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

March 31, 2014 updated by: Sunovion

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

505

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno - mesto, Czech Republic, 602 00
        • Psychiatricka ambulance
      • Litomerice, Czech Republic
        • BIALBI s.r.o., Psychiatricke Oddeleni
      • Praha, Czech Republic, 10 100 00
        • CLINTRIAL, s.r.o.
    • Praha
      • Kolejni 429-5, Praha, Czech Republic
        • Medical Services Prague s.r.o.
  • France
      • Nimes Cedex, France, 30 30029
        • Hopital Caremeau, Service de Psychiatrie A
      • Orvault, France, 44700
        • Zans Ritter, Marcel
  • India
    • Andh Prad
      • Tirupati, Andh Prad, India, 517507
        • S V Medical College
      • Vijaywada, Andh Prad, India, 520002
        • Vijayawada Institute of Mental Health and Neurosciences, Psychiatry
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • Samvedna Hospitals
      • Ahmedabad, Gujarat, India, 380006
        • Seth K M School of P G Medicine & Research
      • Ahmedabad, Gujarat, India, 380013
        • Mental Illness Treatment Rehabilitationi Foundation
    • Karna
      • Bangalore, Karna, India, 560010
        • Spandana Nursing Home
    • Mahara
      • Nashik, Mahara, India, 422101
        • Sujata Birla Hospital & Research Centre
    • Rajasthan
      • Jaipur, Rajasthan, India, 302021
        • R.K. Yadav Memorial Mental Health & De-Addiction Hospital
    • Uttar Prad
      • Lucknow, Uttar Prad, India, 226006
        • Manobal Med. Research Centre
  • Romania
      • Bucdresti, Romania, 010825
        • Spitalul Clinic de Urgenta Militar Central
      • Bucuresti, Romania, 041914
        • Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia
      • Cluj-Napoca, Romania, 400012
        • Spitalul Clinic Judetean de Urgenta Cluj
      • Craiova, Romania, 200620
        • Spitalul Clinic de Neuropsihiatrie Craiova
      • Oradea, Romania, 410154
        • Spitalul Clinic de Neurologie si Psihiatrie Oradea
  • Russian Federation
      • St. Petersburg, Russian Federation, 190121
        • City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
      • St. Petersburg, Russian Federation, 193019
        • Bekhterev Scientific Research Psychoneurological Institute
      • St. Petersburg, Russian Federation, 197110
        • Psychoneurology Dispensary #4
  • South Africa
      • Cape Town, W. Cape, South Africa, 7530
        • Cape Trial Centre
      • Paarl, W. Cape, South Africa, 7646
        • Paarl Medical Centre
      • Port Elizabeth, E. Cape, South Africa, 6000
        • Clinika
      • Pretoria, Gauteng, South Africa, 0181
        • Dey Clinic
      • Vereeniging, Free State, South Africa, 1941
        • Vereeniging Medi-Clinic
  • Ukraine
      • Donetsk, Ukraine, 83008
        • Chair of Psychiatry and Medical Psychology
      • Odessa, Ukraine
        • Reg. Psychiatric Hospital
      • Poltava, Ukraine, 36006
        • Reg Cl.Ps.H.n.a.O.F. Malstev, Fem.Ac. Gen. Ps.D.5B
      • Simferopol, Ukraine, 95006
        • CRI Cl.Psych.Hosp. #1, Fem. Psych. Dept. #2, Male I
      • Vinnitsia, Ukraine, 21018
        • Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21
  • United States
    • California
      • Escondido, California, United States, 92025
        • Synergy Escondido,710 East Grand Ave.
      • Garden Grove, California, United States, 92645
        • Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3
      • Oceanside, California, United States, 92056
        • Excell Research, Inc,3998 Vista Way,Suite 100
      • Orange, California, United States, 92868
        • University of California at Irvine Medical Center
      • Pico Rivera, California, United States, 90660
        • California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road
      • San Diego, California, United States, 92102
        • California Neuropsychopharmacology Clinical Research Institute, LLC,466 26th Street,6th Floor
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Florida
      • Bradenton, Florida, United States, 34208
        • Florida Clinical Research Center, LLC,3914 State Road 64 East
      • Maitland, Florida, United States, 32751
        • Florida Clinical Research Center, LLC,2300 Maitland Center Parkway,Suite 230
      • Tampa, Florida, United States, 33613
        • Depression and Anxiety Disorders Research Institute
      • West Palm Beach, Florida, United States, 33407
        • Janus Center for Psychiatric Research,5601 Corporate Way,Suite 103
    • Illinois
      • Oak Brook, Illinois, United States, 60523
        • American Medical Research Inc.,1200 Harger Road Suite 415
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340
    • Maryland
      • Baltimore, Maryland, United States, 21285
        • Sheppard Pratt Health System,6501 North Charles Street
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Albuquerque Neuroscience Inc., 101 Hospital Loop, NE, Suite 209
    • New York
      • Cedarhurst, New York, United States, 11516
        • Neurobehavioral Research, Inc.
      • Rochester, New York, United States, 14618
        • Finger Lakes Clinical Research
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Richard H. Weisler., M.D., P.A., & Associates,700 Spring Forest Road,Suite 125
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Mood Disorders Program-UHCMC
      • Cleveland, Ohio, United States, 44122
        • MetroHealth System
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • CRI Worldwide, LLC
    • Texas
      • Austin, Texas, United States, 78756
        • FutureSearch Clinical Trials, LLC.,4200 Marathon Blvd.,Suite 200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo Comparator
Experimental: lurasidone low arm
Drug: lurasidone
lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
Drug: lurasidone
lurasidone 20 mg/day for Days 1-7
Experimental: lurasidone high arm
Drug: lurasidone
lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
Drug: lurasidone
lurasidone 20 mg/day for Days 1-7

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)
Time Frame: Baseline to 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 Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
Time Frame: Baseline to 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 0 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.
Baseline to Week 6
Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
Time Frame: Baseline to Week 6

Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of depression.

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.
Baseline to Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunovion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

March 23, 2009

First Submitted That Met QC Criteria

March 24, 2009

First Posted (Estimate)

March 25, 2009

Study Record Updates

Last Update Posted (Estimate)

April 17, 2014

Last Update Submitted That Met QC Criteria

March 31, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1050236
  • EUDRACT No. 2008-007457-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bipolar Depression

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe