NCT01986114

Brief Summary

The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
495

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2014

Typical duration for phase_3

Geographic Reach
8 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 29, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2018

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

July 23, 2019

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

4 years

First QC Date

November 4, 2013

Results QC Date

May 19, 2019

Last Update Submit

April 9, 2022

Conditions

Bipolar I Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

    28, 52 weeks

Secondary Outcomes (3)

  • Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score

    Baseline, 52 weeks and each month

  • Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score.

    Baseline, 52 weeks and each month

  • Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder.

    Baseline to 52 weeks

Study Arms (1)

SM-13496 20-120mg

EXPERIMENTAL

once daily orally SM-13496 20-120 mg flexibly dosed

Drug: SM-13496

Interventions

SM-13496DRUG
Also known as: Lurasidone
SM-13496 20-120mg

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Japan 68 sites

Tokyo, Japan

Location

Lithuania 3 sites

Kaunas, Lithuania

Location

Malaysia 5 sites

Kuala Lumpur, Malaysia

Location

Philippines 5 sites

Manila, Philippines

Location

Russia 19 sites

Moscow, Russia

Location

Slovakia 5 sites

Žilina, Slovakia

Location

Taiwan 8 sites

Taipei, Taiwan

Location

Ukraine 9 sites

Kiev, Ukraine

Location

Related Publications (2)

  • 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.

    PMID: 34342746DERIVED

  • Ishigooka 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.

    PMID: 33321381DERIVED

MeSH Terms

Interventions

Lurasidone Hydrochloride

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Clinical Research
Organization
Sumitomo Dainippon Pharmaceutical
cc@ds-pharma.co.jp
+81-3-5159-2519

Study Officials

  • Director, Drug Development Division

    Sumitomo Pharma Co., Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2013

First Posted

November 18, 2013

Study Start

January 29, 2014

Primary Completion

February 8, 2018

Study Completion

February 17, 2018

Last Updated

April 12, 2022

Results First Posted

July 23, 2019

Record last verified: 2022-04

Locations

SL(1)PH(1)UA(1)LI(1)MY(1)RU(1)JP(1)TW(1)