An observational study in Major Depressive Disorder, sponsored by Neuralstem Inc.. Status unknown at 12 sites in United States. Open to participants aged 18 Years to 61 Years. Per ClinicalTrials.gov, last updated 2016-09-21.
Sponsored by Neuralstem Inc. · Observational
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's planned enrollment of 220 is above the median of 150 across 653 observational studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Neuralstem Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects having completed the randomized treatment period under the NS2014-1 clinical study protocol.
Exclusion Criteria:
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
Also known as: NSI-189 Phosphate
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).
Time frame: 6 months
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.
Time frame: 6 months
Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR)
Compare the continued antidepressant efficacy of NSI-189 with that of placebo.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 6 months
Massachusetts General Hospital Sexual Functioning Inventory (MGH SFI)
Characterize the safety and tolerability of NSI-189, compared to placebo.
Time frame: 6 months
The Columbia Suicide Severity Rating Scale (C-SSRS)
Characterize the safety and tolerability of NSI-189, compared to placebo.
Time frame: 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.
Time frame: 6 months
Discontinuation rates
Characterize the safety and tolerability of NSI-189, compared to placebo.
Time frame: 6 months
Plan to share: Yes
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Neuralstem Inc.