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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01422213
First received: August 22, 2011
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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 Major Depressive Disorder.


Condition Intervention Phase
Major Depressive Disorder
Drug: Placebo
Drug: Vortioxetine 10 mg
Drug: Vortioxetine 20 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed Dose Study on the Efficacy of Lu AA21004 [Vortioxetine] on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder (MDD)

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Cognitive dysfunction: Speed of processing, executive functioning, learning and memory [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    Change from baseline to Week 8 using the composite z-score defined as the weighted sum of the z-scores in the Digit Symbol Substitution Test (DSST) [speed of processing, executive functioning] and the Rey Auditory Verbal Learning Task (RAVLT) [learning, memory]


Secondary Outcome Measures:
  • Cognitive dysfunction: Speed of processing, executive functioning [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    Change from baseline to Week 8 using the DSST (speed of processing, executive functioning)

  • Cognitive dysfunction: Learning [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    Change from baseline to Week 8 using the RAVLT (learning)

  • Cognitive dysfunction: memory [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    Change from baseline to Week 8 using the RAVLT (memory)

  • To evaluate the safety and tolerability of 10 mg/day and 20 mg/day Vortioxetine based on parameters such as adverse events, clinical safety laboratory tests and vital signs [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]

Enrollment: 598
Study Start Date: December 2011
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Orally, once daily for 8 weeks
Experimental: Vortioxetine 10 mg Drug: Vortioxetine 10 mg
Orally, once daily for 8 weeks
Other Name: Lu AA21004
Experimental: Vortioxetine 20 mg Drug: Vortioxetine 10 mg
Orally, once daily for 1 week
Other Name: Lu AA21004
Drug: Vortioxetine 20 mg
Orally, once daily for 7 weeks
Other Name: Lu AA21004

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 (numbers correct), ≥42 on the RAVLT (learning) and ≥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 inclusion and exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422213

  Show 77 Study Locations
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01422213     History of Changes
Other Study ID Numbers: 14122A, 2011-001572-19
Study First Received: August 22, 2011
Last Updated: June 13, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Finland: Finnish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Latvia: State Agency of Medicines
Mexico: Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Ukraine: Ministry of Health
United States: Food and Drug Administration

Keywords provided by H. Lundbeck A/S:
MDD
Cognitive dysfunction

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Cognition Disorders
Mood Disorders
Mental Disorders
Behavioral Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders

ClinicalTrials.gov processed this record on April 17, 2014