Major Depressive Disorder Clinical Trial
Official title:
An Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced (Paroxetine), Fixed-dose Study on the Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder
Verified date | February 2017 |
Source | H. Lundbeck A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To assess the efficacy of acute treatment with 10 mg/day vortioxetine versus placebo on cognitive performance (focusing on the aspect concerning speed of processing, executive functioning, attention) in working patients with major depressive disorder (MDD).
Status | Completed |
Enrollment | 152 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - The patient has MDD, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™) recurrent major depressive disorder (MDD) (classification 296.3x). - The patient has a MADRS total score =26. - The patient has had the current major depressive episode (MDE) for =3 months. - The patient is aged =18 and =65 years. - The patient is employed full or part-time (defined as minimum 50% full time working hours per week). Part time work should not be due to a medical or mental illness other than MDD. - The patient has been in the current job/position for at least 3 months. - The patient has no plans to change jobs or retire within treatment period. - The patient is not on a sick leave, and at the Screening and Randomisation Visits, there are no plans to send the patient on a sick leave. - The patient is not receiving disability benefits. Exclusion criteria: - The patient has a score =70 on the DSST (number 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 or paroxetine. - The patient has any current psychiatric disorder or Axis I disorder (according to DSM-IV-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, or 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). Other protocol-defined inclusion and exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
Estonia | EE001 | Tallinn | |
Estonia | EE002 | Tallinn | |
Estonia | EE004 | Voru | |
Finland | FI002 | Helsinki | |
Finland | FI003 | Helsinki | |
Finland | FI001 | Kuopio | |
Finland | FI008 | Oulu | |
Finland | FI007 | Tampere | |
Germany | DE002 | Berlin | |
Germany | DE001 | Bielefeld | |
Germany | DE003 | Frankfurt | |
Germany | DE007 | Frankfurt | |
Germany | DE008 | Schwerin | |
Lithuania | LT002 | Kaunas | |
Lithuania | LT006 | Palanga | |
Lithuania | LT003 | Silute | |
Lithuania | LT001 | Vilnius | |
Lithuania | LT005 | Vilnius |
Lead Sponsor | Collaborator |
---|---|
H. Lundbeck A/S |
Estonia, Finland, Germany, Lithuania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Digit Symbol Substitution Test (DSST): number of correct symbols | Baseline to Week 8 | ||
Secondary | Change in Trail Making Test (TMT) score: TMT-A; speed of processing | Baseline to Week 8 | ||
Secondary | Change in TMT-B; executive functioning | Baseline to Week 8 | ||
Secondary | Change in reaction time score: Choice Reaction Time (CRT); attention | Baseline to Week 8 | ||
Secondary | Change in reaction time score: Simple Reaction Time (SRT); psychomotor speed) | Baseline to Week 8 | ||
Secondary | Change in Stroop Colour Naming Test (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 | Baseline to Week 8 | ||
Secondary | Change in Montgomery and Asberg Depression Rating Scale (MADRS) total score | Baseline to Week 8 | ||
Secondary | Change in Clinical Global Impression - Severity of Illness (CGI-S) | Baseline to Week 8 | ||
Secondary | Clinical Global Impression - Global Improvement (CGI-I) score | Week 8 | ||
Secondary | Change in the Functioning Assessment Short Test (FAST) total score | 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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