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Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression

NCT00868699•Sumitomo Pharma America, Inc.

View on ClinicalTrials.gov

Summary

This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject is diagnosed with bipolar I disorder, most resent episode depressed
•Subject must have a lifetime history of at least one bipolar manic or mixed episode

Exclusion Criteria

•History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode
•Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization
•Imminent risk of suicide or injury to self, others, or property

Locations (55)

Synergy Escondido,710 East Grand Ave.

Escondido, California, United States

Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3

Garden Grove, California, United States

Excell Research, Inc,3998 Vista Way,Suite 100

Oceanside, California, United States

University of California at Irvine Medical Center

Orange, California, United States

California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road

Pico Rivera, California, United States

California Neuropsychopharmacology Clinical Research Institute, LLC,466 26th Street,6th Floor

San Diego, California, United States

University of Colorado

Aurora, Colorado, United States

Florida Clinical Research Center, LLC,3914 State Road 64 East

Bradenton, Florida, United States

Florida Clinical Research Center, LLC,2300 Maitland Center Parkway,Suite 230

Maitland, Florida, United States

Depression and Anxiety Disorders Research Institute

Tampa, Florida, United States

Key Dates

Start Date

April 1, 2009

Primary Completion Date

February 1, 2012

Completion Date

February 1, 2012

Last Updated

April 17, 2014

Enrollment

505

ACTUAL participants

Conditions

Bipolar Depression

Interventions

lurasidone

DRUG

lurasidone

DRUG

Placebo

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITINGNA

Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression

NCT06524505

Bipolar Depression

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure

HD-tDCS for Adolescent Bipolar Depression Targeting S1

Delivering Electronic Cognitive Behavioural Therapy to Patients With Bipolar Disorder and Residual Depressive Symptoms