A long-term, open-label, flexible-dose, extension study evaluating the safety and tolerability of Lu AA21004 in patients with Major Depressive Disorder - Not applicable

• Conditions: Major Depressive Disorder; MedDRA version: 9.1Level: LLTClassification code 10025453Term: Major depressive disorder NOS

• Registration Number: EUCTR2007-004992-21-FI
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

A patient who meets all the following criteria, is eligible for inclusion in this study:

1.The patient is able to read and understand the Subject Information Sheet for the present study, different from the one for study 11984A.
2.The patient has signed the new Informed Consent Form, which is separate from the signed informed consent obtained for the study 11984A.
3.The patient must have completed study 11984A (Visit 7: Week 8) immediately prior to enrolment into the extension study.
4.The patient had a documented primary diagnosis of a Major Depressive Episode (MDE) at entry in study 11984A.
5.The patient, if female, must:
-agree not to try to become pregnant during the study, AND
-use adequate contraception (adequate contraception is defined as oral/systemic contraception, intrauterine device, diaphragm in combination with spermicide, or condom for male partner in combination with spermicide), OR
-have had her last natural menstruation at least 24 months prior to baseline, OR
-have been surgically sterilised prior to baseline, OR
-have had a hysterectomy prior to baseline, OR
-not be sexually active with men
6.The patient is indicated 12-month continuation treatment with Lu AA21004 according to the clinical opinion of the investigator.

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

Exclusion Criteria

In addition to the exclusion criteria applying for study 11984A (appendix V), and which are met at baseline visit, except criteria:
-7 (increased intra-ocular pressure or at risk of acute narrow-angle glaucoma
-9 (chronic liver disease)
-11 (history of lack of response to previous adequate treatment with duloxetine)
-17 (previous exposure to investigational drug)
-22 (previous exposure to Lu AA21004)

Patients who meet one or more of the following criteria are not eligible for inclusion in this study:
1.The patient with Major Depressive Disorder, for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia or any psychotic disorder) have been diagnosed during study 11984A.
2.The patient, in the investigator’s opinion has a significant risk of suicide, and/or a score of 5 points or higher on item 10 (suicidal thoughts) of the MADRS.
3.The patient is in the opinion of the investigator, unlikely to be able to comply with the clinical trial protocol or is unsuitable for any other reasons.
4.The patient has a clinically significant, moderate or severe ongoing adverse event, related to study medication in study 11984A.
5.The patient has used/ uses disallowed recent or concomitant medication (specified in Appendix II, Recent and Concomitant medication).

Study & Design

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