Trial · NCT01986114
A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
NCT01986114, Phase 3, Completed, Sumitomo Pharma Co., Ltd.; results first posted 2019-07-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder. Trials, record NCT01986114. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01986114
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
- NCT number
- NCT01986114
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 495 participants, actual
- Lead sponsor
- Sumitomo Pharma Co., Ltd.
- Conditions
- Bipolar I Disorder
- Interventions
- SM-13496
- First posted
- 2013-11-18
- Last updated
- 2022-04-12
- Other registries' IDs
- eudract:2013-003039-31
- Results first posted
- 2019-07-23
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR) | 28, 52 weeks | The number and percentage of subjects with at least one adverse event and adverse drug reaction |
| Secondary | Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | Baseline, 52 weeks and each month | Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items. |
| Secondary | Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score. | Baseline, 52 weeks and each month | YMRS (Young Mania Rating Scale) is a clinician-rated assessment of the severity of mania in subjects with a diagnosis of bipolar disorder. The YMRS total score ranges from a minimum of 0 to a maximum of 60. For the YMRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The YMRS contains eleven (11) items. The total score is computed as the sum of the scores for the 11 items. |
| Secondary | Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder. | Baseline to 52 weeks | The number and percentage of subjects who experienced recurrence/relapse of any mood event from clinical stability of bipolar disorder. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR) | 28, 52 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | Baseline, 52 weeks and each month | units on a scale | MEAN | |
| SECONDARY | Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score. | Baseline, 52 weeks and each month | units on a scale | MEAN | |
| SECONDARY | Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder. | Baseline to 52 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR) | SM-13496 20-120mg (Overall, 28 Weeks) | 352 | Participants | ||
| Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR) | SM-13496 20-120mg (Japan, 52 Weeks) | 169 | Participants | ||
| Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | SM-13496 20-120mg (Overall, 28 Weeks) | -4.4 | Standard Deviation 12.09 | units on a scale | |
| Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | SM-13496 20-120mg (Japan, 52 Weeks) | 1.1 | Standard Deviation 12.58 | units on a scale | |
| Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score. | SM-13496 20-120mg (Overall, 28 Weeks) | -1.0 | Standard Deviation 4.54 | units on a scale | |
| Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score. | SM-13496 20-120mg (Japan, 52 Weeks) | -2.0 | Standard Deviation 6.73 | units on a scale | |
| Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder. | SM-13496 20-120mg (Overall, 28 Weeks) | 14 | Participants | ||
| Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder. | SM-13496 20-120mg (Japan, 52 Weeks) | 18 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SM-13496 20-120mg | 495 | |
| Overall Study | COMPLETED | SM-13496 20-120mg | 339 | |
| Overall Study | NOT COMPLETED | SM-13496 20-120mg | 156 |
Source ClinicalTrials.gov
Adverse events58
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 | SM-13496 20-120mg (Overall, 28 Weeks) | 14 | 495 | 15 |
| other | Diarrhoea | Gastrointestinal disorders | SM-13496 20-120mg (Japan, 52 Weeks) | 10 | 199 | 11 |
| other | Nausea | Gastrointestinal disorders | SM-13496 20-120mg (Overall, 28 Weeks) | 35 | 495 | 38 |
| other | Nausea | Gastrointestinal disorders | SM-13496 20-120mg (Japan, 52 Weeks) | 24 | 199 | 25 |
| other | Vomiting | Gastrointestinal disorders | SM-13496 20-120mg (Overall, 28 Weeks) | 17 | 495 | 21 |
| other | Vomiting | Gastrointestinal disorders | SM-13496 20-120mg (Japan, 52 Weeks) | 13 | 199 | 13 |
| other | Disease progression | General disorders | SM-13496 20-120mg (Overall, 28 Weeks) | 16 | 495 | 17 |
| other | Disease progression | General disorders | SM-13496 20-120mg (Japan, 52 Weeks) | 10 | 199 | 11 |
| other | Nasopharyngitis | Infections and infestations | SM-13496 20-120mg (Overall, 28 Weeks) | 51 | 495 | 63 |
| other | Nasopharyngitis | Infections and infestations | SM-13496 20-120mg (Japan, 52 Weeks) | 53 | 199 | 72 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SM-13496 20-120mg (Overall, 28 Weeks) | 0 | 495 |
| Total, all-cause mortality | SM-13496 20-120mg (Japan, 52 Weeks) | 0 | 199 |
| Total, other adverse events | SM-13496 20-120mg (Overall, 28 Weeks) | 250 | 495 |
| Total, other adverse events | SM-13496 20-120mg (Japan, 52 Weeks) | 137 | 199 |
| Total, serious adverse events | SM-13496 20-120mg (Overall, 28 Weeks) | 19 | 495 |
| Total, serious adverse events | SM-13496 20-120mg (Japan, 52 Weeks) | 12 | 199 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SM-13496 20-120mg (Overall, 28 Weeks) vs SM-13496 20-120mg (Japan, 52 Weeks): Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder. | Trial comparisons |
| SM-13496 20-120mg (Overall, 28 Weeks) vs SM-13496 20-120mg (Japan, 52 Weeks): Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR) | Trial comparisons |
| SM-13496 20-120mg (Overall, 28 Weeks) vs SM-13496 20-120mg (Japan, 52 Weeks): deaths from any cause | Trial comparisons |
| SM-13496 20-120mg (Overall, 28 Weeks) vs SM-13496 20-120mg (Japan, 52 Weeks): serious adverse events | Trial comparisons |
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/NCT01986114
GET https://conductscience.org/api/trials/v1/NCT01986114/events?page=2