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.

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.

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.

scholarly journals Effects of Celecoxib on Electroconvulsive Therapy-Induced Cognitive Impairment in Patients With Major Depressive Disorder: A Pilot, Double-Blind, Placebo-Controlled Trial

2020 ◽  
Author(s):  
Nafiseh Banaha ◽  
Padideh Ghaeli ◽  
Abolghasem Yousefi ◽  
Valentin Artounian ◽  
Mohammad H. Afzali ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Cognitive Impairment ◽  
Depressive Disorder ◽  
Electroconvulsive Therapy ◽  
Rating Scale ◽  
Color Test ◽  
Major Depressive ◽  
Double Blind ◽  
Cox 2 ◽  
Hamilton Rating Scale

Cognitive impairment, an important side effect of electroconvulsive therapy (ECT), may be related to the release of prostaglandins in the brain. Cyclooxygenase-2 (COX-2), constitutively expressed in the CNS, has a functional role in glutamate-mediated learning and memory. The goal of this pilot, double-blind, placebocontrolled trial was to evaluate the effects of the selective COX-2 inhibitor celecoxib on the adverse cognitive effects of ECT. Twenty patients diagnosed with the major depressive disorder for which ECT was indicated as a treatment for their current episode randomly received either celecoxib (200 mg orally twice a day, a total dose of 400 mg/day) or placebo. All patients underwent the same protocol for anesthesia and ECT procedures. The patients received celecoxib or the placebo for the whole period of ECT treatment, starting the day before ECT and continuing until the sixth (last) session of ECT. The Wechsler Mental Scale-III (WMS-III), the Mini-Mental Scale Examination (MMSE), and Stroop Color test were used to assess cognition before the first session and after the first, third and sixth sessions of ECT. Hamilton rating scale for depression was also used for the assessment of depression before and after the trial. Our data showed that celecoxib group did not have significant improvement in cognition based on WMS-III or MMSE scores. There was an improvement in the Stroop Color test but not statistically significant. Our results demonstrated that although celecoxib was well tolerated in patients undergoing ECT, it did not improve related cognitive impairment. Clinical trial registration number: IRCT201201247202N2. CNS, central nervous system; COX-2, Cyclooxygenase-2; DSM-IV-TR, Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision; ECT, electroconvulsive therapy; ECS, electroconvulsive shocks; HAM-D, Hamilton rating scale for depression; LTP, long term potentiation; MDD, major depressive disorder; MMSE, Mini-Mental State Examination; NSAIDs, nonsteroidal anti-inflammatory drugs; WMS-III, Wechsler Memory Scale-III.

Analysis of the Effect of Desvenlafaxine on Anxiety Symptoms Associated with Major Depressive Disorder: Pooled Data from 9 Short-Term, Double-blind, Placebo-Controlled Trials

CNS Spectrums ◽  
2010 ◽  
Vol 15 (3) ◽  
pp. 187-193 ◽  
Author(s):  
Karen A. Tourian ◽  
Qin Jiang ◽  
Philip T. Ninan
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Anxiety Symptoms ◽  
Anxiety Scale ◽  
Analysis Of Covariance ◽  
Fixed Dose ◽  
Major Depressive ◽  
Double Blind ◽  
Data Set

ABSTRACTBackground: This analysis evaluated the effects of the serotonin-norepinephrine reuptake inhibitor, desvenlafaxine (administered as desvenlafaxine succinate), on anxiety symptoms associated with depression.Methods: Data were pooled from 9 randomized, placebo-controlled, double-blind, 8 week studies of desvenlafaxine (50-400 mg/day, fixed or flexible dose) in patients with major depressive disorder (MDD), without a primary anxiety diagnosis. Changes from baseline in scores on the anxiety/somatization factor of the 17-item Hamilton Rating Scale for Depression (HAM-D17) and on the Covi Anxiety Scale at the final evaluation (last observation carried forward) were compared between desvenlafaxine and placebo groups using analysis of covariance.Results: In the overall data set (intent to treat n=2,913 [desvenlafaxine, n=1,805; placebo, n=1,108]), desvenlafaxine was associated with significantly greater reductions compared with placebo in scores on the HAM-D17 anxiety/somatization factor (-3.41 vs -2.92, P<.001) and Covi Anxiety Scale (-1.35 vs -1.04, P<.001). In the subset of fixed-dose studies, significant differences were observed for all dose groups on the HAM-D17 anxiety/somatization factor (P≤.OH), and for the 50, 100, and 200 mg/day dose groups on the Covi Anxiety Scale (all P≤.015 vs placebo).Conclusions: Desvenlafaxine was associated with significantly greater improvement in anxiety symptoms compared with placebo in patients with MDD.

