficacy of F2695 in major depression population. Therapeutic effect was sustained in term of effect-size, responders and remissions rate, in front of placebo.


2011 ◽  
Vol 26 (S2) ◽  
pp. 1865-1865
Author(s):  
M. Kluge ◽  
P. Schüssler ◽  
M. Dresler ◽  
D. Schmidt ◽  
A. Yassouridis ◽  
...  

IntroductionGhrelin showed antidepressant-like effects in mice. Furthermore, ghrelin influences sleep and the activity of hypothalamic-pituitary-adrenal (HPA) and somatotropic axis in healthy humans as indicated by increased cortisol and growth hormone (GH) plasma levels. Both sleep and the activity of these endocrine axes are disturbed in depression.ObjectiveTo study the effect of ghrelin on psychopathology, sleep and secretion of cortisol and GH in patients with major depression.MethodsDepressive symptoms as assessed by a validated self rating scale (’Befindlichkeits-Skala’, [well-being scale]), secretion profiles of cortisol and GH and sleep-EEGs were determined in 14 unmedicated patients with major depression (7 women) twice, receiving 50 μg ghrelin or placebo at 2200, 2300, 0000, and 0100 hours.ResultsOverall, depressive symptoms did not change significantly after ghrelin administration (placebo: 37 ± 8; ghrelin: 33 ± 10, p = 0.178). However, there was an improvement at trend level in men (placebo: 36 ± 9 to ghrelin: 30 ± 9, p = 0.093) but not in women. In men, ghrelin was associated with less time awake (placebo: 149.0 ± 11.1; ghrelin: 88.0±12.2 min, p = 0.029) and more non-REM sleep (placebo: 263.2 ± 24.1; ghrelin: 304.9 ± 14.1 min, p = 0.027), in women with less REM sleep (placebo: 108.6 ± 15.7; ghrelin: 74.1 ± 13.8 min, p = 0.031) and longer REM latency (placebo: 49.9 ± 6.5; ghrelin: 85.6 ± 14.1 min, p = 0.019). In both sexes, ghrelin caused strong transient increases of GH and cortisol.ConclusionOur study may provide an initial indication that ghrelin can exert antidepressant effects in patients with major depression. Ghrelin strongly affected sleep and secretion of GH and cortisol in a partly different way as previously reported in healthy subjects.


2002 ◽  
Vol 181 (1) ◽  
pp. 29-35 ◽  
Author(s):  
René Klysner ◽  
Jesper Bent-Hansen ◽  
Hanne L. Hansen ◽  
Marianne Lunde ◽  
Elisabeth Pleidrup ◽  
...  

BackgroundThe highly recurrent nature of major depression in the young and the elderly warrants long-term antidepressant treatment.AimsTo compare the prophylactic efficacy of citalopram and placebo in elderly patients; to evaluate long-term tolerability of citalopram.MethodOut-patients, ⩾65 years, with unipolar major depression (DSM – IV: 296.2 x or 296.3 x) and Montgomery – Åsberg Depression Rating Scale score ⩾22 were treated with citalopram 20–40 mg for 8 weeks. Responders continued on their final fixed dose of citalopram for 16 weeks before randomisation to double-blind treatment with citalopram or placebo for at least 48 weeks.ResultsNineteen of the 60 patients using citalopram v. 41 of the 61 patients using placebo had recurrence. Time to recurrence was significantly different between citalopram— and placebo-patients, in favour of citalopram (log-rank test, P < 0.0001). Long-term treatment was well tolerated.ConclusionsLong-term treatment with citalopram is effective in preventing recurrence of depression in the elderly and is well tolerated.


2020 ◽  
pp. 070674372094053
Author(s):  
Arun V. Ravindran ◽  
Martha S. McKay ◽  
Tricia da Silva ◽  
Claudia Tindall ◽  
Tiffany Garfinkel ◽  
...  

