A Longitudinal Observational Cohort Study of NSI-189, With Out-Patients With Major Depressive Disorder
NCT ID: NCT02724735
Last Updated: 2016-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
220 participants
OBSERVATIONAL
2016-08-31
2018-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
NSI-189
0 Milligrams, 40 Milligrams or 80 Milligrams administered in the acute study only
Interventions
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NSI-189
0 Milligrams, 40 Milligrams or 80 Milligrams administered in the acute study only
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject completed the 12-week randomized treatment period and final study visit for the NS2014-1 clinical study.
Exclusion Criteria
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.
18 Years
61 Years
ALL
No
Sponsors
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Neuralstem Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Karl Johe, Ph.D.
Role: STUDY_DIRECTOR
Neuralstem Inc.
Locations
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Garden Grove, California, United States
National City, California, United States
Denver, Colorado, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Alpharetta, Georgia, United States
St Louis, Missouri, United States
Staten Island, New York, United States
Dayton, Ohio, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Countries
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Central Contacts
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References
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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.
Other Identifiers
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NS2015-2
Identifier Type: -
Identifier Source: org_study_id
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