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Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder

NCT01677182 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 535

Last updated 2016-03-16

Study results available
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Summary

To evaluate the efficacy of ramelteon for treatment of acute depressive episodes associated with Bipolar 1 Disorder.

Conditions

Interventions

DRUG

Ramelteon

Ramelteon tablets for sublingual administration

DRUG

Placebo

Ramelteon placebo-matching tablets for sublingual administration

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda Global Research and Development Center, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-08-31
Completion
2014-09-30

Countries

  • United States
  • Bulgaria
  • Czechia
  • Germany
  • Poland
  • Romania
  • Russia
  • Serbia
  • Ukraine
  • United Kingdom

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 NCT01677182 on ClinicalTrials.gov