A Longitudinal Observational Cohort Study of NSI-189, With Out-Patients With Major Depressive Disorder
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 61 |
| Updated: | 4/21/2016 |
| Start Date: | July 2016 |
| End Date: | January 2018 |
| Contact: | Karl Johe, Ph.D. |
| Email: | NSI-189MDD@neuralstem.com |
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.
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.
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.
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.
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