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Status:

COMPLETED

Efficacy Study of Vortioxetine on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder

Lead Sponsor:

H. Lundbeck A/S

Conditions:

Major Depressive Disorder

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

Brief 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 (attenti...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

598 Patients enrolled

Trial Details

Trial ID

NCT01422213

Start Date

December 1 2011

Last Update

August 5 2014

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