NCT02724735

A Longitudinal Observational Cohort Study of NSI-189, With Out-Patients With Major Depressive Disorder

A Longitudinal Observational Cohort Study of NSI-189, a Neurogenic Compound Among Out-Patients With Major Depressive Disorder

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 220 (estimated)
• Sponsor: Neuralstem Inc. · Industry
• Sex: All
• Age: 18 Years – 61 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	NSI-189	0 Milligrams, 40 Milligrams or 80 Milligrams administered in the acute study only

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-12-01
• Completion: 2018-01-01
• First posted: 2016-03-31
• Last updated: 2016-09-21

Locations

12 sites across 1 country: United States