Trial · NCT01467713
Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder
NCT01467713, Phase 3, Terminated, Takeda; results first posted 2016-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder. Trials, record NCT01467713. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01467713
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder
- NCT number
- NCT01467713
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 642 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Bipolar Disorder
- Interventions
- Ramelteon SL, Placebo
- First posted
- 2011-11-09
- Last updated
- 2016-05-16
- Results first posted
- 2016-05-16
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time From Randomization to Any Relapse | Randomization to Month 12 double-blind treatment period | The time from randomization to relapse over 12 months double-blind treatment period as determined by the Principal Investigator (PI) or defined by any of the following criteria: depression \[Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥16\]; mania/hypomania \[Young Mania Rating Scale (YMRS) total score ≥14\]; mixed episode \[MADRS score ≥16 and YMRS total score ≥16\]; or, whether participant receives psychiatric hospitalization for bipolar disorder, electroconvulsive therapy (ECT) or any psychotropic medication change prescribed for the treatment of depression, mania/hypomania or mixed episodes. |
| Secondary | Time From Randomization to Relapse Due to Depression | Randomization to Month 12 double-blind treatment period | Relapse due to depression determined by any of the following criteria during the 12-month double-blind treatment period: PI judgment, MADRS ≥16, psychiatry hospitalization, ECT or any psychotropic medication change prescribed for the treatment of depressive episodes. |
| Secondary | Time From Randomization to Relapse Due to Mania/Hypomania or Mixed Episode | Randomization to Month 12 double-blind treatment period | Relapse due to mania/hypomania or mixed episode is determined by any of the following criteria: PI judgment, mania/hypomania \[YMRS ≥16\], mixed episode \[MADRS ≥16 and YMRS ≥16\], psychiatry hospitalization, ECT or any psychotropic medication change prescribed for the treatment of mania/hypomania or mixed episodes. |
| Secondary | Time From Randomization to Relapse Due to Depression From PI Judgement and/or MADRS ≥16 | Randomization to Month 12 double-blind treatment period | The time from randomization to relapse event during the 12 month double-blind treatment period due to depression, determined by the PI judgement and/or a MADRS score ≥16. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms. |
| Secondary | Time From Randomization to Relapse Due to Mania/Hypomania | Randomization to 12 Month double-blind treatment period | Relapse due to mania/hypomania is determined by the primary investigator (PI) judgement and/or a YMRS total score ≥16. YMRS is a 11 item scale with four items scale to assess manic symptoms, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), with 7 items rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe) with higher scores reflecting greater levels of mania. The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60. |
| Secondary | Time From Randomization to Relapse Due to Mixed Episode | Randomization to Month 12 double-blind treatment period | Relapse due to Mixed episode is determined by PI judgement and/or MADRS score ≥16 and YMRS total score ≥16. MADRS is a 10-item scale that measures overall severity of depressive symptoms rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. YMRS is a four item scale to assess manic symptoms, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), with 7 items rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60. |
| Secondary | Time From Randomization to Relapse Due to Psychiatric Hospitalization for Bipolar Disorder | Randomization to Month 12 double-blind treatment period | The time from randomization to relapse event during the 12 months double-blind treatment period due to psychiatric hospitalization for bipolar disorder. |
| Secondary | Time From Randomization to Relapse Due to Electroconvulsive Therapy (ECT) Administration | Randomization to Month 12 double-blind treatment period | The time from randomization to relapse event during the 12 month double-blind treatment period due to ECT. |
| Secondary | Time From Randomization to Relapse Due to Psychotropic Medication Change Prescribed for the Treatment of Depression, Mania/Hypomania or Mixed Episodes | Randomization to Month 12 double-blind treatment period | The time from randomization to relapse event during the 12 month double-blind treatment period due to any psychotropic medication change prescribed for the treatment of depression, mania/hypomania or mixed episode(s). |
| Secondary | Time From Randomization to Study Withdrawal for Any Reason | Randomization to Month 12 double-blind treatment period | The time from randomization to study withdrawal during the 12 month double-blind treatment period. Withdrawal includes pretreatment event/adverse event; liver function test abnormalities; major protocol deviation; lost to follow-up; voluntary withdrawal; study termination; pregnancy; lack of efficacy; participant has a depressive, mania/hypomania or mixed episode; is hospitalized for psychiatric reasons; receives electroconvulsive therapy for bipolar disorder; receives any psychotropic medication change prescribed for the treatment of depression, mania/hypomania or mixed episodes; or any other reason. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time From Randomization to Any Relapse | Randomization to Month 12 double-blind treatment period | Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored. | Days | MEAN |
