Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–71
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Documentation of completion of a Novartis AGO178C Double-blind Study in MDD patients.
Male and female adults, 18 through 71 years of age, inclusive (i.e., same age range as for Double-blind Study, but with upper age limit increased by 1-year to accommodate patients whose age increased during the Double-blind Study).
Female patients should continue to use effective contraception as defined in double-blind study protocol.
Male and female adults, 18 through 70 years of age, inclusive.
Diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.
Current episode ≥4 weeks.
CGI-Severity score ≥4 at Screening and Baseline.
You may not be if
Concomitant use of fluvoxamine.
Any significant medical condition that emerged during Double-blind Phase of a previous study, which may interfere with study participation and/or study assessments as assessed by the investigator.
History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder.
Any other current Axis I disorder other than MDD which is the focus of treatment.
Substance or alcohol abuse in the last 30 days, dependence in the last 6 months.
Prior exposure to agomelatine.
Female patients of childbearing potential who are not using effective contraception.
