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Study of NSI-189 for Major Depressive Disorder

NCT02695472 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2017-02-24

No results posted yet for this 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.

Conditions

Interventions

DRUG

80 Milligrams NSI-189

Orally Administered

DRUG

Placebo

Orally administered

DRUG

40 Milligrams NSI-189

Orally Administered

Sponsors & Collaborators

  • Neuralstem Inc.

    lead INDUSTRY

Principal Investigators

  • Karl Johe, Ph.D. · Neuralstem Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-06-30
Completion
2017-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02695472 on ClinicalTrials.gov