Efficacy and safety of selegiline transdermal system (STS) for the atypical subtype of major depressive disorder: pooled analysis of 5 short-term, placebo-controlled trials

CNS Spectrums ◽  
2013 ◽  
Vol 19 (4) ◽  
pp. 324-329 ◽  
Author(s):  
Chi-Un Pae ◽  
Ashwin A. Patkar ◽  
Saeheon Jang ◽  
Kimberly B. Portland ◽  
Sungwon Jung ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Remission Rate ◽  
Pooled Analysis ◽  
Comparable Efficacy ◽  
Efficacy And Safety ◽  
Short Term ◽  
Major Depressive ◽  
Definition Of

ObjectiveThe objective of the present study is to investigate the efficacy and safety of the selegiline transdermal system (STS) in major depressive disorder (MDD) with atypical features.MethodsThis was a post-hoc analysis of 5 short-term trials. The atypical subtype was defined as the presence of at least 1 item with a score of 2 or greater from items 22–26 on the 28-item Hamilton Depression Rating Scale (HAMD-28), and a maximum score of 1 point for items 6 (insomnia late), 12 (somatic symptoms, gastrointestinal), and 16 (loss of weight) to exclude vegetative features of melancholic depression. The mean changes of HAMD-28 total score from baseline to the endpoint (response rate defined as ≥50% reduction in HAMD-28 scores and remission rate defined as ≤10 HAMD-28 total score at the treatment endpoint) were compared between atypical and nonatypical groups.ResultsIn this analysis, 352 subjects (STS = 168 vs placebo = 184) met the definition of atypical subtype at baseline. STS (n = 641) significantly decreased HAMD-28 total score compared with placebo (n = 648) from beginning to end of treatment (–10.7 ± 9.3 vs –9.4 ± 9.3; p = 0.014). STS showed comparable efficacy in patients with the atypical subtype compared with the nonatypical subtype for placebo-subtracted mean change in HAMD-28 total score (–2.11 ± 1.01 vs. –1.0 ± 0.60; p = 0.34), odds ratio (OR) for response (1.41 vs 1.23, p = 0.62), and OR for remission (1.77 vs 1.18, p = 0.22).ConclusionSTS appears to be comparably efficacious and tolerable in atypical and nonatypical subtypes of MDD. Adequately powered, controlled, clinical trials are necessary to confirm our findings.

scholarly journals Efficacy of levomilnacipran extended-release in major depressive disorder: pooled analysis of 5 double-blind, placebo-controlled trials

CNS Spectrums ◽  
2014 ◽  
Vol 20 (2) ◽  
pp. 148-156 ◽  
Author(s):  
Stuart A. Montgomery ◽  
Carl P. Gommoll ◽  
Changzheng Chen ◽  
William M. Greenberg
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Extended Release ◽  
Rating Scale ◽  
Pooled Analysis ◽  
Major Depressive ◽  
Double Blind ◽  
Madrs Score ◽  
Wide Range ◽  
Remission Rates

Introduction/ObjectivePost hoc analyses were conducted to evaluate the efficacy of levomilnacipran extended-release (ER) in subgroups of patients with major depressive disorder (MDD).MethodsData were pooled from 5 completed Phase II/III studies. Patients were categorized by sex, age, MDD duration, recurrence of MDD, current episode duration, number of prior episodes, and baseline Montgomery–Åsberg Depression Rating Scale (MADRS) score. Efficacy was evaluated by MADRS least squares (LS) mean change from baseline, response (MADRS improvement ≥50%), and remission (MADRS ≤10).ResultsIn the pooled population, treatment with levomilnacipran ER versus placebo resulted in greater improvement in MADRS score (−15.8 versus −12.9; LS mean difference, −2.9; P < .001) and higher response rates (44.7% versus 34.5%; P < .001). Comparable treatment effects were found in most subgroups. Remission rates in the overall population were higher for levomilnacipran ER versus placebo (27.7% versus 21.5%; P < .05); notably high remission rates were seen in patients with baseline MADRS score < 30 (48.8% versus 28.9%; P < .001).DiscussionClinically meaningful improvements in depressive symptoms were found across subgroups, including statistically significant outcomes for both response and remission.ConclusionLevomilnacipran ER was efficacious across a wide range of MDD patients, including men and women, ages 18–78, with varying histories and symptom severity.

scholarly journals 50 Adjunctive Buprenorphine/Samidorphan Combination in Patients with Major Depressive Disorder: Phase 3 Long-term Extension Study Results

CNS Spectrums ◽  
2019 ◽  
Vol 24 (1) ◽  
pp. 203-204 ◽  
Author(s):  
Michael Thase ◽  
Arielle D. Stanford ◽  
Asli Memisoglu ◽  
William Martin ◽  
Amy Claxton ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Safety Profile ◽  
Rating Scale ◽  
Remission Rate ◽  
Term Treatment ◽  
Adjunctive Treatment ◽  
Major Depressive ◽  
Long Term Treatment

AbstractIntroductionBuprenorphine/samidorphan (BUP/SAM), a combination of BUP (a µ-opioid receptor partial agonist and κ-antagonist) and SAM (a sublingually bioavailable µ-opioid antagonist), is an investigational opioid system modulator for depression. BUP/SAM has shown efficacy versus placebo as an adjunctive treatment for major depressive disorder (MDD) and a consistent safety profile in previously reported, placebo-controlled clinical studies.1,2Study Objective(s)1. To characterize the safety profile following long-term treatment with BUP/SAM2. To explore depression symptoms and remission rates in patients with MDD following long-term treatment with BUP/SAMMethodsFORWARD-2 (Clinicaltrials.gov ID: NCT02141399) enrolled patients who had participated in 1 of 4 controlled studies as well as de novo patients. All patients had a confirmed diagnosis of MDD, had a history of inadequate response to standard antidepressant therapies (ADTs), and had been treated with an adequate dose of an established ADT for ≥8weeks before BUP/SAM initiation. ADT dosage could be titrated, but the ADT could not be changed. During the study, patients received open-label, sublingual BUP/SAM 2mg/2mg as adjunctive treatment for up to 52weeks. Safety (primary objective) was assessed via adverse events (AEs), vital signs, laboratory analytes, and electrocardiography. Suicidal ideation or behavior (SIB) was evaluated by the Columbia Suicide Severity Rating Scale. Abuse potential, dependence, and withdrawal were assessed by AEs and the Clinical Opiate Withdrawal Scale. Exploratory efficacy endpoints included mean Montgomery–Åsberg Depression Rating Scale (MADRS) scores and remission rate (MADRS ≤10).ResultsOf 1454 total patients, 49% completed the 52-week study, 11% discontinued due to an AE, and 40% discontinued because of other reasons as of the interim data cutoff date (April 30, 2017). Most AEs were of mild/moderate severity. Serious AEs were reported in 3.2% of patients. AEs occurring in ≥10% of patients were nausea, headache, constipation, dizziness, and somnolence. There was no evidence of increased risk of SIB with BUP/SAM. Incidence of euphoria-related events was low (1.2%). After abrupt discontinuation of BUP/SAM, there was little evidence of withdrawal. BUP/SAM was not associated with meaningful changes in laboratory or metabolic parameters or in bodyweight. The mean MADRS score decreased from 22.9 (±9.7) at baseline to 9.8 (±8.8) after 52weeks. The remission rate at 52weeks was 52.5%.ConclusionsLong-term treatment with BUP/SAM did not reveal any new safety findings and confirmed that the risk of abuse and dependence with BUP/SAM was low. BUP/SAM maintained an antidepressant effect for up to 52weeks of treatment in patients with MDD.Funding Acknowledgements: Alkermes, Inc.

scholarly journals Measures of suicidality in phase 3 clinical trials of levomilnacipran ER in adults with major depressive disorder

