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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02272517
Other study ID # 15907A
Secondary ID 2014-000231-16
Status Completed
Phase Phase 3
First received October 21, 2014
Last updated February 27, 2017
Start date December 2014
Est. completion date March 2016

Study information

Verified date February 2017
Source H. Lundbeck A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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), <50% response to current treatment).

- The patient must have been treated by SSRI/SNRI monotherapy (citalopram, paroxetine, sertraline, duloxetine, or venlafaxine) for at least 6 weeks at licensed doses prior to the Screening Visit.

- The patient has a PHQ-9 total score =14.

- The patient has a MADRS total score = 22.

- The patient has had the current MDE for =1 year.

- The patient has a Perceived Deficits Questionnaire - Depression (PDQ-D) total score >25.

- The patient is a man or woman aged =18 and =65 years.

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).

Other protocol defined inclusion and exclusion criteria may apply.

Study Design


Intervention

Drug:
Vortioxetine 10-20 mg

Escitalopram 10-20 mg


Locations

Country Name City State
Finland FI005 Helsinki
Finland FI001 Kuopio
Finland FI006 Kupio
Finland FI007 Tampere
Finland FI004 Turku
Germany DE005 Bochum
Germany DE004 Mittweida
Serbia RS002 Belgrade
Serbia RS003 Belgrade
Serbia RS004 Belgrade
Serbia RS005 Belgrade
Serbia RS001 Kragujevac
Slovakia SK004 Bratislava
Slovakia SK001 Hronovce
Slovakia SK003 Levice
Slovakia SK002 Rimavska Sobota

Sponsors (1)

Lead Sponsor Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Finland,  Germany,  Serbia,  Slovakia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Digit Symbol Substitution Test (DSST) The DSST is recognised as covering all of the cognitive performance aspects: speed of processing, executive functioning, and attention Baseline to Week 8
Secondary Change in Rey Auditory Verbal Learning Test (RAVLT) Learning [acquisition] and memory [delayed recall]) Baseline to Week 8
Secondary Change in Trail Making Test A (TMT-A) Speed of processing Baseline to Week 8
Secondary Change in Trail Making Test B (TMT-B) Executive functioning Baseline to Week 8
Secondary Change in Reaction time score; CRT attention Baseline to Week 8
Secondary Change in reaction time score SRT - simple reaction time Baseline to week 8
Secondary Change in STROOP incongruent score Executive functioning Baseline to Week 8
Secondary Change in STROOP congruent score Speed of processing Baseline to Week 8
Secondary Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score Patient-reported cognitive function outcome including attention concentration, retrospective memory, prospective memory, and, planning organization Baseline to Week 8
Secondary Change in Patient Health Questionnaire-9 (depressive symptoms) (PHQ-9) total score Patient-reported outcome Baseline to Week 8
Secondary Change in Clinical Global Improvement - Severity (CGI-S) Baseline to Week 8
Secondary Clinical Global Improvement (CGI-I) Week 8
Secondary Change in Functioning Assessment Short Test (FAST) Baseline to Week 8
Secondary Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score Baseline to Week 8
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