Objective: Patients with depression frequently experience persistent residual symptoms even with optimal interventions. These patients often use complementary treatments, including yoga, as a preferred alternative or adjunctive treatment. There is evidence for the benefit of yoga for depression, but this has not been rigorously evaluated, particularly in bipolar depression. We aimed to determine the feasibility and benefit of manualized breathing-focused yoga in comparison to psychoeducation as augmentation to pharmacotherapy for improving residual symptoms of depression in unipolar and bipolar patients. Methods: Using a randomized single-blind crossover design, 72 outpatients with unipolar or bipolar depression were augmented with the two 8-week interventions at separate times, as add-ons to current first-line antidepressants and mood stabilizers. The primary outcome measure was the Montgomery-Åsberg Depression Rating Scale (MADRS). Due to the high dropout of participants after crossover at Week 8, analysis focused on between-group comparisons of yoga and psychoeducation during the initial 8 weeks of the study. Results: There was a significant decline in depressive symptoms, as measured by the MADRS, following 8 weeks of yoga. However, there was no significant difference in MADRS ratings between intervention groups. Similar improvements in self-rated depressive symptoms and well-being were also observed across time. Conclusions: Both yoga and psychoeducation may improve residual symptoms of unipolar and bipolar depression as add-on to medications. In-class group sessions and long study durations may reduce feasibility for this population. Larger trials with parallel group design and shorter duration may be more feasible.


2016 ◽  
Vol 33 (S1) ◽  
pp. S405-S406
Author(s):  
W.M. Bahk ◽  
I.H. Shim ◽  
Y.S. Woo ◽  
S.Y. Lee ◽  
Y.J. Kwon ◽  
...  

IntroductionThis study assessed the levels of immune factors, demographic and clinical characteristics, and pharmacological treatments of patients with depressive disorders and compared them between patients with mild-to-moderate and moderate/severe-to-severe anxiety.MethodsThis study included 177 patients diagnosed with a depressive disorder who were hospitalized between March 2012 and April 2015. The patients were categorized into mild-to-moderate anxious distress and moderate/severe-to-severe anxious distress groups, based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) based on the “with anxious distress” specifier. The current severity of symptoms was determined using the Hamilton Depression Rating Scale (HAM-D) scores on the Agitation and Anxiety-Psychic subscales. The charts of the patients were reviewed to evaluate immune factors, including C-reactive protein (CRP) and white blood cell (WBC) levels, confounding factors, such as smoking, other general medical disorders, and body mass index (BMI), and demographic and clinical characteristics.ResultsThe moderate–severe to severe anxious distress group tended to have higher CRP and monocyte levels compared with the mild to moderate anxious distress group. However, after adjusting for the total HAM-D scores, there was a significant difference only in monocyte levels. After this adjustment, patients with moderate–severe to severe anxious distress had a significantly greater trend toward significance for suicidality and a higher rate of antipsychotic use.ConclusionsHigh levels of anxiety symptoms may influence various underlying pathophysiological factors and modulate the inflammatory response and course of illness, affecting treatment planning.Disclosure of interestThe authors have not supplied their declaration of competing interest.


2011 ◽  
Vol 26 (S2) ◽  
pp. 619-619 ◽  
Author(s):  
E. Corruble ◽  
C. Bélaidi ◽  
G.M. Goodwin

The novel antidepressant agomelatine is a MT1/MT2 receptor agonist and a 5HT2c receptor antagonist, whose efficacy is demonstrated in Major Depressive Disorder (MDD) (1). In an international 24-week double-blind randomized controlled study, the effects of agomelatine 25–50 mg/d (n = 164) were compared to those of escitalopram 10-20 mg/d (n = 160) on satisfaction about sleep (Visual Analogic Scale), depressive symptoms (Hamilton Depression Rating Scale (HAM-D)) and emotions in a subset of 45 patients having completed the Oxford Depression Questionnaire (2).Both drugs improved depressive symptoms (mean decrease in HAM-D score from baseline: -19.9 with agomelatine and -19.2 with escitalopram; percentage of remitters: 69.6% with agomelatine and 63.1% with escitalopram, LOCF endpoint) and the satisfaction about sleep. Interestingly, the wellness feeling on waking was more improved with agomelatine as compared to escitalopram (p = 0.025), indicating a better alertness on waking with agomelatine than escitalopram.Moreover, emotional blunting was less frequent with agomelatine as compared to escitalopram: 28% on agomelatine vs 60% on escitalopram felt that their emotions lacked intensity with a trend to statistical significance (p = 0.063) and 16% of patients on agomelatine vs 53% on escitalopram felt that things that they cared about before illness did not seem important any more (p = 0.024). Finally, less patients withdrew due to emergent adverse events with agomelatine (4.3%) as compared to escitalopram (10.6%), (p = 0.029). To conclude, this study shows some potential clinical advantages of agomelatine as compared to escitalopram in the long term treatment of MDD.


2018 ◽  
Author(s):  
Archana Sarda ◽  
Suresh Munuswamy ◽  
Shubhankar Sarda ◽  
Vinod Subramanian

BACKGROUND Research studies are establishing the use of smartphone sensing to measure mental well-being. Smartphone sensor information captures behavioral patterns, and its analysis helps reveal well-being changes. Depression in diabetes goes highly underdiagnosed and underreported. The comorbidity has been associated with increased mortality and worse clinical outcomes, including poor glycemic control and self-management. Clinical-only intervention has been found to have a very modest effect on diabetes management among people with depression. Smartphone technologies could play a significant role in complementing comorbid care. OBJECTIVE This study aimed to analyze the association between smartphone-sensing parameters and symptoms of depression and to explore an approach to risk-stratify people with diabetes. METHODS A cross-sectional observational study (Project SHADO—Analyzing Social and Health Attributes through Daily Digital Observation) was conducted on 47 participants with diabetes. The study’s smartphone-sensing app passively collected data regarding activity, mobility, sleep, and communication from each participant. Self-reported symptoms of depression using a validated Patient Health Questionnaire-9 (PHQ-9) were collected once every 2 weeks from all participants. A descriptive analysis was performed to understand the representation of the participants. A univariate analysis was performed on each derived sensing variable to compare behavioral changes between depression states—those with self-reported major depression (PHQ-9>9) and those with none (PHQ-9≤9). A classification predictive modeling, using supervised machine-learning methods, was explored using derived sensing variables as input to construct and compare classifiers that could risk-stratify people with diabetes based on symptoms of depression. RESULTS A noticeably high prevalence of self-reported depression (30 out of 47 participants, 63%) was found among the participants. Between depression states, a significant difference was found for average activity rates (daytime) between participant-day instances with symptoms of major depression (mean 16.06 [SD 14.90]) and those with none (mean 18.79 [SD 16.72]), P=.005. For average number of people called (calls made and received), a significant difference was found between participant-day instances with symptoms of major depression (mean 5.08 [SD 3.83]) and those with none (mean 8.59 [SD 7.05]), P<.001. These results suggest that participants with diabetes and symptoms of major depression exhibited lower activity through the day and maintained contact with fewer people. Using all the derived sensing variables, the extreme gradient boosting machine-learning classifier provided the best performance with an average cross-validation accuracy of 79.07% (95% CI 74%-84%) and test accuracy of 81.05% to classify symptoms of depression. CONCLUSIONS Participants with diabetes and self-reported symptoms of major depression were observed to show lower levels of social contact and lower activity levels during the day. Although findings must be reproduced in a broader randomized controlled study, this study shows promise in the use of predictive modeling for early detection of symptoms of depression in people with diabetes using smartphone-sensing information.


1995 ◽  
Vol 7 (S1) ◽  
pp. 27-39 ◽  
Author(s):  
Charles F. Reynolds III ◽  
Ellen Frank ◽  
James M. Perel ◽  
Sati Mazumdar ◽  
David J. Kupfer

Major depression in the elderly is often a relapsing, chronic illness with high risk for chronic invalidism, poor treatment compliance, and suicide. In most cases, maintenance treatment to prevent recurrence and to enhance the quality of life is thought to be indicated. We review recent data from our onging studies that support both the efficacy and the safety of pharmacotherapeutic and psychotherapeutic maintenance treatments. However, the challenges of conducting maintenance therapy research (particularly with a placebo control) with the elderly are many, involving such areas as recruitment, retention, compliance, choice of outcome measures, and informed consent. We discuss each of these challenges and our responses to them. Finally, we suggest that maintenance therapy trials should be extended in several directions: (a) long-term treatment of bipolar and delusional subtypes in the elderly, as well as depression associated with progressive neurodegenerative disorders such as Alzheimer's dementia; (b) assessment of the benefits and risks of long-term therapy with other than tricyclic and monoamine oxidase inhibitor antidepressant agents, such as selective serotonin reuptake inhibitors; and (c) development of models of long-term course, including the interaction of treatments with medical and psychosocial variables that can have a profound impact on illness onset and offset. These issues are illustrated with a discussion of a new protocol designed to test the acute and maintenance efficacy of antidepressant therapy for depressed patients with Alzheimer's disease.


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