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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NSI-189 | Drug | 0 Milligrams, 40 Milligrams or 80 Milligrams administered in the acute study only |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects having completed the randomized treatment period under the NS2014-1 clinical study protocol.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karl Johe, Ph.D. | Contact | NSI-189MDD@neuralstem.com |
| Name | Affiliation | Role |
|---|---|---|
| Karl Johe, Ph.D. | Neuralstem Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recruiting | Garden Grove | California | 92845 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26643541 | Background | 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. |
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| 6 months |
| Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR) | Compare the continued antidepressant efficacy of NSI-189 with that of placebo. | 6 months |
| Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH CPFQ) | 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. | 6 months |
| Cogscreen Battery | 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. | 6 months |
| Symptoms of Depression Questionnaire (SDQ) | Compare the continued efficacy of NSI-189 with that of placebo, as measured by the Symptoms of Depression Questionnaire (SDQ) | 6 months |
| Massachusetts General Hospital Sexual Functioning Inventory (MGH SFI) | Characterize the safety and tolerability of NSI-189, compared to placebo. | 6 months |
| The Columbia Suicide Severity Rating Scale (C-SSRS) | Characterize the safety and tolerability of NSI-189, compared to placebo. | 6 months |
| 17-item Hamilton Depression Rating Scale (HAMD17) | HAMD17 will be used to characterize the safety and tolerability of NSI-189, compared to placebo. | 6 months |
| Discontinuation rates | Characterize the safety and tolerability of NSI-189, compared to placebo. | 6 months |
| Recruiting |
| National City |
| California |
| 91950 |
| United States |
| Recruiting | Denver | Colorado | 80209 | United States |
| Recruiting | Jacksonville | Florida | 32256 | United States |
| Recruiting | Orlando | Florida | 32801 | United States |
| Recruiting | Alpharetta | Georgia | 30005 | United States |
| Recruiting | St Louis | Missouri | 63141 | United States |
| Recruiting | Staten Island | New York | 10312 | United States |
| Recruiting | Dayton | Ohio | 45417 | United States |
| Recruiting | Memphis | Tennessee | 38119 | United States |
| Recruiting | Dallas | Texas | 75231 | United States |
| Recruiting | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C000620627 | NSI-189 |
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