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AV-101 as Adjunct Antidepressant Therapy in Patients With Major Depression

NCT03078322 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2019-10-09

No results posted yet for this study

Summary

The study will evaluate the safety and efficacy of AV-101.

Conditions

Interventions

DRUG

AV-101

Oral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant)

DRUG

Placebo

Oral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Sponsors & Collaborators

  • VistaGen Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2019-10-01
Completion
2019-10-01
FDA Drug
Yes

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 NCT03078322 on ClinicalTrials.gov