scholarly journals A Randomized, Placebo-Controlled, Active-Reference, Double-Blind, Flexible-Dose Study of the Efficacy of Vortioxetine on Cognitive Function in Major Depressive Disorder

2015 ◽  
Vol 40 (8) ◽  
pp. 2025-2037 ◽  
Author(s):  
Atul R Mahableshwarkar ◽  
John Zajecka ◽  
William Jacobson ◽  
Yinzhong Chen ◽  
Richard SE Keefe
Keyword(s):  
Major Depressive Disorder ◽  
Cognitive Function ◽  
Depressive Disorder ◽  
Path Analysis ◽  
Cognitive Dysfunction ◽  
Digit Symbol Substitution Test ◽  
Major Depressive ◽  
Double Blind ◽  
End Points ◽  
Patient Reported

Abstract This multicenter, randomized, double-blind, placebo-controlled, active-referenced (duloxetine 60 mg), parallel-group study evaluated the short-term efficacy and safety of vortioxetine (10–20 mg) on cognitive function in adults (aged 18–65 years) diagnosed with major depressive disorder (MDD) who self-reported cognitive dysfunction. Efficacy was evaluated using ANCOVA for the change from baseline to week 8 in the digit symbol substitution test (DSST)–number of correct symbols as the prespecified primary end point. The patient-reported perceived deficits questionnaire (PDQ) and physician-assessed clinical global impression (CGI) were analyzed in a prespecified hierarchical testing sequence as key secondary end points. Additional predefined end points included the objective performance-based University of San Diego performance-based skills assessment (UPSA) (ANCOVA) to measure functionality, MADRS (MMRM) to assess efficacy in depression, and a prespecified multiple regression analysis (path analysis) to calculate direct vs indirect effects of vortioxetine on cognitive function. Safety and tolerability were assessed at all visits. Vortioxetine was statistically superior to placebo on the DSST (P<0.05), PDQ (P<0.01), CGI-I (P<0.001), MADRS (P<0.05), and UPSA (P<0.001). Path analysis indicated that vortioxetine’s cognitive benefit was primarily a direct treatment effect rather than due to alleviation of depressive symptoms. Duloxetine was not significantly different from placebo on the DSST or UPSA, but was superior to placebo on the PDQ, CGI-I, and MADRS. Common adverse events (incidence ⩾5%) for vortioxetine were nausea, headache, and diarrhea. In this study of MDD adults who self-reported cognitive dysfunction, vortioxetine significantly improved cognitive function, depression, and functionality and was generally well tolerated.

scholarly journals Cognitive impairment in major depressive disorder

CNS Spectrums ◽  
2018 ◽  
Vol 24 (1) ◽  
pp. 22-29 ◽  
Author(s):  
Zihang Pan ◽  
Caroline Park ◽  
Elisa Brietzke ◽  
Hannah Zuckerman ◽  
Carola Rong ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Cognitive Dysfunction ◽  
Cognitive Deficits ◽  
Functional Disability ◽  
Testable Hypothesis ◽  
Major Depressive ◽  
Cognitive Domains ◽  
Patient Reported ◽  
Neurobiological Substrates

Cognitive dysfunction is a symptomatic domain identified across many mental disorders. Cognitive deficits in individuals with major depressive disorder (MDD) contribute significantly to occupational and functional disability. Notably, cognitive subdomains such as learning and memory, executive functioning, processing speed, and attention and concentration are significantly impaired during, and between, episodes in individuals with MDD. Most antidepressants have not been developed and/or evaluated for their ability to directly and independently ameliorate cognitive deficits. Multiple interacting neurobiological mechanisms (eg, neuroinflammation) are implicated as subserving cognitive deficits in MDD. A testable hypothesis, with preliminary support, posits that improving performance across cognitive domains in individuals with MDD may improve psychosocial function, workplace function, quality of life, and other patient-reported outcomes, independent of effects on core mood symptoms. Herein we aim to (1) provide a rationale for prioritizing cognitive deficits as a therapeutic target, (2) briefly discuss the neurobiological substrates subserving cognitive dysfunction, and (3) provide an update on current and future treatment avenues.

Pain and major depressive disorder: Associations with cognitive impairment as measured by the THINC-integrated tool (THINC-it)

2017 ◽  
Vol 15 (1) ◽  
pp. 62-67 ◽  
Author(s):  
Danielle S. Cha ◽  
Nicole E. Carmona ◽  
Rodrigo B. Mansur ◽  
Yena Lee ◽  
Hyun Jung Park ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Cognitive Function ◽  
Depressive Disorder ◽  
Cognitive Performance ◽  
Cognitive Deficits ◽  
Preliminary Evidence ◽  
Digit Symbol Substitution Test ◽  
Major Depressive ◽  
Subjective Cognitive Function

AbstractObjectivesTo examine the role of pain on cognitive function in adults with major depressive disorder (MDD).MethodsAdults (18–65) with a Diagnostic and Statistical Manual – Fifth Edition (DSM-5)-defined diagnosis of MDD experiencing a current major depressive episode (MDE) were enrolled (nMDD = 100). All subjects with MDD were matched in age, sex, and years of education to healthy controls (HC) (nHC = 100) for comparison. Cognitive function was assessed using the recently validated THINC-integrated tool (THINC-it), which comprises variants of the choice reaction time (i.e., THINC-it: Spotter), One-Back (i.e., THINC-it: Symbol Check), Digit Symbol Substitution Test (i.e., THINC-it: Codebreaker), Trail Making Test – Part B (i.e., THINC-it: Trails), as well as the Perceived Deficits Questionnaire for Depression – 5-item (i.e., THINC-it: PDQ-5-D). A global index of objective cognitive function was computed using objective measures from the THINC-it, while self-rated cognitive deficits were measured using the PDQ-5-D. Pain was measured using a Visual Analogue Scale (VAS). Regression analyses evaluated the role of pain in predicting objective and subjective cognitive function.ResultsA significant between-group differences on the VAS was observed (p < 0.001), with individuals with MDD reporting higher pain severity as evidenced by higher scores on the VAS than HC. Significant interaction effects were observed between self -rated cognitive deficits and pain ratings (p < 0.001) on objective cognitive performance (after adjusting for MADRS total score), suggesting that pain moderates the association between self-rated and objective cognitive function.ConclusionsResults indicated that pain is associated with increased self-rated and objective cognitive deficits in adults with MDD.ImplicationsThe study herein provides preliminary evidence demonstrating that adults with MDD reporting pain symptomatology and poorer subjective cognitive function is predictive of poorer objective cognitive performance. THINC-it is capable of detecting cognitive dysfunction amongst adults with MDD and pain.

scholarly journals Using the Goal Attainment Scale adapted for depression to better understand treatment outcomes in patients with major depressive disorder switching to vortioxetine: a phase 4, single-arm, open-label, multicenter study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Maggie McCue ◽  
Sara Sarkey ◽  
Anna Eramo ◽  
Clement François ◽  
Sagar V. Parikh
Keyword(s):  
Major Depressive Disorder ◽  
Cognitive Function ◽  
Depressive Disorder ◽  
Goal Attainment ◽  
Well Being ◽  
Treatment Goals ◽  
Open Label ◽  
Major Depressive ◽  
Patient Reported ◽  
Goal Attainment Scale

Abstract Background Major depressive disorder (MDD) is the leading cause of disability worldwide. Response to pharmacologic treatment is generally evaluated by traditional clinician- and patient-reported rating scales. Assessing therapeutic efficacy using the Goal Attainment Scale offers a complementary measure that focuses on recovery-oriented outcomes that patients consider valuable and vital to their well-being. This study aimed to examine outcomes using the Goal Attainment Scale adapted for depression (GAS-D). Methods A phase 4, single-arm, open-label, multicenter study enrolled patients with MDD who were switching antidepressant medication. Patients received vortioxetine 10–20 mg over 12 weeks. Three specific, measurable, attainable, relevant, and time-bound goals were collaboratively set by patients with their clinicians. One goal was determined by the patient’s self-defined objectives; 2 were related to predefined domain categories. Prespecified domains included psychological, motivational, emotional, physical/functional, and cognitive categories. The primary endpoint was the proportion of patients who achieved a GAS-D score ≥ 50 at week 12. Secondary and exploratory endpoints included changes from baseline in several clinical and patient-reported measures of depression and cognitive function. Safety and tolerability were also assessed. Results At week 12, of the 122 adults participating in the study, 57.8% achieved a GAS-D score ≥ 50. Depression severity, cognitive function, cognitive performance, well-being, employment, and quality of life also significantly improved. Treatment response and remission rates were 65 and 40%, respectively. Vortioxetine was well tolerated, with adverse events consistent with product labeling. Conclusions A majority of patients with MDD switching to vortioxetine achieved their treatment goals, including improvement in specific functional outcomes relating to physical and emotional goals, as assessed by the GAS-D and standard patient- and clinician-reported measures. When assayed for convergent validity in a separate analysis, changes in goal scores on the GAS-D were statistically significantly correlated with multiple commonly used clinical measures of depression assessed in this study. The GAS-D approach provides a new patient-centric paradigm for the collaborative development and assessment of progress toward meaningful treatment goals, contributing to a comprehensive evaluation of treatment outcomes in patients with MDD. Longer studies against a control intervention are justified. Trial registration ClinicalTrials.gov identifier: NCT02972632. Registered 21 November 2016.

Cognitive dimensions of major depressive disorder

2021 ◽  
pp. 1-8
Author(s):  
Bernhard T. Baune
Keyword(s):  
Major Depressive Disorder ◽  
Cognitive Function ◽  
Depressive Disorder ◽  
Cognitive Dysfunction ◽  
Cognitive Deficits ◽  
Social Cognitive ◽  
Suicide Ideation ◽  
Major Depressive ◽  
Psychosocial Impairment ◽  
Symptomatic Remission

Major depressive disorder is characterized by impaired affect, cognitive dysfunction, and significant psychosocial impairment that persists from weeks to years. Cognitive symptoms are pervasive, affecting functioning in several domains, including reduced executive functioning, attention, memory, learning, psychomotor speed, and verbal processing. Recent evidence suggests that cognitive dysfunction persists following symptomatic remission, highlighting the need to treat cognition separately from mood symptoms. Residual cognitive deficits may contribute to ongoing occupational and social dysfunction and promote suicide ideation. In addition, retention of cognitive impairment may interact with existing emotional and social vulnerability, increasing the risk of recurrent depressive episodes. The chapter characterizes the domains of emotional, nonemotional, and social cognitive function in major depressive disorder. It examines the domains and descriptors of nonemotional cognitive function. It evaluates the important relationship between cognitive deficits and psychosocial function, as well as the clinical interactions between ‘cold’ and ‘hot’ cognitive function. It extends our understanding of the social cognitive function and its implications for social performance and impact on emotional and empathic performance.

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