NCT02695472

Study of NSI-189 for Major Depressive Disorder

A Phase 2, Double-Blind, Placebo-Controlled Study of NSI-189, a Neurogenic Compound Among Out-Patients With Major Depressive Disorder

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Neuralstem Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The screening period will range from a minimum of 14 days to a maximum of 28 days. The Investigators will determine that the subjects meet eligibility criteria and will collect the demographic and medical data permitting full characterization of the subject. The duration of the randomization period will be 12 weeks. Subjects who meet inclusion/exclusion criteria at the Baseline Visit will be randomized to NSI-189 80 milligrams/day, given as 40 milligrams twice per day, NSI-189 40 milligrams/day, given once a day, or placebo. The treatment will be double-blinded.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	80 Milligrams NSI-189	Orally Administered
DRUG	Placebo	Orally administered
DRUG	40 Milligrams NSI-189	Orally Administered

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-06-01
• Completion: 2017-12-01
• First posted: 2016-03-01
• Last updated: 2017-02-24

Locations

13 sites across 1 country: United States