Bipolar DepressionPhase 3NCT01986101

A Phase III Study of SM-13496 in Patients With Bipolar I Depression.

A Phase 3 study testing SM-13496 in people with Bipolar Depression, run by Sumitomo Pharma Co., Ltd. at 8 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression. Read more about this study

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Bipolar Depression
What is being tested?: SM-13496
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 525 participants
Where: 8 sitesin 8 countries
Study dates: 19 Feb 2014to 16 Feb 2017
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 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 depressed (≥ 4 weeks and less than 12 months) without psychotic features.

Who cannot join

Patients with imminent risk of suicide or injury to self, others, or property.
Patients who had been hospitalized because of a manic or mixed episode within 60 days prior to screening.
Patients who are otherwise considered ineligible for the study by the investigator.

Trial locations and contacts

8 sites in 8 countries.

Country

City, postcode or hospital

8 sites in 8 countries

Japan1 site

Japan 76 sites
Tokyo

Other trials in Japan

Lithuania1 site

Lithuania 3 sites
Kaunas

Other trials in Lithuania

Malaysia1 site

Malaysia 5 sites
Kuala Lumpur

Other trials in Malaysia

Philippines1 site

Philippines 4 sites
Manila

Other trials in Philippines

Russia1 site

Russia 19 sites
Moscow

Other trials in Russia

Slovakia1 site

Slovakia 5 sites
Žilina

Other trials in Slovakia

Taiwan1 site

Taiwan 7 sites
Taipei

Other trials in Taiwan

Ukraine1 site

Ukraine 9 sites
Kiev

Other trials in Ukraine

About this study

Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression.

The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.

Read the detailed description

The primary objective is to compare the efficacy of SM-13496 (20-60 or 80-120 mg/day) monotherapy with that of placebo in patients with depressive symptoms associated with bipolar I disorder by assessing the change from baseline in the MADRS total score at Week 6.

Conditions: Bipolar Depression
Being tested: Placebo, SM-13496
Medical subject headings: Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Placebo comparator
SM-13496Drug
Also called Lurasidone HCl
SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6
SM-13496Drug
Also called Lurasidone HCl
SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6

Study groups in NCT01986101
Study group	Role	What they receive
Placebo	Placebo comparator	once daily orally Receives: Drug: Placebo
SM-13496 20 - 60 mg/day	Experimental	once daily orally Receives: Drug: SM-13496
SM-13496 80 - 120 mg/day	Experimental	once daily orally Receives: Drug: SM-13496

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6
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 to 6 weeks

Secondary outcomes (4)

Change From Baseline in the CGI-BP-S (Depression) Score at Week 6
Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression.
The CGI depression score ranges from a minimum of 1 to a maximum of 7. For the CGI depression 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.
Measured: Baseline to 6 weeks
Change From Baseline in the SDS Total Score at Week 6 (LOCF)
Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of functional impairment in work/school, social life and family life/home responsibilities.
The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS 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 SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items.
Measured: Baseline to 6 weeks
Change From Baseline in the YMRS Total Score at Week 6
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 to 6 weeks
Change From Baseline in the HAM-A Total Score at Week 6 (LOCF)
The Hamilton Rating Scale for Anxiety (HAM-A) scale is a rating scale developed to quantify the severity of anxiety symptomatology.
The HAM-A total score ranges from a minimum of 0 to a maximum of 56. For the HAM-A 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 HAM-A contains fourteen (14) items. The total score is computed as the sum of the scores for the 14 items.
Measured: Baseline to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Feb 201416 Feb 2017

First posted18 Nov 2013 (estimated)
Study start19 Feb 2014
Primary completion1 Feb 2017
Study completion16 Feb 2017

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 (4)Papers the sponsor has linked to this study.
Other trials for Bipolar DepressionStudies 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: 525 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01986101
Sponsor's protocol ID: D1002001
Other IDs: JapicCTI-132318, 2013-003038-34
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

Kato T, Ishigooka J, Miyajima M, Watabe K, Fujimori T, Masuda T, Higuchi T, Vieta E. Double-blind, placebo-controlled study of lurasidone monotherapy for the treatment of bipolar I depression. Psychiatry Clin Neurosci. 2020 Dec;74(12):635-644. doi: 10.1111/pcn.13137. Epub 2020 Sep 24.
PubMed 32827348
Hopkins SC, Tomioka S, Szabo ST, Koblan KS. A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression. Contemp Clin Trials. 2024 Oct;145:107644. doi: 10.1016/j.cct.2024.107644. Epub 2024 Aug 3.
PubMed 39098761
Kishi T, Nakamura H, Kato T, Iwata N. A diagnostic test to examine early improvement as a predictor of later response to lurasidone in bipolar depression. Neuropsychopharmacol Rep. 2023 Mar;43(1):137-140. doi: 10.1002/npr2.12319. Epub 2023 Jan 12.
PubMed 36632763
Kishi T, Yoshimura R, Sakuma K, Okuya M, Iwata N. Lurasidone, olanzapine, and quetiapine extended-release for bipolar depression: A systematic review and network meta-analysis of phase 3 trials in Japan. Neuropsychopharmacol Rep. 2020 Dec;40(4):417-422. doi: 10.1002/npr2.12137. Epub 2020 Sep 9.
PubMed 32902200

