Trial · NCT01358357
Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex
NCT01358357, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2016-07-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex. Trials, record NCT01358357. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01358357
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex
- NCT number
- NCT01358357
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 965 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Bipolar I Disorder
- Interventions
- Lurasidone, Placebo
- First posted
- 2011-05-23
- Last updated
- 2016-09-07
- Other registries' IDs
- eudract:2011-000986-10
- Results first posted
- 2016-07-26
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Recurrence of Mood Event During the Double Blind Treatment Phase | 28 weeks (up to 33 weeks) | A mood event is defined as one of the following during the double-blind phase: (1) Fulfilled Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision (DSM-IV-TR) criteria for manic, mixed manic, hypomanic, or depressive episode. (2) Required treatment intervention for manic, mixed manic, hypomanic, or depressive symptoms with any antipsychotic (other than study drug), antidepressant, mood stabilizer (other than lithium or divalproex), anxiolytic agents, benzodiazepine (beyond dosage allowed for anxiety, agitation, or insomnia). (3) Psychiatric hospitalization for any bipolar mood episode. (4) Young Mania Rating Scale (YMRS) or Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 18 or Clinical Global Impression Bipolar Version, Severity of Illness (CGI BP S) score ≥ 4 at 2 consecutive assessments no more than 10 days apart. (5) Discontinuation from the study because of a mood event (as determined by the Investigator). |
| Secondary | Time to All-cause Discontinuation | 28 weeks (up to 33 weeks) | |
| Secondary | Time to Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode | 28 weeks (up to 33 weeks) | |
| Secondary | Percentage of Subjects Who Experience a Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode | 28 weeks | |
| Secondary | Change From Double-blind Baseline to Week 28 (LOCF) in CGI-BP-S Overall Score | Double-blind Baseline to week 28 | The CGI-BP-S overall score is a single value, clinician-rated assessment of overall bipolar illness severity and ranges from 1=Normal, not at all ill, to 7=Among the most extremely ill patients. a higher score is associated with greater illness severity. |
| Secondary | Change From Double -Blind Baseline to Week 28 (LOCF) in CGI-BP-S Mania Score | Double-blind Baseline to week 28 | The CGI-BP-S mania score is a single value, clinician-rated assessment of mania illness severity and ranges from 1=Normal, not at all ill to 7=Among the most extremely ill patients. A high score is associated with greater illness severity |
| Secondary | Change From Double-blind Baseline to Week 28 (LOCF) in CGI+-BP-S Depression Score | Double-blind Baseline to week 28 | The CGI-BP-S depression score is a single value, clinician-rated assessment of depression illness severity and ranges from 1=Normal, not at all ill to 7=Among the most extremely ill patients. A higher score is associated with a greater illness severity. |
| Secondary | Change From Double-blind Baseline to Week 28 (LOCF) in YMRS Total Score | Double-blind Baseline to week 28 | the YMRS is an 11-item instrument used to assess the severity of mania in subjects with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score). The YMRS total score is calculated as the sum of the 11 items. The YMRS total score ranges from 0 to 60. Higher scores are associated with greater severity of maia. |
| Secondary | Change From Double-blind Baseline to Week 28 (LOCF) in MADRS Total Score | Double-blind Baseline to week 28 | The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity of depressive symptoms. |
| Secondary | Change Fro Double-blind Baseline to Week 28 (LOCF) in QIDS-SR(16) Total Score | Double-blind Baseline to week 28 | The QIDS-SR16 is a 16-item self-report measure of depressive symptomatology which uses a computerized assessment interface for administration. The scoring system for the QIDS-SR16 converts responses to 16 separate items into nine DSM-IV symptom criterion domains. The nine domains comprise: depressed mood (Item 5); concentration/decision making (Item 10); self outlook (Item 11); suicidal ideation (Item 12); decreased interest (Item 13); decreased energy (Item 14); sleep disturbance (initial, middle, and late insomnia or hypersomnia) (highest score of Items 1 to 4); appetite/weight disturbance (highest score of Items 6 to 9); and psychomotor disturbance (highest score of Items 15 and 16). The QIDS-SR16 total score is calculated as the sum of the 9 domain scores. The QIDS-SR16 total score ranges from 0 to 27 with a high score indicating more severe symptoms. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Recurrence of Mood Event During the Double Blind Treatment Phase | 28 weeks (up to 33 weeks) | ITT (Intent to treat) population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. | Days | MEDIAN |
| SECONDARY | Time to All-cause Discontinuation | 28 weeks (up to 33 weeks) | ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. | Days | MEDIAN |
| SECONDARY | Time to Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode | 28 weeks (up to 33 weeks) | ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. | Days | MEDIAN |
| SECONDARY | Percentage of Subjects Who Experience a Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode | 28 weeks | ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. | percentage of participants | NUMBER |
| SECONDARY | Change From Double-blind Baseline to Week 28 (LOCF) in CGI-BP-S Overall Score | Double-blind Baseline to week 28 | ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 2 lurasidone + Li/VPA subjects did not have post-DB baseline CGI-BP-S overall score. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Double -Blind Baseline to Week 28 (LOCF) in CGI-BP-S Mania Score | Double-blind Baseline to week 28 | ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 2 lurasidone + Li/VPA subjects did not have post-DB baseline CGI-BP-S mania score. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Double-blind Baseline to Week 28 (LOCF) in CGI+-BP-S Depression Score | Double-blind Baseline to week 28 | ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 2 lurasidone + Li/VPA subjects did not have post-DB baseline CGI-BP-S depression score. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Double-blind Baseline to Week 28 (LOCF) in YMRS Total Score | Double-blind Baseline to week 28 | ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 2 lurasidone + Li/VPA subjects did not have post-DB baseline YMRS total score. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Double-blind Baseline to Week 28 (LOCF) in MADRS Total Score | Double-blind Baseline to week 28 | ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 2 lurasidone + Li/VPA subjects did not have post-DB baseline MADRS total score. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change Fro Double-blind Baseline to Week 28 (LOCF) in QIDS-SR(16) Total Score | Double-blind Baseline to week 28 | ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 7 lurasidone + Li/VPA subjects and 7 placebo +Li/VPA subjects did not have post-DB baseline QIDS-SR16 total score. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Recurrence of Mood Event During the Double Blind Treatment Phase | Lurasidone 20-80 mg Flexible Dose | NA | 95% Confidence Interval NA to NA | Days | |
| Time to Recurrence of Mood Event During the Double Blind Treatment Phase | Placebo | 207 | 95% Confidence Interval 207 to NA | Days | |
| Time to All-cause Discontinuation | Lurasidone 20-80 mg Flexible Dose | 225 | 95% Confidence Interval 204 to 233 | Days | |
| Time to All-cause Discontinuation | Placebo | 207 | 95% Confidence Interval 207 to 216 | Days | |
| Time to Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode | Lurasidone 20-80 mg Flexible Dose | NA | 95% Confidence Interval NA to NA | Days | |
| Time to Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode | Placebo | NA | 95% Confidence Interval 207 to NA | Days | |
| Percentage of Subjects Who Experience a Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode | Lurasidone 20-80 mg Flexible Dose | 16.7 | percentage of participants | ||
| Percentage of Subjects Who Experience a Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode | Placebo | 21.6 | percentage of participants | ||
| Change From Double-blind Baseline to Week 28 (LOCF) in CGI-BP-S Overall Score | Lurasidone 20-80 mg Flexible Dose | 0.40 | Standard Error 0.085 | units on a scale | |
| Change From Double-blind Baseline to Week 28 (LOCF) in CGI-BP-S Overall Score | Placebo | 0.49 | Standard Error 0.085 | units on a scale |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open Label Phase | STARTED | Lurasidone 20-80 mg Flexible Dose | 0 | |
| Open Label Phase | STARTED | Placebo | 0 | |
| Open Label Phase | STARTED | All Subjects | 965 | |
| Open Label Phase | COMPLETED | Lurasidone 20-80 mg Flexible Dose | 0 | |
| Open Label Phase | COMPLETED | Placebo | 0 | |
| Open Label Phase | COMPLETED | All Subjects | 503 | |
| Open Label Phase | NOT COMPLETED | Lurasidone 20-80 mg Flexible Dose | 0 | |
| Open Label Phase | NOT COMPLETED | Placebo | 0 | |
| Open Label Phase | NOT COMPLETED | All Subjects | 462 | |
| Double-Blind Phase | STARTED | Lurasidone 20-80 mg Flexible Dose | 246 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events186
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 | Nausea | Gastrointestinal disorders | Lurasidone 20-80 mg Flexible Dose | 0 | 246 | 0 |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 250 | 0 |
| other | Nausea | Gastrointestinal disorders | All Subjects | 111 | 962 | 126 |
| other | Vomiting | Gastrointestinal disorders | Lurasidone 20-80 mg Flexible Dose | 0 | 246 | 0 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 0 | 250 | 0 |
| other | Vomiting | Gastrointestinal disorders | All Subjects | 59 | 962 | 66 |
| other | Diarrhoea | Gastrointestinal disorders | Lurasidone 20-80 mg Flexible Dose | 0 | 246 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 0 | 250 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | All Subjects | 53 | 962 | 56 |
| other | Fatigue | Gastrointestinal disorders | Lurasidone 20-80 mg Flexible Dose | 0 | 246 | 0 |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lurasidone 20-80 mg Flexible Dose | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | All Subjects | ||
| Total, other adverse events | Lurasidone 20-80 mg Flexible Dose | 81 | 246 |
| Total, other adverse events | Placebo | 81 | 250 |
| Total, other adverse events | All Subjects | 474 | 962 |
| Total, serious adverse events | Lurasidone 20-80 mg Flexible Dose | 13 | 246 |
| Total, serious adverse events | Placebo | 11 | 250 |
| Total, serious adverse events | All Subjects | 41 | 962 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
GET https://conductscience.org/api/trials/v1/NCT01358357
GET https://conductscience.org/api/trials/v1/NCT01358357/results?page=2