Recruiting

NSI-189

Sponsor:

Neuralstem Inc.

Code:

NCT02724735

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 61

Healthy Volunteers: Not accepted

Interventions

NSI-189

Study Details

Brief 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.

Conditions

Major Depressive Disorder

Study ID

NCT02724735

Start date

Aug, 2016

Status verified date

Sep, 2016

Completion date

Jan, 2018

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 61

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

220 participants

Anticipated

Interventions and Outcome Measures

Arms

Longitudinal Observational Cohort

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.

Interventions

NSI-189

0 Milligrams, 40 Milligrams or 80 Milligrams administered in the acute study only

Primary outcome measure

  • Primary Objective: Durability of Effect defined as the time until the start of a new antidepressant treatment (ADT) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Karl Johe, Ph.D.

NSI-189MDD@neuralstem.com

Locations

Recruiting

Garden Grove, California, United States, 92845

Recruiting

National City, California, United States, 91950

Recruiting

Denver, Colorado, United States, 80209

Recruiting

Jacksonville, Florida, United States, 32256

Recruiting

Orlando, Florida, United States, 32801

Recruiting

Alpharetta, Georgia, United States, 30005

Recruiting

St. Louis, Missouri, United States, 63141

Recruiting

Staten Island, New York, United States, 10312

Recruiting

Dayton, Ohio, United States, 45417

Recruiting

Memphis, Tennessee, United States, 38119

Recruiting

Dallas, Texas, United States, 75231

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Neuralstem Inc.

Last update posted

Sep 21, 2016

Last verified

Sep, 2016

Keywords

  • Depression
  • Major Depressive Disorder (MDD)
  • Major Depressive Disorder
  • Neurogenesis
  • Synaptogenesis
  • NSI-189
  • Neuralstem

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Neuralstem Inc. on 2016-09-21.