A study of the new pharmaceutical LuAA21004 in comparison to agomelatine in adults suffering from major depression who did not respond well to previous medication.
- Conditions
- -Major Depressive Disorder (MDD)MedDRA version: 14.0Level: LLTClassification code 10025453Term: Major depressive disorder NOSSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2011-002362-21-DE
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
•The patient is a man or woman, between 18 and 75 years old (inclusive)
•The patient is being treated with an SRI antidepressant (monotherapy) that was prescribed to treat Major Depressive Episode (DSM-IV-TR criteria)
•The response to the current SRI treatment is inadequate and patient agrees to discontinue the current SRI at the baseline
•MADRS total score =22 at the Screening Visit and Baseline
•The patient, if a woman, must: agree not to try to become pregnant during the study, AND use adequate, highly effective contraception
Other protocol-defined inclusion criteria may 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 395
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 105
•The patient has any current Axis I disorders (DSM-IV criteria) other than MDD, GAD and SAD
•The patient is at significant risk of suicide
•The patient is currently receiving formal psychotherapy or otherpsychoactive medications
Other protocol-defined exclusion criteria may apply
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