Efficacy Study of Vortioxetine on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Cognitive Dysfunction
Intervention: Placebo; Vortioxetine (Lu AA21004); Vortioxetine (Lu AA21004)
Intervention description: capsules; daily; orally; encapsulated tablets; daily; orally; encapsulated tablets; daily; orally
Intervention MeSH terms: Vortioxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 598.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: MDD; Cognitive dysfunction

Summary:

      Major Depressive Disorder (MDD) is a severe and common psychiatric disorder. Although MDD
      primarily involves mood disturbances, patients also usually present alterations in cognitive
      function (attention, memory, executive functioning and psychomotor speed). Even though
      antidepressants are suggested in the literature to potentially improve cognitive dysfunction
      in patients with MDD to some degree, there is a lack of adequate and well-controlled studies
      to investigate this effect. This study will evaluate the efficacy, safety and tolerability of
      a new antidepressant Vortioxetine versus placebo on cognitive dysfunction in adult patients
      with MDD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is an inpatient in a psychiatric hospital or an outpatient at a
             psychiatric setting at the time of the study entry.

          -  The patient is diagnosed with recurrent MDD according to DSM-IV-TR™ criteria
             (classification code 296.3x). The current Major Depressive Episode (MDE) should be
             confirmed using the Mini International Neuropsychiatric Interview (MINI).

          -  The patient has received prescribed treatment for a previous episode of depression.

          -  The patient has a MADRS total score ≥26.

          -  The reported duration of the current MDE is at least 3 months.

        Exclusion Criteria:

          -  The patient has a score ≥70 on the DSST (number of correct symbols), or ≥42 on the
             RAVLT (learning) or ≥14 on the RAVLT (memory) at the Baseline Visit.

          -  The patient has any current Axis I disorder (DSM-IV-TR™ criteria) other than MDD,
             confirmed using the MINI.

          -  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.

          -  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 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 is at significant risk of suicide or has a score ≥5 on Item 10 (suicidal
             thoughts) of the MADRS, or has attempted suicide <6 months prior to the Screening
             Visit.

          -  The patient has received electroconvulsive therapy <6 months prior to the Screening
             Visit.

          -  The current depressive symptoms are considered by the investigator to have been
             resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each at
             the recommended dose.

          -  The patient has a history of moderate or severe head trauma (for example, loss of
             consciousness for more than 1 hour) or other neurological disorders or systemic
             medical diseases that are, in the opinion of the investigator, likely to affect
             central nervous system functioning.

          -  The patient has a history of cancer, other than basal cell or Stage 1 squamous cell
             carcinoma of the skin, that has not been in remission for >5 years prior to the first
             drug dose.

          -  The patient has a clinically significant unstable illness, for example:

          -  cardiovascular disease

          -  seizure disorder or encephalopathy

          -  congestive heart failure

          -  cardiac hypertrophy

          -  arrhythmia

          -  bradycardia (pulse <50 bpm)

          -  respiratory disease

          -  hepatic impairment or renal insufficiency

          -  metabolic disorder

          -  endocrinological disorder

          -  gastrointestinal disorder

          -  haematological disorder

          -  infectious disorder

          -  any clinically significant immunological condition

          -  dermatological disorder

          -  venereal disease

          -  The patient has, at the Screening Visit, an abnormal ECG that is, in the
             investigator's opinion, clinically significant.

          -  The patient is, in the investigator's opinion, unlikely to comply with the protocol or
             is unsuitable for any reason.

          -  The patient has previously been exposed to Vortioxetine.

        Other protocol-defined inclusion and exclusion criteria may apply.