CNS Spectrums ◽  
2017 ◽  
Vol 22 (6) ◽  
pp. 475-483 ◽  
Author(s):  
Michael E. Thase ◽  
Carl Gommoll ◽  
Changzheng Chen ◽  
Kenneth Kramer ◽  
Arif Khan ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Suicidal Ideation ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Short Term ◽  
Open Label ◽  
Major Depressive ◽  
Double Blind ◽  
And Behavior

ObjectiveTo evaluate the effects of levomilnacipran extended-release (ER) on suicidal ideation and behavior in adults with major depressive disorder (MDD).MethodsPost hoc analyses were conducted in patients from 4 randomized, double-blind, placebo-controlled trials and a long-term, open-label extension study of levomilnacipran ER (40-120 mg/d) in adults with MDD. Analyses included incidence of suicide-related treatment-emergent adverse events (TEAEs); incidence of Columbia–Suicide Severity Rating Scale (C-SSRS) suicidal ideation (score=1–5) and behavior (score=6-10); percent of patients who shifted from no C-SSRS suicidal ideation/behavior at baseline to suicidal ideation during treatment (worsened from score=0 to score=1–5), or vice-versa (improved from score=1-5 to score=0).ResultsSuicide-related TEAEs occurred in<1% of patients in the levomilnacipran ER studies. The incidence of C-SSRS suicidal ideation was 22.2%, 23.9%, and 21.7% for placebo, short-term levomilnacipran ER, and long-term levomilnacipran ER, respectively; C-SSRS suicidal behavior was<1% in all of these groups. In the short-term studies, the percentage of patients with C-SSRS shifts were as follows: worsening from score=0 to score=1–5 (placebo, 8.6%; levomilnacipran ER, 11.0%); improvement from score=1–5 to score=0 (placebo, 24.0%; levomilnacipran ER, 27.7%).ConclusionIn adult MDD patients, the incidence of suicidal ideation and behavior was similar between placebo and short-term levomilnacipran ER as indicated by TEAE reports and C-SSRS scores. Worsening in C-SSRS scores was also similar between placebo and levomilnacipran ER. There was no indication of increased suicidality during longer courses of continued therapy. Together, these findings suggest that this medication is not associated with increased risks of suicidal ideation or behavior.

scholarly journals The efficacy and safety of Anyu Peibo Capsule in the treatment of patients with major depressive disorder in China: study protocol for a randomized placebo-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jingjing Huang ◽  
Yimin Yu ◽  
Yi Jiang ◽  
Wu Chen ◽  
Yan Li ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Controlled Trial ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Phase Ii Trials ◽  
Major Depressive ◽  
Link Type ◽  
Double Blinded

Abstract Background Major depressive disorder is the second leading cause of years lost to disability worldwide. Anyu Peibo Capsule has been shown to be effective and safe in phase II trials. Methods This clinical study is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group, phase III trial of Anyu Peibo Capsule in China. The aim is to test whether the administration of Anyu Peibo Capsule compared to placebo improves clinical outcomes in adults (aged 18 to 65 years) with MDD. Patients will receive an 8-week treatment of Anyu Peibo Capsule 1.6 g per day or placebo. The primary outcome will be the change from baseline in the total score for the Montgomery-Asberg Depression Rating Scale at the end of the 8-week treatment. Discussion The trial aims to provide pivotal evidence for the efficacy and safety of Anyu Peibo Capsule in patients with major depressive disorder. Trial registration ClinicalTrials.govNCT04210973. Registered on December 26, 2019

scholarly journals Efficacy and safety of brexpiprazole as adjunctive treatment in major depressive disorder: overview of four short-term studies

2019 ◽  
Vol 20 (15) ◽  
pp. 1907-1916 ◽  
Author(s):  
Michael E Thase ◽  
Peter Zhang ◽  
Catherine Weiss ◽  
Stine Rasmussen Meehan ◽  
Mary Hobart
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Adjunctive Treatment ◽  
Efficacy And Safety ◽  
Short Term ◽  
Major Depressive

Vortioxetine versus citalopram in treating major depressive disorder (MDD)

