InsomniaPhase 3NCT00585208
Add-On Ramelteon in Bipolar I Disorder With Clinically Significant Sleep Disturbance
A Phase 3 study testing Ramelteon in people with Insomnia and Bipolar Disorder, run by Lindner Center of HOPE at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia, Bipolar Disorder
- What is being tested?
- Ramelteon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Add-On Ramelteon in Ambulatory Bipolar I Disorder With Clinically Significant Sleep Disturbance
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.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, parallel-group, single site, 8-week trial of add-on ramelteon in outpatient adults (18-65 years old, inclusive) with lifetime bipolar I disorder, with mild to moderate manic symptoms, and currently experiencing a clinically significant sleep disturbance. Approximately 60 subjects will be screened to obtain 30 subjects who enroll in the 8-week trial. Subjects will be randomized to ramelteon or placebo in a double-blind manner as add-on to current treatment. Any other psychotropic medications that the subject is taking at the initiation of participation in this protocol should be continued unchanged throughout the course of this study, except in instances in which these medications require dose reduction for management of side effects. Efficacy and safety assessments will be performed weekly, and the presence of treatment-emergent adverse events will be monitored and recorded.
- Conditions
- Insomnia, Bipolar Disorder
- Being tested
- Ramelteon, Placebo
- Keywords
- insomnia, sleep disturbance, bipolar disorder
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Bipolar Disorder, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamelteonDrug
Also called Rozerem
Ramelteon 8mg daily
PlaceboDrug
matching placebo for ramelteon 8mg daily
| Study group | Role | What they receive |
|---|---|---|
| Active drug | Active comparator | Ramelteon - this group receives active drug at a fixed dose of 8mg daily throughout study Receives: Drug: Ramelteon |
| Placebo (sugar pill) | Placebo comparator | placebo (sugar pill) - this arm receive the fake pill, also know as placebo or the sugar pill Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
Measured: 8 weeks
Pittsburgh Insomnia Rating Scale (PIRS)
Measured: 8 weeks
Secondary outcomes (5)
Young Mania Rating Scale (YMRS)
Measured: 8 weeks
Inventory of Depressive Symptoms (IDS)
Measured: 8 weeks
Hamilton Anxiety Scale (HAM-A)
Measured: 8 weeks
Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP)
Measured: 8 weeks
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionSep 2010
- Study completionDec 2010
Why it stopped: sponsor terminated study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindner Center of HOPE
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda, University of Cincinnati
- Responsible party
- Sponsor
- Investigators
- Susan L McElroy, MD, Principal investigator, The Lindner Center of HOPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585208
- Sponsor's protocol ID
- 07-11-06-04
- Status last verified
- May 2013
- First submitted
- 20 Dec 2007
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20861739
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of Add-On Ramelteon in Ambulatory Bipolar I Disorder With Clinically Significant Sleep Disturbance
- ClinicalTrials.gov ID
- NCT00585208
- Acronym / sponsor ID
- 07-11-06-04
- Conditions
- Insomnia, Bipolar Disorder
- Keywords
- insomnia, sleep disturbance, bipolar disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor terminated study
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Lindner Center of HOPEUniversity, hospital or other
- Collaborators
- Takeda, University of Cincinnati
- Study start
- Dec 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, double-blind, placebo-controlled, parallel-group, single site, 8-week trial of add-on ramelteon in outpatient adults (18-65 years old, inclusive) with lifetime bipolar I disorder, with mild to moderate manic symptoms, and currently experiencing a clinically significant sleep disturbance. Approximately 60 subjects will be screened to obtain 30 subjects who enroll in the 8-week trial. Subjects will be randomized to ramelteon or placebo in a double-blind manner as add-on to current treatment. Any other psychotropic medications that the subject is taking at the initiation of participation in this protocol should be continued unchanged throughout the course of this study, except in instances in which these medications require dose reduction for management of side effects. Efficacy and safety assessments will be performed weekly, and the presence of treatment-emergent adverse events will be monitored and recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active drug | Active comparator | Drug: RamelteonRamelteon - this group receives active drug at a fixed dose of 8mg daily throughout study |
| Placebo (sugar pill) | Placebo comparator | Drug: Placeboplacebo (sugar pill) - this arm receive the fake pill, also know as placebo or the sugar pill |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RamelteonAlso: RozeremRamelteon 8mg daily | Drug | Active drug |
| Placebomatching placebo for ramelteon 8mg daily | Drug | Placebo (sugar pill) |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 8 weeks
Pittsburgh Insomnia Rating Scale (PIRS)
Time frame: 8 weeks
5 secondary outcomes
Young Mania Rating Scale (YMRS)
Time frame: 8 weeks
Inventory of Depressive Symptoms (IDS)
Time frame: 8 weeks
Hamilton Anxiety Scale (HAM-A)
Time frame: 8 weeks
Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP)
Time frame: 8 weeks
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: sponsor terminated study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
- Results publication: PubMed 20861739McElroy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan L McElroy, MD principal investigator
The Lindner Center of HOPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ramelteon in people with Insomnia and Bipolar Disorder, run by Lindner Center of HOPE at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: sponsor terminated study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00585208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2013; AzTrials last refreshed its copy on 6 Nov 2026.