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

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ClinicalTrials.gov Identifier: NCT02724735
Recruitment Status : Unknown
Verified September 2016 by Neuralstem Inc..
Recruitment status was:  Recruiting
First Posted : March 31, 2016
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):
Neuralstem Inc.

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.

Condition or disease Intervention/treatment
Major Depressive Disorder Drug: NSI-189

Detailed Description:

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.


Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Longitudinal Observational Cohort Study of NSI-189, a Neurogenic Compound Among Out-Patients With Major Depressive Disorder
Study Start Date : August 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Drug: NSI-189
0 Milligrams, 40 Milligrams or 80 Milligrams administered in the acute study only
Other Name: NSI-189 Phosphate




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


Secondary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 6 months ]
    Compare the continued Montgomery-Asberg Depression Rating Scale (MADRS) response and remission rates of subjects treated with NSI-189 to those of subjects assigned to placebo. Response is defined as a 50% or greater reduction from baseline to endpoint on the Montgomery-Asberg Depression Rating Scale (MADRS) total score. Remission is defined as an endpoint MADRS total score of 10. The duration of 50% or greater reduction in Montgomery-Asberg Depression Rating Scale (MADRS) total score sustained following treatment will be noted.

  2. Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR) [ Time Frame: 6 months ]
    Compare the continued antidepressant efficacy of NSI-189 with that of placebo.

  3. Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH CPFQ) [ Time Frame: 6 months ]
    Evaluate the continued efficacy of NSI-189 compared to placebo on the cognitive aspects associated with Major Depressive Disorder, and the onset and duration of improvement.

  4. Cogscreen Battery [ Time Frame: 6 months ]
    Evaluate the continued efficacy of NSI-189 compared to placebo on the cognitive aspects associated with Major Depressive Disorder, and the onset and duration of improvement.

  5. Symptoms of Depression Questionnaire (SDQ) [ Time Frame: 6 months ]
    Compare the continued efficacy of NSI-189 with that of placebo, as measured by the Symptoms of Depression Questionnaire (SDQ)

  6. Massachusetts General Hospital Sexual Functioning Inventory (MGH SFI) [ Time Frame: 6 months ]
    Characterize the safety and tolerability of NSI-189, compared to placebo.

  7. The Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 6 months ]
    Characterize the safety and tolerability of NSI-189, compared to placebo.

  8. 17-item Hamilton Depression Rating Scale (HAMD17) [ Time Frame: 6 months ]
    HAMD17 will be used to characterize the safety and tolerability of NSI-189, compared to placebo.

  9. Discontinuation rates [ Time Frame: 6 months ]
    Characterize the safety and tolerability of NSI-189, compared to placebo.



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Ages Eligible for Study:   18 Years to 61 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects having completed the randomized treatment period under the NS2014-1 clinical study protocol.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02724735


Contacts
Contact: Karl Johe, Ph.D. NSI-189MDD@neuralstem.com

Locations
United States, California
Recruiting
Garden Grove, California, United States, 92845
Recruiting
National City, California, United States, 91950
United States, Colorado
Recruiting
Denver, Colorado, United States, 80209
United States, Florida
Recruiting
Jacksonville, Florida, United States, 32256
Recruiting
Orlando, Florida, United States, 32801
United States, Georgia
Recruiting
Alpharetta, Georgia, United States, 30005
United States, Missouri
Recruiting
St. Louis, Missouri, United States, 63141
United States, New York
Recruiting
Staten Island, New York, United States, 10312
United States, Ohio
Recruiting
Dayton, Ohio, United States, 45417
United States, Tennessee
Recruiting
Memphis, Tennessee, United States, 38119
United States, Texas
Recruiting
Dallas, Texas, United States, 75231
Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Neuralstem Inc.
Investigators
Study Director: Karl Johe, Ph.D. Neuralstem Inc.

Publications:
Responsible Party: Neuralstem Inc.
ClinicalTrials.gov Identifier: NCT02724735     History of Changes
Other Study ID Numbers: NS2015-2
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Neuralstem Inc.:
Depression
Major Depressive Disorder (MDD)
Major Depressive Disorder
Neurogenesis
Synaptogenesis
NSI-189
Neuralstem

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms