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Asenapine for Bipolar Depression

NCT01807741 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2017-07-24

No results posted yet for this study

Summary

The purpose of this study is to compare asenapine with placebo in the treatment of depression associated with bipolar disorder, type I over eight weeks.

We hypothesize that patients will show significantly greater improvement with asenapine than placebo over eight weeks of treatment.

Conditions

Interventions

DRUG

Asenapine

Available in 5 and 10 mg.

DRUG

Placebo

Sponsors & Collaborators

  • University of Louisville

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Caleb M Adler, MD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT01807741 on ClinicalTrials.gov