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-ES
- 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