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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALTO-300 WITH AN OPEN-LABEL EXTENSION IN ADULTS WITH MAJOR DEPRESSIVE DISORDER
Status: Recruiting
The purpose of this study is to evaluate the safety and effectiveness of ALTO-300, an investigational medication being studied for adults with Major Depressive Disorder (MDD). This study will compare ALTO-300 to a placebo to learn more about how the medication may improve symptoms of depression and to identify factors that may help predict who is most likely to benefit from treatment.
Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:
• ages 18-70 years old
• diagnosed with moderate to severe major depressive disorder (MDD)
• currently taking one approved antidepressant medication (SSRI, SNRI, or bupropion) for at least 6 weeks with no recent dose changes
Exclusion Criteria:
• diagnosed with fibromyalgia
• pregnant or breastfeeding
Conditions:
Mental Health & Addiction
Keywords:
agomelatine, ALTO-300, depression, Major Depressive Disorder, MDD
Study Contact: Dariush Kaveh - kave0005@umn.edu
Principal Investigator: Cristina Albott
Phase: PHASE2
IRB Number: STUDY00027511
See this study on ClinicalTrials.gov