Major Depressive Disorder and cognitive impairment MedDRA version: 17.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The patient has MDD, diagnosed according to DSM-IV-TR™ recurrent MDE (classification 296.3x) as confirmed using the Mini International Neuropsychiatric Interview (MINI). - The patient has depressive symptoms currently considered as non- or only partially responsive (inadequate response), to one adequate course of SSRI/SNRI antidepressant monotherapy and is candidate for a switch in the investigator's opinion. - The patient wants to stop taking his/her current SSRI/SNRI treatment due to inadequate response confirmed by the Antidepressant Treatment Response Questionnaire (ATRQ), 25. - The patient is a man or woman aged =18 and =65 years. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - The patient has a score =70 on the DSST (Number of Correct Symbols) at the Baseline Visit. - The patient has physical, cognitive, or language impairment of such severity as to adversely affect the validity of the data derived from the neuropsychological tests. - The patient has any current psychiatric disorder or Axis I disorder (according to DSMIV-TR™ criteria) other than MDD, as assessed using MINI. - The patient has a current or has had a diagnosis of dysthymic disorder within 3 months preceding the onset of current episode (DSM-IV-TR™ criteria). - The patient has borderline, schizotypal, schizoid, paranoid, histrionic, antisocial personality disorders (axis II) as comorbid or primary diagnosis (DSM-IV-TR™ criteria). - The patient has history of previous MDEs considered as treatment resistant defined as inadequate response (incomplete or no therapeutic response) to two prior courses of at least 6 weeks of conventional antidepressant drugs in adequate dosages or, the patient has treatment-resistant depression in the investigator's judgement. - The patient suffers from personality disorders, mental retardation, pervasive development disorder, attention-deficit/hyperactivity disorder, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria). - The patient has a diagnosis of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) (DSM-IV-TR™ criteria) that has not been in sustained full remission at least 2 years prior to the Screening Visit. - The patient has a current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features (DSM-IV-TR™ criteria).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study aims at evaluating the effect of vortioxetine on cognitive dysfunction in major depressive disorder (MDD) patients with inadequate response to current antidepressant treatment.;Secondary Objective: To assess the efficacy of vortioxetine versus escitalopram on cognitive dysfunction (performance and subjective reporting): speed of processing, executive functioning, attention, and learning and memory To assess the efficacy of vortioxetine versus escitalopram on: - depressive symptoms - clinical global impression - functionality To assess the safety and tolerability of vortioxetine ;Primary end point(s): Change in Digit Symbol Substitution Test (DSST);Timepoint(s) of evaluation of this end point: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Throughout the study;Secondary end point(s): - Change in Rey Auditory Verbal Learning Test (RAVLT) score: memory (delayed recall) and learning [acquisition]) - Change in Trail Making Test (TMT) score: TMT-A - Change in TMT score: TMT-B - Change in reaction time score: Choice Reaction Time (CRT) - Change in reaction time score: Simple Reaction Time (SRT) - Change in Stroop Colour Naming Test (STROOP): incongruent score - Change in STROOP: congruent score - Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score - Change in Patient Health Questionnaire-9 (depressive symptoms) (PHQ-9) total score - Change in Clinical Global Impression - Severity of Illness (CGI-S) - Clinical Global Impression - Global Improvement (CGI-I) score - Change in Functioning Assessment Short Test (FAST) - Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score - Number of adverse events - Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions (1, 2, 3, 4 and 7) | — |
Countries
Finland, Germany, Serbia, Slovakia, Ukraine
Contacts
Public ContactLundbeck Clinical Trials
H. Lundbeck A/S
Outcome results
None listed