A study to investigate the effect of the drug Lu AA21004 on the intellectual function in people who suffer from depressio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

1. The subject has recurrent MDD as the primary diagnosis 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 V6.0.0).

2. The subject has received prescribed treatment for a previous episode of depression.

3. The subject has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score =26 at both screening and
baseline.

4. Subject reports subjective cognitive dysfunction (such as difficulty concentrating, slow thinking, and difficulty in
learning new things or remembering things).

5. The reported duration of the current MDE is at least 3 months.

6. The subject is a man or woman between 18 and 65 years old, inclusive.
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 587
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion Criteria

1. The subject has a score =70 on the Digit Symbol Substitution Test (DSST) (numbers correct) at the Baseline Visit.

2.The subject has 1 or more of the following:
– Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR (as assessed by the MINI, Version 6.0.0).
– Current or history of attention deficit hyperactivity disorder (ADHD), pervasive developmental disorder, manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general
medical condition as defined in the DSM-IV-TR.
– Current diagnosis of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as
defined in the DSM-IV-TR that has not been in sustained full remission for at least 2 years prior to Screening.
(Subject must also have negative urine drug screen prior to Baseline.)
– Presence or history of a clinically significant neurological disorder (including epilepsy).
– Neurodegenerative disorder (Alzheimer’s Disease, Parkinson’s Disease, multiple sclerosis, Huntington’s Disease, etc).
– Any DSM-IV Axis II disorder that might compromise the study.

3. The subject has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance.

4. The subject has physical, cognitive, or language impairment of such severity as to adversely affect the validity of the data derived from the neuropsychological tests.

5. The subject has a significant risk of suicide according to the investigator’s clinical judgment or has a score =5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 6 months.

6. The subject, in the opinion of the investigator, poses a risk of harm to others.

7. The subject has initiated formal cognitive or behavioral therapy, systemic psychotherapy within less than 6 months of study screening, or has plans to initiate such therapy during the study.

8. The subject has received electroconvulsive therapy, vagal nerve stimulation, or repetitive transcranial magnetic stimulation within 6 months prior to Screening.

9. 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.

10. The subject has a history of lack of response to previous adequate treatment with duloxetine.

11. The subject has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance.

Note: For the purposes of this protocol, the following conditions are considered unstable due to the potential impact on assessment of MDD response and/or cognitive status: pain disorders, chronic fatigue syndrome, fibromyalgia, obstructive sleep apnea, and known cases of HIV, HBV, and HCV.

12. The subject has thyroid stimulating hormone (TSH) outside the normal range at the Screening Visit.

Note: If TSH value is outside the normal range, a free T4 will be obtained. Subjects who have elevated TSH but normal T4 (i.e. subclinical hypothyroidism) will be excluded. For subjects who are on thyroid hormone replacement therapy, a lower TSH

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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Updated 8/8/2016