Clinical trial NCT02724735: A Longitudinal Observational Cohort Study of NSI-189, With Out-Patients With Major Depressive Disorder
Official title: A Longitudinal Observational Cohort Study of NSI-189, a Neurogenic Compound Among Out-Patients With Major Depressive Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Depressive Disorder
Keywords: Depression
Major Depressive Disorder (MDD)
Major Depressive Disorder
Neurogenesis
Synaptogenesis
NSI-189
Neuralstem
Lead sponsor: Neuralstem Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-31
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects having completed the randomized treatment period under the NS2014-1 clinical study protocol.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Primary Objective: Durability of Effect defined as the time until the start of a new antidepressant treatment (ADT)
timeFrame: 6 months
Secondary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 6 months
measure: Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR)
timeFrame: 6 months
measure: Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH CPFQ)
timeFrame: 6 months
measure: Cogscreen Battery
timeFrame: 6 months
measure: Symptoms of Depression Questionnaire (SDQ)
timeFrame: 6 months
measure: Massachusetts General Hospital Sexual Functioning Inventory (MGH SFI)
timeFrame: 6 months
measure: The Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: 6 months
measure: 17-item Hamilton Depression Rating Scale (HAMD17)
timeFrame: 6 months
measure: Discontinuation rates
timeFrame: 6 months
Other outcomes:
Locations:
city: Garden Grove
country: United States
state: California
city: National City
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Jacksonville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Alpharetta
country: United States
state: Georgia
city: St. Louis
country: United States
state: Missouri
city: Staten Island
country: United States
state: New York
city: Dayton
country: United States
state: Ohio
city: Memphis
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Neuralstem Inc.
name: Karl Johe, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.