| Study summary: |
|
The purpose of this study is to evaluate the efficacy of Lu AA21004, once daily (QD), compared with placebo in adults with major depressive disorder. The study is 3 months.
Inclusion Criteria:- Suffers from a major depressive episode recurrent as the primary diagnosis according to the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
- Has a MADRS total score of 26 or greater at Screening and Baseline Visits.
- Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.
Exclusion Criteria: - Has received Lu AA21004 in a previous clinical study.
- Has 1 or more the following:
- Any current psychiatric disorder other than Major Depressive Disorder as defined in the DSM-IV
- Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder defined in the DSM-IV-TR.
- Any substance disorder (except nicotine and caffeine) as defined in the DSM-IV-TR.
- Presence or history of a clinically significant neurological disorder (including epilepsy)
- Neurodegenerative disorder.
- Any Axis II disorder that might compromise the study.
Has a thyroid stimulating hormone value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator. Has clinically significant abnormal vital signs as determined by the investigator. Has an abnormal Electrocardiogram. Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal. Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy. Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma. Has a clinically significant unstable illness. Has a significant risk of suicide according to the investigator's opinion.
|
| Qualified participants must: |
|
• Be 18 to 75 years of age |
| Participants will receive: |
|
Free diagnostic assessments, physicals, ECG, lab work, and $50 compensation at each visit. |
| Study is available at: |
|
Pacific Institute for Medical Research
10921 Wilshire Blvd., Suite 702
Los Angeles CA 91041
View Clinic Location
If you meet the above criteria and live within 50 miles of this clinic please enter your information below and click "I Am Interested In This Study" to be contacted by the study coordinator.
or
Click "View Contact Phone Number" to get the clinic's phone number..
|