Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Somerset Pharmaceuticals
• Assess the safety and efficacy of EMSAM (selegiline transdermal system) versus placebo in adolescents (aged 12 through 17 years) who meet criteria for Major Depressive Disorder (MDD) without psychotic features, single or recurrent
Age
12–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male / Female outpatients 12 to 17 years of age diagnosed with Major Depressive Disorder (MDD). (Must have a Children's Depression Rating Scale-Revised \[CDRS-R\] with a total score of at least 45 at screening.)
Female patients must test negative on a pregnancy at visit 1.
Weight and height must be greater than the 10th percentile according to age and height,
Assent and consent must be given.
You may not be if
Have a serious or unstable medical illness, psychological condition, clinically significant laboratory or ECG result, hypersensitivity to selegiline, or any other condition that in the opinion of the investigator would compromise participation in the study or be likely to lead to hospitalization during the course of the study.
Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, pervasive development disorder or borderline personality disorder, as determined by the investigator.
Have a risk of suicide
Female patients who are either pregnant, nursing or have recently given birth.
Use of any protocol prohibited medications or substances.
Clareo Health | Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression
