Bipolar I DisorderPhase 3NCT01986114
A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
A Phase 3 study testing SM-13496 in people with Bipolar I Disorder, run by Sumitomo Pharma Co., Ltd. at 8 sites in 8 countries.
Trial summary
The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Bipolar I Disorder
- What is being tested?
- SM-13496
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 8 sitesin 8 countries
- Study dates
- 29 Jan 2014to 17 Feb 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who completed the D1002001 study
- ・Patients who completed the D1002001 study and who are considered by the investigator to be eligible and without safety concerns.
- Patients who did not participate in the D1002001 study
- Patients who were fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provided written voluntary consent to participate in the study.
- Outpatients aged 18 through 74 years at the time of consent
- Patients meets DSM-IV-TR criteria for bipolar I disorder, most recent episode manic, hypomanic, or mixed with or without rapid cycling disease course (≥ 4 episodes of mood disturbance, but < 8 episodes in the previous 12 months prior to screening).
Who cannot join
- Patients with imminent risk of suicide or injury to self, others, or property.
- Patients who are otherwise considered ineligible for the study by the investigator.
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
About this study
The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.
Read the detailed description
The study objective is to evaluate the long-term efficacy and safety of SM-13496 (20-120 mg/day) in patients with bipolar I disorder.
- Conditions
- Bipolar I Disorder
- Being tested
- SM-13496
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM-13496Drug
Also called Lurasidone
| Study group | Role | What they receive |
|---|---|---|
| SM-13496 20-120mg | Experimental | once daily orally SM-13496 20-120 mg flexibly dosed Receives: Drug: SM-13496 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR)
The number and percentage of subjects with at least one adverse event and adverse drug reaction
Measured: 28, 52 weeks
Secondary outcomes (3)
Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
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.
Measured: Baseline, 52 weeks and each month
Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score.
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.
Measured: Baseline, 52 weeks and each month
Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder.
The number and percentage of subjects who experienced recurrence/relapse of any mood event from clinical stability of bipolar disorder.
Measured: Baseline to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study start29 Jan 2014
- Primary completion8 Feb 2018
- Study completion17 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar I DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director, Drug Development Division, Study director, Sumitomo Pharma Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986114
- Sponsor's protocol ID
- D1002002
- Other IDs
- JapicCTI-132319, 2013-003039-31
- Status last verified
- Apr 2022
- First submitted
- 4 Nov 2013
- Last updated
- 12 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Higuchi T, Kato T, Miyajima M, Watabe K, Masuda T, Hagi K, Ishigooka J. Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study. Int J Bipolar Disord. 2021 Aug 2;9(1):25. doi: 10.1186/s40345-021-00230-8.
PubMed 34342746Ishigooka J, Kato T, Miyajima M, Watabe K, Masuda T, Hagi K, Higuchi T. Lurasidone in the Long-Term Treatment of Bipolar I Depression: A 28-week Open Label Extension Study. J Affect Disord. 2021 Feb 15;281:160-167. doi: 10.1016/j.jad.2020.12.005. Epub 2020 Dec 8.
PubMed 33321381
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
- ClinicalTrials.gov ID
- NCT01986114
- Acronym / sponsor ID
- D1002002
- Conditions
- Bipolar I Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 495 participants (actual)
- Lead sponsor
- Sumitomo Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jan 2014 (actual)
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 17 Feb 2018 (actual)
- First posted
- 18 Nov 2013 (estimated)
- Results
- Posted 23 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.
Detailed description
The study objective is to evaluate the long-term efficacy and safety of SM-13496 (20-120 mg/day) in patients with bipolar I disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SM-13496 20-120mg | Experimental | Drug: SM-13496once daily orally SM-13496 20-120 mg flexibly dosed |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who completed the D1002001 study
- ・Patients who completed the D1002001 study and who are considered by the investigator to be eligible and without safety concerns.
- Patients who did not participate in the D1002001 study
- Patients who were fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provided written voluntary consent to participate in the study.
- Outpatients aged 18 through 74 years at the time of consent
Key exclusion criteria (2 listed)
- Patients with imminent risk of suicide or injury to self, others, or property.
- Patients who are otherwise considered ineligible for the study by the investigator.
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 |
|---|---|---|
| SM-13496Also: Lurasidone | Drug | SM-13496 20-120mg |
Primary outcome
Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR)
Time frame: 28, 52 weeks
The number and percentage of subjects with at least one adverse event and adverse drug reaction
3 secondary outcomes
Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
Time frame: Baseline, 52 weeks and each month
Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score.
Time frame: Baseline, 52 weeks and each month
Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder.
Time frame: Baseline to 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34342746Higuchi T, Kato T, Miyajima M, Watabe K, Masuda T, Hagi K, Ishigooka J. Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study. Int J Bipolar Disord. 2021 Aug 2;9(1):25. doi: 10.1186/s40345-021-00230-8.
- Derived from this study: PubMed 33321381Ishigooka J, Kato T, Miyajima M, Watabe K, Masuda T, Hagi K, Higuchi T. Lurasidone in the Long-Term Treatment of Bipolar I Depression: A 28-week Open Label Extension Study. J Affect Disord. 2021 Feb 15;281:160-167. doi: 10.1016/j.jad.2020.12.005. Epub 2020 Dec 8.
- Individual participant dataSharing planned: Undecided
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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.
Director, Drug Development Division study director
Sumitomo Pharma Co., Ltd.
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SM-13496 in people with Bipolar I Disorder, run by Sumitomo Pharma Co., Ltd. at 8 sites in 8 countries.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan, Lithuania, Malaysia, Philippines, Russia and 3 more countries. 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. 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?
Yes. Results are posted in the registry (first posted 23 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR) (time frame: 28, 52 weeks). 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 NCT01986114, which also lists 2 linked publications.
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 12 Apr 2022.