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bipolar Depression trials

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 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression.
ClinicalTrials.gov ID: NCT01986101
Acronym / sponsor ID: D1002001
Conditions: Bipolar Depression
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 525 participants (actual)
Lead sponsor: Sumitomo Pharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: 19 Feb 2014 (actual)
Primary completion: 1 Feb 2017 (actual)
Study completion: 16 Feb 2017 (actual)
First posted: 18 Nov 2013 (estimated)
Results: Posted 25 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 efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placeboonce daily orally
SM-13496 20 - 60 mg/day	Experimental	Drug: SM-13496once daily orally
SM-13496 80 - 120 mg/day	Experimental	Drug: SM-13496once daily orally

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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 depressed (≥ 4 weeks and less than 12 months) without psychotic features.

Key exclusion criteria (3 listed)

Patients with imminent risk of suicide or injury to self, others, or property.
Patients who had been hospitalized because of a manic or mixed episode within 60 days prior to screening.
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
PlaceboPlacebo comparator	Drug	Placebo
SM-13496Also: Lurasidone HClSM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6	Drug	SM-13496 20 - 60 mg/day
SM-13496Also: Lurasidone HClSM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6	Drug	SM-13496 80 - 120 mg/day

Primary outcome

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6
Time frame: Baseline to 6 weeks
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.

4 secondary outcomes

Change From Baseline in the CGI-BP-S (Depression) Score at Week 6
Time frame: Baseline to 6 weeks
Change From Baseline in the SDS Total Score at Week 6 (LOCF)
Time frame: Baseline to 6 weeks
Change From Baseline in the YMRS Total Score at Week 6
Time frame: Baseline to 6 weeks
Change From Baseline in the HAM-A Total Score at Week 6 (LOCF)
Time frame: Baseline to 6 weeks

Results and safety

Results posted to the registry on 25 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	172	139
SM-13496 20 - 60 mg/Day	184	157
SM-13496 80 - 120 mg/Day	169	137

Primary outcome: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6

Time frame: Baseline to 6 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 171	SM-13496 20 - 60 mg/Day n = 182	SM-13496 80 - 120 mg/Day n = 169
Value	-10.6 (0.72)	-13.6 (0.69)	-12.6 (0.73)

Placebo vs SM-13496 20 - 60 mg/Day: Mean Difference (Final Values): -2.9 (95% CI -4.9 to -1.0), p = 0.007, Mixed Models Analysis
Placebo vs SM-13496 80 - 120 mg/Day: Mean Difference (Final Values): -2.0 (95% CI -4.0 to 0.1), p = 0.057, Mixed Models Analysis

Population analysed: Intention-to-treat population is analyzed.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	5 of 172 (2.9%)	44 of 172 (25.6%)	0 of 172
SM-13496 20 - 60 mg/Day	2 of 184 (1.1%)	49 of 184 (26.6%)	0 of 184
SM-13496 80 - 120 mg/Day	4 of 169 (2.4%)	75 of 169 (44.4%)	0 of 169

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.
Results publication: PubMed 32827348Kato T, Ishigooka J, Miyajima M, Watabe K, Fujimori T, Masuda T, Higuchi T, Vieta E. Double-blind, placebo-controlled study of lurasidone monotherapy for the treatment of bipolar I depression. Psychiatry Clin Neurosci. 2020 Dec;74(12):635-644. doi: 10.1111/pcn.13137. Epub 2020 Sep 24.
Derived from this study: PubMed 39098761Hopkins SC, Tomioka S, Szabo ST, Koblan KS. A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression. Contemp Clin Trials. 2024 Oct;145:107644. doi: 10.1016/j.cct.2024.107644. Epub 2024 Aug 3.
Derived from this study: PubMed 36632763Kishi T, Nakamura H, Kato T, Iwata N. A diagnostic test to examine early improvement as a predictor of later response to lurasidone in bipolar depression. Neuropsychopharmacol Rep. 2023 Mar;43(1):137-140. doi: 10.1002/npr2.12319. Epub 2023 Jan 12.
Derived from this study: PubMed 32902200Kishi T, Yoshimura R, Sakuma K, Okuya M, Iwata N. Lurasidone, olanzapine, and quetiapine extended-release for bipolar depression: A systematic review and network meta-analysis of phase 3 trials in Japan. Neuropsychopharmacol Rep. 2020 Dec;40(4):417-422. doi: 10.1002/npr2.12137. Epub 2020 Sep 9.
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 Depression, 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 3 inclusion and 3 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. 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?

Yes. Results are posted in the registry (first posted 25 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?

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (time frame: Baseline to 6 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 NCT01986101, which also lists 4 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.