Completed PHASE3 INTERVENTIONAL 2-arm NCT00868452

Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)

A Randomized, 6-Week, Double-Blind, Placebo- Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression

Sponsor: Sumitomo Pharma America, Inc.

Conditions Bipolar Depression

Interventions Placebo + (lithium or divalproex) lurasidone + (lithium or divalproex)

Updated 10 times since 2017 Last updated: Mar 31, 2014 Started: Apr 30, 2009 Primary completion: Dec 31, 2011 Completion: Jan 31, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Bipolar Depression and is currently completed. Sumitomo Pharma America, Inc. leads this study, which shows 10 recorded versions since 2009 — indicating substantial longitudinal coverage. This study adds to the longitudinal dataset for psychiatric treatment development.

Status Flow

Change History

10 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Sep 2023 — Jul 2024 [monthly]

Completed PHASE3
Jan 2023 — Sep 2023 [monthly]

Completed PHASE3

▶ Show 5 earlier versions

Dec 2022 — Jan 2023 [monthly]

Completed PHASE3
Jan 2021 — Dec 2022 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Apr 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Sumitomo Pharma America, Inc.

Data source: Sumitomo Pharma America, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ahmedabad, India , Albuquerque, United States , Anaheim, United States , Aurora, United States , Austin, United States , Baltimore, United States , Bangalore, India , Berlin BE, Germany , Brno - Mesto, Czechia , Bucharest, Romania and 49 more locations