2017 ◽  
Vol 41 (S1) ◽  
pp. S540-S541
Author(s):  
A. Rossi ◽  
E. Di Tullio ◽  
P. Prosperini ◽  
A. Feggi ◽  
C. Gramaglia ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Adverse Events ◽  
Depressive Disorder ◽  
Cognitive Performance ◽  
Cognitive Dysfunction ◽  
Rating Scale ◽  
Verbal Learning ◽  
Social Impairment ◽  
Efficacy And Safety ◽  
Major Depressive

IntroductionCitalopram is a widely used antidepressant (AD), indicated for the treatment of Major Depressive Disorder (MDD), with a high and Selective Serotonin Reuptake Inhibitory action (SSRI), good efficacy and safety profile. Vortioxetine is a novel multimodal antidepressant compound, with a mixed action on Serotonin (both 5-HT agonism and antagonism). Its clinical efficacy has been established in several short and long term trials; furthermore it proved effective at mitigating cognitive dysfunction, which is addressed to as one of the main causes of social impairment in MMD patients.ObjectivesTo evaluate the relative efficacy and safety of Vortioxetine versus Citalopram, in patients suffering from MDD.AimsTo assess whether Vortioxetine effectiveness and tolerability are comparable to those observed for previous antidepressants.MethodsThe main outcomes were efficacy (variance from baseline to 1 month) in the Montgomery-Åsberg Depression Rating Scale (MADRS) and Hamilton Rating Scale for Depression (HAM-D) and tolerability (adverse events). Changes in cognitive performance were assessed using the following specifics tools: Digit symbol substitution test (DSST), Trail Making Test A (TMT-A) and Hopkins Verbal Learning Test-Revised (HVLT-R).ResultsData collection is ongoing. According to Literature we expect to find a significant number of MDD patients on Vortioxetine to achieve a reduction in depressive symptoms from baseline, to report poor adverse events and to increase their cognitive performance.ConclusionAs shown by recent literature, Vortioxetine might be an effective option in treating MMD with particular focus on cognitive dysfunction.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Effects of desvenlafaxine versus placebo on MDD symptom clusters: A pooled analysis

2020 ◽  
Vol 34 (3) ◽  
pp. 280-292 ◽  
Author(s):  
Martin A Katzman ◽  
Xuemei Wang ◽  
Dalia B Wajsbrot ◽  
Matthieu Boucher
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Pooled Analysis ◽  
Symptom Clusters ◽  
Analysis Of Covariance ◽  
Major Depressive ◽  
Double Blind ◽  
Early Improvement ◽  
Hamilton Rating Scale

Background: Major depressive disorder is characterized by the presence of at least five of nine specific symptoms that contribute to clinically significant functional impairment. This analysis examined the effect of desvenlafaxine (50 or 100 mg) versus placebo on symptom cluster scores and the association between early improvement in symptom clusters and symptomatic or functional remission at week 8. Methods: Using data from nine double-blind, placebo-controlled studies of desvenlafaxine for the treatment of major depressive disorder ( N=4317), the effect of desvenlafaxine 50 or 100 mg versus placebo on scores for symptom clusters based on 17-item Hamilton Rating Scale for Depression items was assessed using analysis of covariance. Association between early improvement in symptom clusters (⩾20% improvement from baseline at week 2) and symptomatic and functional remission (17-item Hamilton Rating Scale for Depression total score ⩽7; Sheehan Disability Scale score <7) at week 8 was analyzed using logistic regression. Symptom clusters based on Montgomery–Åsberg Depression Rating Scale were also examined. Results: Desvenlafaxine 50 or 100 mg was associated with significant improvement from baseline compared to placebo for all symptom clusters ( p<0.001), except a sleep cluster for desvenlafaxine 100 mg. For all symptom clusters, early improvement was significantly associated with achievement of symptomatic and functional remission at week 8 for all treatment groups ( p⩽0.0254). Conclusion: Early improvement in symptom clusters significantly predicts symptomatic or functional remission at week 8 in patients with depression receiving desvenlafaxine (50 or 100 mg) or placebo. Importantly, patients without early improvement were less likely to remit.

Sign in / Sign up

Export Citation Format

Share Document