scholarly journals Augmentation Strategies for Patients with Major Depressive Disorder with an Inadequate Response to Antidepressant Monotherapy

2014 ◽  
Vol 60 (2) ◽  
pp. 61-66
Author(s):  
Th Moica ◽  
I Gabos Grecu ◽  
Marieta Gabos Grecu ◽  
Melinda Ferencz ◽  
Elena Gabriela Buicu ◽  
...  

Abstract Introduction: Major depressive disorder is a chronic and debilitating disease characterized by a wide range of emotional and physical symptoms that coexist during a depressive episode and may reoccur at some point during the progression of the disease for the majority of patients. The purpose of the study was to investigate psychiatrists’ experience regarding the response to antidepressive treatment and their options regarding augmentation strategies in depression with incomplete response to antidepressant monotherapy. Method: We applied an 18-item questionnaire containing multiple choice questions to adult psychiatrists working in ambulatories, hospitals or mental health centers. Results: Fourty-two psychiatrists have agreed to answer the questionnaire. The majority of them were psychiatry specialists, between 35 and 49 years of age, working in an outpatient unit. For the majority of doctors, SSRIs (Serotonin Reuptake Inhibitors) proved to be the first line treatment both for the first depressive episode and for recurrent depression, followed by SNRI (Serotonin and Noradrenalin Reuptake Inhibitors). Regarding the duration of maintenance treatment for the patients who achieved complete remission after the first episode of depression, the results showed a wide spectrum from 4 to 9 months. Conclusions: Incomplete response to antidepressive monotherapy is very frequent both for the first depressive episode and for recurrent depression. Given the pharmacological profile that some atypical antipsychotic have, augmentation with atypical antipsychotics in patients with inadequate response to antidepressant monotherapy is a useful therapeutic strategy that should be considered.

2017 ◽  
Vol 41 (S1) ◽  
pp. S510-S510
Author(s):  
K. Yoshimasu ◽  
S. Takemura ◽  
E. Myasoedova ◽  
S. Myasoedova

IntroductionDrinking has been shown to be a protective factor against the risk of rheumatoid arthritis (RA). On the other hand, high prevalence of depressive symptoms has been observed among RA patients.ObjectiveTo evaluate the association between depressive symptoms and somatic factors as well as drinking habits in RA patients.MethodsDrinking habits and physical symptoms in 182 female RA outpatients in Ivanovo, Russia (average [standard deviation] of age, 62.0 [11.7] years), were investigated. Drinking status was classified as current drinkers (alcohol consumption within the previous 12 months) and others. Depressive symptoms were evaluated with MINI, HADS and CES-D questionnaires. Outcomes were (a) presence or history of major depressive disorder, presence of melancholic major depressive disorder, presence of dysthymia, or 1 point or greater of suicidal risk score in MINI, (b) 8 points or greater in HADS-depression, (c) 8 points or greater in HADS-anxiety, and (d) 16 points or greater in CES-D. Stepwise logistic regression was used to evaluate somatic factors associated with depressive symptoms, with age and drinking status included.ResultsDrinking was rather protective against depression, but did not reach statistical significance. Symptomatic parts in the extremities associated with the outcomes were shoulders for MINI, elbows and knees for HADS-depression, shoulders for HADS-anxiety, and hands, elbows and shoulders for CES-D. In the stepwise selection, some symptoms in the extremities were positively associated with the outcomes.ConclusionSymptoms chiefly in large joints contributed to depressive symptoms.Disclosure of interestThe authors have not supplied their declaration of competing interest.


2017 ◽  
Vol 92 ◽  
pp. 119-123 ◽  
Author(s):  
Fernanda Pedrotti Moreira ◽  
Karen Jansen ◽  
Taiane de Azevedo Cardoso ◽  
Thaíse Campos Mondin ◽  
Pedro Vieira da Silva Magalhães ◽  
...  

CNS Spectrums ◽  
2014 ◽  
Vol 20 (2) ◽  
pp. 148-156 ◽  
Author(s):  
Stuart A. Montgomery ◽  
Carl P. Gommoll ◽  
Changzheng Chen ◽  
William M. Greenberg

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.


2016 ◽  
Vol 33 (S1) ◽  
pp. S407-S407
Author(s):  
S. Bise ◽  
B. Kurtovic ◽  
D. Begic ◽  
O. Cemalovic

Augmentation strategies for the treatment of Major depressive disorder (MDD) are needed when patients with MDD have a partial, or not responded to antidepressant monotherapy. The focus of augmentation therapy has been combining an antidepressant (AD) medication with another AD. Atypical antipsychotics (AAP) are becoming commonly used to augment antidepressants. Beyond AD and AAP, alternative augmentation strategies include mood stabilizers (MS).AimTo analyze the characteristics of therapy in patients with diagnosis of MDD and to investigate the frequency of augmentation therapy.MethodStudy included 28 patients hospitalized during one year with MDD diagnosis. Statistical analysis was performed with x2 and t-test.ResultAmong patients with MDD there were 18 (64.28%) women with an average age 57.5 and 10 (35.71%) men with an average age 53.5. Of the 28 patients with MDD, 25 (89.28%) were treated with a combination therapy, and monotherapy in the remaining 3 patients (10.71%). Of 25 patients with augmentation strategy treatment, 22 (88%) used two medications and the remaining 3 (12%) tree psychotropic medications (AAP, AD, MS). The most frequent combinations were a combination of AD and AAP (17 patients, 68%). Beyond that frequent combination were AD and MS (6 patients, 24%). Two patients used combination two AAP, and one patient with two AD and one patients used AAP and MS.ConclusionAugmentation strategy is often used in patients with MDD. There is no significant difference in the use combination therapy based on gender and age.Disclosure of interestThe authors have not supplied their declaration of competing interest.