| SECONDARY | Time From Randomization to Relapse Due to Depression | Randomization to Month 12 double-blind treatment period | Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored. | Days | MEAN |
| SECONDARY | Time From Randomization to Relapse Due to Mania/Hypomania or Mixed Episode | Randomization to Month 12 double-blind treatment period | Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored. | days | MEAN |
| SECONDARY | Time From Randomization to Relapse Due to Depression From PI Judgement and/or MADRS ≥16 | Randomization to Month 12 double-blind treatment period | Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored. | days | MEAN |
| SECONDARY | Time From Randomization to Relapse Due to Mania/Hypomania | Randomization to 12 Month double-blind treatment period | Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored. | days | MEAN |
| SECONDARY | Time From Randomization to Relapse Due to Mixed Episode | Randomization to Month 12 double-blind treatment period | Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored. | days | MEAN |
| SECONDARY | Time From Randomization to Relapse Due to Psychiatric Hospitalization for Bipolar Disorder | Randomization to Month 12 double-blind treatment period | Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored. | days | MEAN |
| SECONDARY | Time From Randomization to Relapse Due to Electroconvulsive Therapy (ECT) Administration | Randomization to Month 12 double-blind treatment period | Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored. | days | MEAN |
| SECONDARY | Time From Randomization to Relapse Due to Psychotropic Medication Change Prescribed for the Treatment of Depression, Mania/Hypomania or Mixed Episodes | Randomization to Month 12 double-blind treatment period | Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored. | days | MEAN |
| SECONDARY | Time From Randomization to Study Withdrawal for Any Reason | Randomization to Month 12 double-blind treatment period | Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. | days | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time From Randomization to Any Relapse | Placebo | 248.3 | Standard Error 8.11 | Days | |
| Time From Randomization to Any Relapse | Ramelteon SL 0.1 mg | 287.7 | Standard Error 8.83 | Days | |
| Time From Randomization to Any Relapse | Ramelteon SL 0.4 mg | 253.1 | Standard Error 7.52 | Days | |
| Time From Randomization to Any Relapse | Ramelteon SL 0.8 mg | 223.9 | Standard Error 7.60 | Days | |
| Time From Randomization to Relapse Due to Depression | Placebo | 256.5 | Standard Error 7.70 | Days | |
| Time From Randomization to Relapse Due to Depression | Ramelteon SL 0.1 mg | 242.1 | Standard Error 5.56 | Days | |
| Time From Randomization to Relapse Due to Depression | Ramelteon SL 0.4 mg | 260.8 | Standard Error 7.03 | Days | |
| Time From Randomization to Relapse Due to Depression | Ramelteon SL 0.8 mg | 224.2 | Standard Error 6.31 | Days | |
| Time From Randomization to Relapse Due to Mania/Hypomania or Mixed Episode | Placebo | 150.2 | Standard Error 1.60 | days | |
| Time From Randomization to Relapse Due to Mania/Hypomania or Mixed Episode | Ramelteon SL 0.1 mg | 319.3 | Standard Error 6.07 | days |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 164 | |
| Overall Study | STARTED | Ramelteon SL 0.1 mg | 164 | |
| Overall Study | STARTED | Ramelteon SL 0.4 mg | 160 | |
| Overall Study | STARTED | Ramelteon SL 0.8 mg | 154 | |
| Overall Study | Safety Analysis Set: Received Treatment | Placebo | 163 | |
| Overall Study | Safety Analysis Set: Received Treatment | Ramelteon SL 0.1 mg | 164 | |
| Overall Study | Safety Analysis Set: Received Treatment | Ramelteon SL 0.4 mg | 159 | |
| Overall Study | Safety Analysis Set: Received Treatment | Ramelteon SL 0.8 mg | 154 | |
| Overall Study | COMPLETED | Placebo | 62 | |
| Overall Study | COMPLETED | Ramelteon SL 0.1 mg | 60 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events164
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 7 | 163 | |
| other | Diarrhoea | Gastrointestinal disorders | Ramelteon SL 0.1 mg | 10 | 164 | |
| other | Diarrhoea | Gastrointestinal disorders | Ramelteon SL 0.4 mg | 2 | 159 | |
| other | Diarrhoea | Gastrointestinal disorders | Ramelteon SL 0.8 mg | 5 | 154 | |
| other | Influenza | Infections and infestations | Placebo | 3 | 163 | |
| other | Influenza | Infections and infestations | Ramelteon SL 0.1 mg | 6 | 164 | |
| other | Influenza | Infections and infestations | Ramelteon SL 0.4 mg | 8 | 159 | |
| other | Influenza | Infections and infestations | Ramelteon SL 0.8 mg | 5 | 154 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 11 | 163 | |
| other | Nasopharyngitis | Infections and infestations | Ramelteon SL 0.1 mg | 6 | 164 |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Ramelteon SL 0.1 mg | ||
| Total, all-cause mortality | Ramelteon SL 0.4 mg | ||
| Total, all-cause mortality | Ramelteon SL 0.8 mg | ||
| Total, other adverse events | Placebo | 55 | 163 |
| Total, other adverse events | Ramelteon SL 0.1 mg | 47 | 164 |
| Total, other adverse events | Ramelteon SL 0.4 mg | 49 | 159 |
| Total, other adverse events | Ramelteon SL 0.8 mg | 50 | 154 |
| Total, serious adverse events | Placebo | 10 | 163 |
| Total, serious adverse events | Ramelteon SL 0.1 mg | 14 | 164 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28662460 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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