A study to evaluate the cognitive effect of a product named vortioxetine (used in depression). These effects willbe compared to those induced by a marketed comparator and a placebo. Investigator and subjects will be blinded.

Phase 1

• Conditions: Major Depressive Disorder and cognitive impairment; MedDRA version: 17.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2014-000229-19-DE
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-07
• Last Update Posted: 4 July 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

- The patient has achieved either partial (some symptoms of a MDE are present but full criteria are not met) or full remission of major depressive disorder (MDD), diagnosed according to DSM-IV-TR™.
- The patient has HAMD-17 total score =10.
- The patient has received SSRI monotherapy for the MDE from which the patient is currently in full or partial remission for =12 weeks at licensed doses and been on stable dose =8 weeks prior to Screening Visit.
- The patient has =50% response to current SSRI treatment (Antidepressant Treatment Response Questionnaire [ATRQ]).
- The patient has a PDQ-D total score >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) yes
F.1.2.1 Number of subjects for this age range 185
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- The patient has a score =70 on the DSST (numbers of correct symbols) at the Baseline Visit.
- The patient is, in the opinion of the investigator, not able to complete the neuropsychological tests validly 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 is diagnosed with reading disability (dyslexia).
- The patient has a history of lack of response to previous adequate treatment with vortioxetine.
- The patient has any current psychiatric disorder or Axis I disorder (according to DSM-IV-TR™ criteria) other than MDD, as assessed using Mini International Neuropsychiatric Interview (MINI).
- The patient has a current or has had a diagnosis of dysthymic disorder within 3 months preceding the onset of the depressive episode from which the patient is currently in full or partial remission (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 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 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified