A Longitudinal Observational Cohort Study of NSI-189, With Out-Patients With Major Depressive Disorder
1 other identifier
observational
220
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2016
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2016
CompletedFirst Posted
Study publicly available on registry
March 31, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedSeptember 21, 2016
September 1, 2016
1.3 years
March 15, 2016
September 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Objective: Durability of Effect defined as the time until the start of a new antidepressant treatment (ADT)
The primary objective is to determine the durability of effect of NSI-189 phosphate compared to placebo in subjects with Major Depressive Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5TH EDITION). Durability of effect is defined as the time until the start of a new antidepressant treatment (ADT).
6 months
Secondary Outcomes (9)
Montgomery-Asberg Depression Rating Scale (MADRS)
6 months
Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR)
6 months
Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH CPFQ)
6 months
Cogscreen Battery
6 months
Symptoms of Depression Questionnaire (SDQ)
6 months
- +4 more secondary outcomes
Study Arms (1)
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
0 Milligrams, 40 Milligrams or 80 Milligrams administered in the acute study only
Eligibility Criteria
Subjects having completed the randomized treatment period under the NS2014-1 clinical study protocol.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuralstem Inc.lead
Study Sites (12)
Unknown Facility
Garden Grove, California, 92845, United States
Unknown Facility
National City, California, 91950, United States
Unknown Facility
Denver, Colorado, 80209, United States
Unknown Facility
Jacksonville, Florida, 32256, United States
Unknown Facility
Orlando, Florida, 32801, United States
Unknown Facility
Alpharetta, Georgia, 30005, United States
Unknown Facility
St Louis, Missouri, 63141, United States
Unknown Facility
Staten Island, New York, 10312, United States
Unknown Facility
Dayton, Ohio, 45417, United States
Unknown Facility
Memphis, Tennessee, 38119, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Related Publications (1)
Fava M, Johe K, Ereshefsky L, Gertsik LG, English BA, Bilello JA, Thurmond LM, Johnstone J, Dickerson BC, Makris N, Hoeppner BB, Flynn M, Mischoulon D, Kinrys G, Freeman MP. A Phase 1B, randomized, double blind, placebo controlled, multiple-dose escalation study of NSI-189 phosphate, a neurogenic compound, in depressed patients. Mol Psychiatry. 2016 Oct;21(10):1372-80. doi: 10.1038/mp.2015.178. Epub 2015 Dec 8.
PMID: 26643541BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Karl Johe, Ph.D.
Neuralstem Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2016
First Posted
March 31, 2016
Study Start
August 1, 2016
Primary Completion
December 1, 2017
Study Completion
January 1, 2018
Last Updated
September 21, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share