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

Status unconfirmed

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT02724735

Run by

Neuralstem Inc.

People needed

220

Starts

2016-08-01

Expected to finish

2018-01-01

Last updated by the study team

2016-09-21

Who can join

Age: 18 and older, up to 61. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Subjects taking excluded medications.
• 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.
• 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.

Where it is running

• Study site — Garden Grove, California, United States (enrolling)
• Study site — National City, California, United States (enrolling)
• Study site — Denver, Colorado, United States (enrolling)
• Study site — Jacksonville, Florida, United States (enrolling)
• Study site — Orlando, Florida, United States (enrolling)
• Study site — Alpharetta, Georgia, United States (enrolling)
• Study site — St Louis, Missouri, United States (enrolling)
• Study site — Staten Island, New York, United States (enrolling)
• Study site — Dayton, Ohio, United States (enrolling)
• Study site — Memphis, Tennessee, United States (enrolling)
• Study site — Dallas, Texas, United States (enrolling)
• Study site — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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