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

NCT00585208 | Terminated Phase 3

• 1 other identifier: 07-11-06-04
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia; Bipolar Disorder

Keywords

insomnia; sleep disturbance; bipolar disorder

Outcome Measures

Primary Outcomes (2)

• Pittsburgh Sleep Quality Index (PSQI)

  8 weeks

• Pittsburgh Insomnia Rating Scale (PIRS)

  8 weeks

Secondary Outcomes (5)

• Young Mania Rating Scale (YMRS)

  8 weeks

• Inventory of Depressive Symptoms (IDS)

  8 weeks

• Hamilton Anxiety Scale (HAM-A)

  8 weeks

• Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP)

  8 weeks

• Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

  8 weeks

Study Arms (2)

Active drug

ACTIVE COMPARATOR

Ramelteon - this group receives active drug at a fixed dose of 8mg daily throughout study

Drug: Ramelteon

Placebo (sugar pill)

PLACEBO COMPARATOR

placebo (sugar pill) - this arm receive the fake pill, also know as placebo or the sugar pill

Drug: Placebo

Interventions

Ramelteon DRUG

Ramelteon 8mg daily

Also known as: Rozerem

Active drug

Placebo DRUG

matching placebo for ramelteon 8mg daily

Placebo (sugar pill)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Lindner Center of HOPE: lead
• Takeda: collaborator
• University of Cincinnati: collaborator

Study Sites (1)

The Lindner Center of HOPE

Mason, Ohio, 45040, United States

Location

Related Publications (1)

• McElroy SL, Winstanley EL, Martens B, Patel NC, Mori N, Moeller D, McCoy J, Keck PE Jr. A randomized, placebo-controlled study of adjunctive ramelteon in ambulatory bipolar I disorder with manic symptoms and sleep disturbance. Int Clin Psychopharmacol. 2011 Jan;26(1):48-53. doi: 10.1097/YIC.0b013e3283400d35.

  PMID: 20861739 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Bipolar Disorder; Parasomnias

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Susan L McElroy, MD

  The Lindner Center of HOPE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: January 3, 2008
• Study Start: December 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 10, 2013

Record last verified: 2013-05

Locations

US (1)