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

• Status: Unknown status
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neuralstem Inc.

Criteria

Inclusion Criteria:

1. Subject has the ability to understand the purpose, potential benefits and risks of the study and to provide signed and dated informed consent, authorizing the use of protected health information in accordance with national and local Subject privacy regulations.

2. Subject completed the 12-week randomized treatment period and final study visit for the NS2014-1 clinical study.

Exclusion Criteria:

1. Subjects taking excluded medications.

2. Subject who, in the opinion of the Site Investigator, are unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study.

3. Subject who, in the opinion of the Site Investigator, are unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up and improbability of completing the clinical study.