2018 ◽  
Vol 31 (1) ◽  
pp. 27-35 ◽  
Author(s):  
Michael Bauer ◽  
Nanco Hefting ◽  
Annika Lindsten ◽  
Mette Krog Josiassen ◽  
Mary Hobart

AbstractObjectiveTo evaluate brexpiprazole adjunctive to antidepressant therapies (ADTs) as maintenance treatment in patients with major depressive disorder with inadequate response to ADT, utilising a novel study design.MethodsThe study comprised an 8-week prospective treatment period with open-label ADT with double-blind placebo treatment and a 24-week randomised treatment period. Investigators and patients were blinded to treatment periods, randomisation criteria, and timing of randomisation. Patients with early response to open-label ADT were withdrawn at Week 6. Patients fulfilling criteria for inadequate response were randomised to ADT+brexpiprazole 1–3 mg/day, or ADT+placebo. The primary endpoint was full remission: Montgomery–Åsberg Depression Rating Scale (MADRS) total score ≤10 and ≥50% decrease from randomisation (i.e. baseline) in MADRS total score for at least 8 consecutive weeks.ResultsThe primary efficacy analysis failed to show a statistically significant difference between the proportions of patients on ADT+brexpiprazole (21.4%) and ADT+placebo (24.9%) achieving full remission; odds ratio: 0.83; p=0.2641. The secondary endpoint of change from baseline to Week 6 in MADRS total score showed no difference between ADT+brexpiprazole and ADT+placebo (−0.4; p=0.3259). The most frequent treatment-emergent adverse event (TEAE) in patients receiving ADT+brexpiprazole was weight increased (9.5% vs. 5.0% in ADT+placebo). The incidence of TEAEs leading to withdrawal in the randomised treatment period was 6.3% in the ADT+brexpiprazole group and 3.4% in the ADT+placebo group.ConclusionAdjunctive brexpiprazole did not differentiate from ADT+placebo on the primary endpoint of full remission. A number of design elements in this previously untried study design may have contributed to the study result. Brexpiprazole was well tolerated.


CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 314-315
Author(s):  
Maurizio Fava ◽  
Bryan Dirks ◽  
Marlene P. Freeman ◽  
Richard C. Shelton ◽  
Michael E. Thase ◽  
...  

Abstract:Study Objectives:Depression is the leading cause of disability worldwide, with fewer than 50% of treated patients achieving full remission. This study (“CLARITY,” ACP-103-042: NCT03018340) examined the 5-HT2A inverse agonist pimavanserin (PIM) as a potential adjunctive treatment for major depressive disorder (MDD).Method:Adult female and male subjects with a DSM-5 primary diagnosis of a major depressive episode as part of MDD, inadequate response to ongoing SSRIs or SNRIs of adequate dose and duration as confirmed by the Massachusetts General Hospital Antidepressant Treatment History Questionnaire, and a MADRS total score >20 were randomized to PIM 34 mg/day or placebo (PBO) added to their SSRI/SNRI treatment. A sequential parallel comparison design was used, consisting of two 5-week stages. PBO nonresponders in Stage-1 who met prespecified criteria were re-randomized to PIM or PBO for the second period (Stage-2). The primary efficacy measure was the weighted average of Stage-1 and Stage-2 total scores of the HAMD-17.Results:Of the 207 patients enrolled, 52 received PIM, and 155 received PBO in Stage 1. Mean age was 46.2 years, and 72.9% of patients were female. Baseline MADRS total (mean [SD]: 31.5 [0.4]) and HAMD-17 total scores (22.2 [0.3]) indicated a moderate overall severity of illness. PIM met the primary endpoint, reducing the weighted Stage-1/Stage-2 HAMD-17 total score relative to PBO (least-square means [LSM] difference, –1.7; standard error [SE], 0.9; P=0.04). Stage-1 PIM patients demonstrated highly significant 5-week improvement on the HAMD-17 (LSM difference=–4.0, SE=1.1; P<0.001; effect size, Cohen’s d: 0.626), separating from placebo by the end of Week 1 (LSM difference=–1.7, SE=0.8; P=0.04). Stage-2 results showed no significant separation among Stage-1 placebo nonresponders (P=0.69). In Stage 2, a substantively smaller number of subjects (n=58) were rerandomized than planned, likely due to restrictive criteria for re-randomization. Greater overall improvement was seen with PIM relative to PBO on the key secondary endpoint, the Sheehan Disability Scale (LSM difference=–0.8, SE=0.3; P=0.004), and positive results were also seen on 7 of the 11 other secondary endpoints, including responder rate (≥50% reduction in HAMD-17 total; P=0.007), Massachusetts General Hospital Sexual Functioning Index (P<0.001), and Karolinska Sleepiness Scale for daytime sleepiness (P=0.02). Discontinuations due to adverse events were low (PIM 1.2%, PBO 3.2%). One serious adverse event was reported in each treatment group, deemed unrelated to treatment. No deaths were reported. Laboratory assessments, electrocardiography, and changes in vital signs were unremarkable, and no new safety signals were reported.Conclusions:Study data provide evidence of the efficacy, safety, and tolerability of adjunctive PIM in treating MDD inadequately responsive to SSRI or SNRI therapy. Efforts to confirm these results are ongoing in a Phase 3 program.Funding Acknowledgements:ACADIA Pharmaceuticals Inc.


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