# Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder

> **NCT01467700** · PHASE3 · TERMINATED · sponsor: **Takeda** · enrollment: 490 (actual)

## Conditions studied

- Acute Depressive Episode

## Interventions

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

## Key facts

- **NCT ID:** NCT01467700
- **Lead sponsor:** Takeda
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2011-12
- **Primary completion:** 2015-03
- **Final completion:** 2015-03
- **Target enrollment:** 490 (ACTUAL)
- **Why stopped:** Business Decision; No Safety Concerns
- **Last updated:** 2016-05-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01467700

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01467700, "Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT01467700. Licensed CC0.

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