Add-On Ramelteon in Bipolar I Disorder With Clinically Significant Sleep Disturbance

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Insomnia, Bipolar Disorder

In brief

The purpose of this research study is to evaluate the safety and efficacy of ramelteon (Rozerem™) as an add-on treatment for sleep problems in patients with bipolar disorder. This study will determine whether or not the addition of ramelteon to ongoing medication(s) for bipolar disorder is useful in improving sleep.

Key facts

Study ID

NCT00585208

Run by

Lindner Center of HOPE

People needed

21

Starts

2007-12-01

Expected to finish

2010-12-01

Last updated by the study team

2013-05-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must be 18 to 65 years of age, inclusive.
• Subjects must have lifetime bipolar I disorder as defined by DSM-IV-TR criteria.
• Subjects' manic symptoms must be mild to moderate in severity, defined as an YMRS score between 10 and 25.
• Subjects must be currently experiencing a clinically significant sleep disturbance, defined as a PSQI total score > 5.
• Subjects must be receiving at least 1 mood stabilizing medication, which may include an atypical antipsychotic (e.g., aripiprazole, clozapine, olanzapine, quetiapine, risperidone, ziprasidone) and/or mood stabilizer/anticonvulsant (e.g, lithium, carbamazepine, valproate/divalproex, lamotrigine, oxcarbazepine) medication for > 1 week prior to baseline. Continued administration of benzodiazepines or sedative-hypnotics will be allowed only if the subject has been receiving the medication for > 2 weeks prior to baseline.
• Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained.
• If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least 1 month prior to study entry and throughout the study.

You may not qualify if…

• Subjects who are experiencing clinically significant suicidal or homicidal ideation.
• Subjects who are currently experiencing psychotic symptoms.
• Subjects with a current DSM-IV-TR Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV-TR diagnosis of a substance dependence disorder within the past 6 months; or, a lifetime DSM-IV-TR psychotic disorder (e.g., schizophrenia or schizoaffective disorder).
• Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the investigator.
• Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement for > 3 months.
• Subjects with a clinically significant abnormality in their pre-study physical exam, vital signs, EKG, or laboratory studies.
• Subjects who are allergic to or who have demonstrated hypersensitivity to ramelteon.
• Subjects who are taking medications that interact with ramelteon (e.g., ketoconazole, fluconazole, fluvoxamine, rifampin).
• Females who are pregnant or nursing.
• Subjects who have received an experimental drug or used an experimental device within 30 days.

Where it is running

• The Lindner Center of HOPE — Mason, Ohio, United States

Full record on ClinicalTrials.gov

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