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

2014-08-27 04:00:29 | BioPortfolio


The purpose of this study is to determine the efficacy and safety of Ramelteon, once daily (QD), sublingual (SL), in adult patients with acute depressive episodes associated with Bipolar I disorder.


Ramelteon sublingual formulation is being developed by Takeda Pharmaceutical Company Limited for maintenance therapy of Bipolar I disorder.

Participants will be seen twice during the first week of treatment, weekly during the first 2 weeks of treatment and then every 2 weeks up to the end of the 8-week treatment period. Participants who complete the 8-week treatment period will have a follow-up visit approximately seven days after the last visit. A safety follow-up phone call will be made 30 days after completion of the 8-week treatment period.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Acute Depressive Episode


Ramelteon SL, Ramelteon SL, Ramelteon SL, Placebo


United States





Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T04:00:29-0400

Clinical Trials [1585 Associated Clinical Trials listed on BioPortfolio]

Efficacy of Ramelteon on Insomnia Symptoms Associated With Jet Lag in Healthy Adult Volunteers

The purpose of this study to determine the degree to which ramelteon, once daily (QD), can reduce the insomnia symptoms associated with rapid, eastward travel across 5 time zones.

A Study of a Melatonin Receptor Agonist to Prevent Migraine

The purpose of this study is to see if ramelteon will reduce the number of migraine headaches over a 12 week period. The safety and tolerability of ramelteon will also be evaluated. Rame...

Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome

The purpose of this study is to evaluate the ability of ramelteon to advance the timing of sleep in individuals with delayed sleep phase syndrome.

Efficacy and Safety of Ramelteon Combined With Gabapentin in Treating Patients With Insomnia

The purpose of this study is to determine the efficacy and safety of ramelteon, once daily (QD), taken in combination with Gabapentin for treating insomnia.

Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy Adults

The purpose of this study is to determine the Pharmacokinetic profile, safety, and tolerability of ramelteon in adolescent subjects with insomnia and gender- and race-matched healthy adult...

PubMed Articles [8042 Associated PubMed Articles listed on BioPortfolio]

A survey of the effects of ramelteon on benzodiazepine-dependence: Comparison between a ramelteon add-on group and a continuous benzodiazepine administration group.

In general, long-term benzodiazepine hypnotics are prescribed for patients in whom it is difficult to reduce benzodiazepine hypnotics. Unlike benzodiazepine receptor (BZ)-mediated sleep agents, ramelt...

Melatonin receptor activation provides cerebral protection after traumatic brain injury by mitigating oxidative stress and inflammation via the Nrf2 signaling pathway.

Traumatic brain injury (TBI) is a principal cause of death and disability worldwide. Melatonin, a hormone made by the pineal gland, is known to have anti-inflammatory and antioxidant properties. In th...

Early Administration of Ramelteon in the ICU: Effects Deserve Further Study.

A Novel Study Design to Systematically Explore the Impact of Trial Methodology on Psychopharmacological Treatment Outcome in Patients with Depression.

Randomized, double-blind, placebo-controlled trials were developed to draw rather unbiased conclusions regarding the efficacy of antidepressants in the treatment of a major depressive episode (interna...

No evidence of seasonal variation in mild forms of depression.

Seasonal Affective Disorder (SAD) is ubiquitous in popular culture and has influenced psychiatric diagnosis with the inclusion of the seasonal pattern modifier for the Major Depressive Episode in DSM....

Medical and Biotech [MESH] Definitions

An episode of MYOCARDIAL ISCHEMIA that generally lasts longer than a transient anginal episode but that does not usually result in MYOCARDIAL INFARCTION.

Acute or chronic INFLAMMATION of the PANCREAS due to excessive ALCOHOL DRINKING. Alcoholic pancreatitis usually presents as an acute episode but it is a chronic progressive disease in alcoholics.

A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309)

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

More From BioPortfolio on "Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder"

Quick Search


Relevant Topics

Depression is a serious mental health condition, where sad feelings carry on for weeks or months and interfere with your life. The symptoms include feeling unhappy most of the time (but may feel a little better in the evenings), loosing interest in lif...

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...

Bipolar Disorders
Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks. Over half of Bipolar cases develops before the age of 25. Bipolar ...

Searches Linking to this Trial