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A Safety and Efficacy Study of Ramelteon Tablets for Sublingual Administration (TAK-375SL) in the Maintenance Treatment of Bipolar 1 Disorder

NCT01685151 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2013-01-23

No results posted yet for this study

Summary

To evaluate the efficacy and safety of once a day ramelteon tablets for sublingual administration (TAK-375SL) in the maintenance treatment of bipolar 1 disorder.

Conditions

Interventions

DRUG

Ramelteon SL (Dose 1)

Ramelteon tablets for sublingual administration

DRUG

Ramelteon SL (Dose 2)

Ramelteon tablets for sublingual administration

DRUG

Placebo

Placebo

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
2012-09-30
Primary Completion
2015-11-30
Completion
2015-11-30

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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 NCT01685151 on ClinicalTrials.gov