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WithdrawnNCT01685151
A Safety and Efficacy Study of Ramelteon Tablets for Sublingual Administration (TAK-375SL) in the Maintenance Treatment of Bipolarity type I
Medication studyAges 18–75
Understand this study
Who could participate?
This study is for people with bipolarity. Listed age limits: 18 years to 75 years. Other eligibility criteria apply.
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
What to know before participating
A point to clarify
This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?
Things to check before joining
Study start dateSeptember 2012
- Recruitment status
- Withdrawn
- Enrollment listed in the registry
- 0
- Sponsor
- Takeda
- Sponsor type
- Unknown or unclear
- Study type
- Drug
- Intervention type
- Medication / drug
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
- Locations
- Not clearly listed
- Age range
- From 18 Years to 75 Years
- Official registry ID
- NCT01685151
- Official title
Show the full official title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375SL as an Adjunctive Therapy to Treatment-as-Usual in the Maintenance Treatment of Bipolar 1 Disorder in Adult Subjects
Recruitment & locations
WithdrawnLocations not listed
Questions about this study
Who is behind this study?
The study sponsor is Takeda.
Does this study involve medication?
Yes. The study involves medication, including Ramelteon SL (Dose 1), Ramelteon SL (Dose 2) and Placebo.
Who can participate?
This study is for people with bipolarity. Listed age limits: 18 years to 75 years. Other eligibility criteria apply.
Is this study still recruiting?
The registry lists this study as withdrawn.
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