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Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression

NCT01670019 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2015-10-01

Study results available
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Summary

This is a 6-week comparison of asenapine versus placebo as an add-on to ongoing antidepressant treatment in patients with major depression who have not had a complete therapeutic response to treatment with the antidepressant alone.

The investigators hypothesize that added asenapine will produce greater reductions in depression than will added placebo.

Conditions

  • Major Depressive Disorder Without Psychotic Features

Interventions

DRUG

Asenapine 5-20 mg daily

5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID

DRUG

Placebo 1-4 tablets daily

One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID

Sponsors & Collaborators

Principal Investigators

  • John Beyer, MD · Duke University

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
2012-10-31
Primary Completion
2014-05-31
Completion
2014-06-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01670019 on ClinicalTrials.gov