A study measuring the effect and safety of 10 or 20 mg/day of the study drug Lu AA21004 and placebo in the treatment of cognitive dysfunction (such as problems with the ability to think, learn and remember, plan, solve problems and concentrate) in adult patients with Major Depressive Disorder. Patients will be assigned to treatment based on computer-aided random draw and no one involved in the study will know what treatment is given until the whole study is finished

• Conditions: -Cognitive dysfunction-Major Depressive Disorder (MDD); MedDRA version: 14.0Level: PTClassification code 10057668Term: Cognitive disorderSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.0Level: LLTClassification code 10025453Term: Major depressive disorder NOSSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-001572-19-LV
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-28
• Last Update Posted: 19 August 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

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.

Other protocol-defined inclusion criteria apply.

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 585
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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 (Examples in protocol).
•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 Lu AA21004.

Other protocol-defined exclusion criteria apply.

Study & Design

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