← Back to Search

Neurogenic Drug

40 Milligrams NSI-189, total dose daily for Depression

Phase 2
Waitlist Available
Research Sponsored by Neuralstem Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights

Study Summary

The study will consist of a screening period and a randomized treatment. Approximately 220 subjects who meet eligibility during the screening period will be randomized to initiate a 12-week, double-blind treatment with NSI-189 80 milligrams/day (provided as 40 milligrams twice per day), NSI-189 40 milligrams once a day, or placebo.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Montgomery-Asberg Depression Rating Scale (MADRS)
Secondary outcome measures
17-item Hamilton Rating Scale for Depression (HAMD17)
Clinical Global Impressions - Severity and Improvement (CGI-S, CGI-I)
CogScreen
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 80 Milligrams NSI-189, total dose dailyExperimental Treatment1 Intervention
One 40 Milligrams NSI-189 tablet twice per day
Group II: 40 Milligrams NSI-189, total dose dailyExperimental Treatment2 Interventions
One 40 Milligrams NSI-189 tablet and 1 placebo tablet per day
Group III: Placebo ArmPlacebo Group1 Intervention
One Placebo tablet, twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Neuralstem Inc.Lead Sponsor
6 Previous Clinical Trials
325 Total Patients Enrolled
3 Trials studying Depression
281 Patients Enrolled for Depression
Karl Johe, Ph.D.Study DirectorNeuralstem Inc.
1 Previous Clinical Trials
220 Total Patients Enrolled
1 Trials studying Depression
220 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Kentucky
What site did they apply to?
Midwest Clinical Research Center, LLC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Study of NSI-189 for Major Depressive Disorder
2016. "Study of NSI-189 for Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02695472.
All > Mdd
~24 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top