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

NCT01986101 | Completed Phase 3 Results

• 3 other identifiers: D1002001JapicCTI-1323182013-003038-34
• Study Type: interventional
• Target: 525
• Locations: 8 countries
• Sites: 8

Brief Summary

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

Conditions

Bipolar Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 6 weeks

Secondary Outcomes (4)

• Change From Baseline in the CGI-BP-S (Depression) Score at Week 6

  Baseline to 6 weeks

• Change From Baseline in the SDS Total Score at Week 6 (LOCF)

  Baseline to 6 weeks

• Change From Baseline in the YMRS Total Score at Week 6

  Baseline to 6 weeks

• Change From Baseline in the HAM-A Total Score at Week 6 (LOCF)

  Baseline to 6 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

once daily orally

Drug: Placebo

SM-13496 20 - 60 mg/day

EXPERIMENTAL

once daily orally

Drug: SM-13496

SM-13496 80 - 120 mg/day

EXPERIMENTAL

once daily orally

Drug: SM-13496

Interventions

Placebo DRUG

Placebo comparator

Placebo

SM-13496 DRUG

SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6

Also known as: Lurasidone HCl

SM-13496 20 - 60 mg/day

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sumitomo Pharma Co., Ltd.: lead

Study Sites (8)

Japan 76 sites

Tokyo, Japan

Location

Lithuania 3 sites

Kaunas, Lithuania

Location

Malaysia 5 sites

Kuala Lumpur, Malaysia

Location

Philippines 4 sites

Manila, Philippines

Location

Russia 19 sites

Moscow, Russia

Location

Slovakia 5 sites

Žilina, Slovakia

Location

Taiwan 7 sites

Taipei, Taiwan

Location

Ukraine 9 sites

Kiev, Ukraine

Location

Related Publications (4)

• 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.

  PMID: 32827348 RESULT

• 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.

  PMID: 39098761 DERIVED

• 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.

  PMID: 36632763 DERIVED

• 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.

  PMID: 32902200 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic 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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 18, 2013
• Study Start: February 19, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 16, 2017
• Last Updated: April 12, 2022
• Results First Posted: July 25, 2019

Record last verified: 2022-04

Locations

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