Major Depressive Disorder Clinical Trial
Official title:
A Longitudinal Observational Cohort Study of NSI-189, a Neurogenic Compound Among Out-Patients With Major Depressive Disorder
All subjects completing the randomized treatment period in Protocol NS2014-1 will discontinue study drug and be asked to provide consent to be followed in this 6-month study, at their final safety visit. The study will consist of an enrollment visit, followed by bi-monthly in-clinic visits with monthly telephone visits between in-clinic visits.
Following completion of the NS2014-1 final study visit procedures, Subjects will be offered
the opportunity to enroll in this longitudinal observational cohort protocol to monitor
their depression and to assess durability of effect and long-term safety of NSI-189.
The Enrollment Visit begins when informed consent is signed.The duration of the follow-up
period will be up to 6 months, until the start of a new antidepressant treatment. Subjects
who provide consent will be seen for in-person visits every 8 weeks, with bi-monthly phone
visits occurring between in-person visits. Safety assessments and efficacy assessments will
be performed at each visit. No study drug will be taken during the Longitudinal
Observational Cohort study.
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Observational Model: Cohort, Time Perspective: Prospective
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