Extended Release Quetiapine Fumarate Monotherapy for Major Depressive Disorder: Results of a Double-Blind, Randomized, Placebo-Controlled Study

CNS Spectrums ◽  
2009 ◽  
Vol 14 (6) ◽  
pp. 299-313 ◽  
Author(s):  
Richard Weisler ◽  
J. Mark Joyce ◽  
Lora McGill ◽  
Arthur Lazarus ◽  
Johan Szamosi ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Extended Release ◽  
Rating Scale ◽  
Controlled Study ◽  
Major Depressive ◽  
Double Blind ◽  
Quetiapine Fumarate ◽  
Quetiapine Xr ◽  
Hamilton Rating Scale

AbstractIntroduction: Once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy was evaluated in major depressive disorder (MDD).Method: This was an 8-week (6-week randomized-phase; 2-week drug-discontinuation/tapering phase), double-blind, parallel-group, placebo-controlled study. The primary outcome measure was Montgomery-Åsberg Depression Rating Scale (MADRS) total score randomization-to-Week 6 change. Other assessments included the Hamilton Rating Scale for Depression, the Hamilton Rating Scale for Anxiety, and adverse events (AEs).Results: 723 patients were randomized: 182, 178, 179, and 184 to quetiapine XR 50, 150, 300 mg/day, and placebo, respectively. At Week 6, significant reductions occurred in MADRS score with quetiapine XR 50 mg/day (−13.56; P<.05), 150 mg/day (−14.50; P<.01) and 300 mg/day (−14.18; P<.01) versus placebo (−11.07); at Day 4, reductions for quetiapine XR (titrated to 50 or 150 mg/day according to dose group) versus placebo (−2.9) were: −4.7 (P<.01), −5.2 (P<.001), and −5.1 (P<.001), respectively. At endpoint, MADRS response (≥50% reduction in score) was 42.7% (P<.01), 51.2% (P<.001), and 44.9% (P≤.001) for quetiapine XR 50, 150, and 300 mg/day, respectively; 30.3% for placebo. Overall, quetiapine XR 150 mg/day provided consistently more positive secondary efficacy results than 50 mg/day and 300 mg/day versus placebo. The most common AEs in quetiapine XR-treated patients were dry mouth, sedation, somnolence, headache, and dizziness.Conclusion: In patients with MDD, quetiapine XR monotherapy (50/150/300 mg/day) is effective in reducing depressive symptoms, with improvement from Day 4 onwards. Safety and tolerability were consistent with the known profile of quetiapine.

Propofol Anaesthesia in Electroconvulsive Therapy

1994 ◽  
Vol 165 (4) ◽  
pp. 506-509 ◽  
Author(s):  
Christopher F. Fear ◽  
Carl S. Littlejohns ◽  
Eryl Rouse ◽  
Paul McQuail
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Electroconvulsive Therapy ◽  
Rating Scale ◽  
Induction Agent ◽  
Double Blind Study ◽  
Major Depressive ◽  
Seizure Duration ◽  
Double Blind ◽  
Induction Agents

BackgroundThe induction agent propofol is known to reduce electroconvulsive therapy (ECT) seizure duration. It is assumed that outcome from depression is adversely affected by this agent. This study compares propofol and methohexitone as induction agents for ECT.MethodIn a prospective, randomised, double-blind study 20 subjects with major depressive disorder (DSM-III-R criteria) received propofol or methohexitone anaesthesia. The Hamilton Depression Rating Scale and Beck Depression Inventory were used to assess depression before therapy, at every third treatment, and at the end of therapy. Seizure duration was measured using the cuff technique.ResultsMean seizure durations (P < 0.01) and mean total seizure duration (P < 0.01) were shorter in the propofol group. There was no difference in outcome.ConclusionsUse of propofol may not adversely affect outcome from depression and it is not necessarily contraindicated as an induction agent for ECT. Our results should be interpreted cautiously, and larger studies are needed.

EEG Synchronized TMS for Individualized Therapy in Major Depressive Disorder

2011 ◽  
Vol 26 (S2) ◽  
pp. 1144-1144
Author(s):  
Y. Jin ◽  
J. Phillips ◽  
Yueqin Huang ◽  
Steven Heurta
Keyword(s):  
Major Depressive Disorder ◽  
Side Effects ◽  
Depressive Disorder ◽  
Active Treatment ◽  
Rating Scale ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Stimulus Frequency ◽  
List Type ◽  
Major Depressive ◽  
Double Blind

IntroductionEfficacy of conventional repetitive transcranial magnetic stimulation (rTMS) in major depressive disorder (MDD) is limited. The authors report here on an alternative treatment using low energy synchronized TMS (sTMS) at the intrinsic frequency of subjects’ alpha electroencephalogram (EEG).ObjectivesEstablish efficacy and safety profile of sTMS in MDD.Aim(1)Examine the clinical effectiveness of sTMS.(2)Identify adverse effects associated with sTMS.MethodsFifty-two MDD subjects with 17-item Hamilton Depression Rating Scale (HAMD17) scores >17 were enrolled into a randomized, sham controlled, double-blind trial. Current medication remained unchanged during the trial. Depressive symptoms were evaluated by HAMD17 administered weekly.EEGs were recorded at baseline to determine the stimulus frequency and at week 4 to evaluate the physiological effect. sTMS was delivered through three 6000-G cylindrical neodymium magnets synchronously rotating at a rate equal to the subject's intrinsic alpha frequency.ResultsForty-five subjects completed at least 1 week of treatment and were evaluable. Those who received active treatment had superior clinical response to sham (t = 2.54, P = 0.01), where 55.2% in the active treatment group were clinical responders versus 12.5% in sham (X2 = 7.82, P = 0.005). No significant side effects were reported. The clinical improvement was correlated with the degree of EEG improvement (r = .46, P = 0.009).ConclusionsA therapeutic effect in MDD subjects can be achieved through administration of sTMS at the subject's alpha EEG frequency. Because of minimal side effects, this appears to be a safe and effective treatment option.

The problematic use of social networking sites associates with elevated symptoms in patients with major depressive disorder

2020 ◽  
Vol 66 (5) ◽  
pp. 496-503 ◽  
Author(s):  
Orkun Aydin ◽  
Fikret Poyraz Çökmüş ◽  
Kuzeymen Balikçi ◽  
Didem Sücüllüoğlu-Dikici ◽  
Pınar Ünal-Aydin
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Symptoms ◽  
Depressive Disorder ◽  
Social Networking ◽  
Rating Scale ◽  
Health Workers ◽  
Well Being ◽  
Social Networking Site ◽  
Analysis Of Covariance ◽  
Major Depressive

Background: Although excessive use of social networking site (SNS) is related to undesired effects on healthy individual’s psychological well-being, there is a huge gap in studies performed with individuals who suffer from various mental disorders. Aim: The main goal of this study is to examine the association between problematic utilization of SNSs and depressive symptoms across patients diagnosed with major depressive disorder (MDD). Methods: 111 patients diagnosed with MDD (diagnoses confirmed via the Structured Clinical Interview for DSM-5–Clinician Version (SCID-5/CV)) and 108 healthy controls (HCs) were recruited for the study. Montgomery–Asberg Depression Rating Scale (MADRS) and Bergen Social Media Addiction Scale (BSMAS) were administered by both MDD and HC groups. Group comparisons were estimated with multivariate analysis of covariance (MANCOVA) analyses. To identify the relationship between SNS addiction and depressive symptoms, the Pearson correlations were performed, and finally, we computed the multiple linear regression analyses to determine whether SNS addiction predicts depressive symptoms. Results: The results revealed that MDD group is more addicted to SNS relative to HC. In addition, depressive symptoms were significantly predicted by ‘relapse’ subdimension and the overall score of SNS addiction in the MDD group. Conclusion: Our study illustrated the detrimental effects of excessive SNSs usage on depressive symptoms in MDD particularly for the individuals in ‘relapse’ state of SNS addiction. The mental health workers should consider the usage patterns of SNSs in patients diagnosed with MDD during their clinical observation and management.

scholarly journals 180 Improvement of Sexual Function Observed During Treatment of Major Depressive Disorder with Adjunctive Pimavanserin

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 313-314
Author(s):  
Marlene P. Freeman ◽  
Maurizio Fava ◽  
Bryan Dirks ◽  
Manish K. Jha ◽  
Richard C. Shelton ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Sexual Function ◽  
Rating Scale ◽  
Sexual Interest ◽  
Massachusetts General Hospital ◽  
Antidepressant Treatment ◽  
Analysis Of Covariance ◽  
Inadequate Response ◽  
Major Depressive

Abstract:Study Objectives:Sexual dysfunction occurs in 40%-60% of patients with major depressive disorder (MDD), due to either the illness itself and/or the effects of antidepressant treatment. The phase-2 CLARITY trial recently demonstrated the efficacy of adjunctive pimavanserin (PIM) for MDD when added to ongoing selective serotonin or serotonin–norepinephrine reuptake inhibitor (SSRI/SNRI) treatment. No new safety observations were reported in this study. This post-hoc analysis examines the potential impact of PIM treatment on sexual function.Method:Study methodology has been presented previously (APA 2019). Adult male and female patients with moderate-to-severe MDD were randomized to PIM 34 mg/day (n=51) or placebo (PBO, n=152) added to ongoing SSRI/SNRI treatment. Massachusetts General Hospital–Sexual Functioning Inventory (MGH-SFI) and Hamilton Depression Rating Scale, 17-item version (HAMD-17) item 14 (sexual interest) scores were examined by analysis of covariance.Results:Adjunctive PIM resulted in significantly greater 5-week reduction (improvement) relative to SSRI/SNRI treatment plus placebo on mean MGH-SFI scores (difference –0.634, SE 0.167; P<0.001; effect size [ES], Cohen’s d 0.614). Similarly, PIM resulted in greater improvement compared with placebo on individual MGH-SFI items that applied to both males and females: Interest in Sex (P=0.006; ES=0.483), Ability to Get Sexually Aroused/Excited (P=0.001; ES=0.560), Ability to Achieve Orgasm (P<0.001; ES=0.609), Overall Sexual Satisfaction (P=0.003; ES=0.524). HAMD-17 item 14 scores were also significantly more reduced (improved) with PIM (P<0.001; ES=0.574).Conclusions:These results underscore the potential of adjunctive PIM for improving sexual function in patients with MDD and inadequate response to SSRIs/SNRIs. Potential benefits should be confirmed in further studies.Funding Acknowledgements:ACADIA Pharmaceuticals Inc.

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