Efficacy Study of Lu AA21004 on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder



Status:Recruiting
Conditions:Cognitive Studies, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:5/27/2013
Start Date:December 2011
Contact:Email contact via H. Lundbeck A/S
Email:LundbeckClinicalTrials@lundbeck.com

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Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed Dose Study on the Efficacy of Lu AA21004 on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder (MDD)


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 Lu AA21004 versus placebo on cognitive dysfunction in adult patients
with Major Depressive Disorder.


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 Lu AA21004.

Other inclusion and exclusion criteria may apply.
We found this trial at
12
sites
St. Louis, Missouri 63118
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Arcadia, California 91007
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Birmingham, Alabama 35216
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Birmingham, AL
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Brooklyn, New York 11235
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Maitland, Florida 32751
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Maitland, FL
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Miami, Florida 33145
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Miami, FL
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National City, California 91950
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National City, CA
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New York, New York 12128
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New York, NY
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New York, New York 10021
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New York, NY
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Orange, California 92868
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Orange, CA
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Portland, Oregon 97210
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Portland, OR
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Torrance, California 90502
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Torrance, CA
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