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

> **NCT01677182** · PHASE3 · TERMINATED · sponsor: **Takeda** · enrollment: 535 (actual)

## Conditions studied

- Bipolar Disorder

## Interventions

- **DRUG:** Ramelteon
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT01677182
- **Lead sponsor:** Takeda
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2012-08
- **Primary completion:** 2014-08
- **Final completion:** 2014-09
- **Target enrollment:** 535 (ACTUAL)
- **Why stopped:** Business Decision; Terminated due to futility, with no safety concerns (see below)
- **Last updated:** 2016-03-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01677182

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01677182, "Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT01677182. Licensed CC0.

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