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

March 31, 2014 updated by: Sunovion

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

348

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, 412 01
        • BIALBI s.r.o. Psychiatricke oddeleni
      • Praha, Czech Republic, 10 100 00
        • CLINTRIAL, s.r.o.
      • Praha, Czech Republic, 6 160 00
        • Medical Services Prague s.r.o.
      • Praha, Czech Republic, 9 190 00
        • Psychiatricka ambulance Prosek
  • France
      • Nimes Cedex, France, 30 30029
        • Hopital Caremeau, Service de Psychiatrie A
      • Orvault, France, 44700
        • Zans Ritter, Marcel
  • Germany
      • Berlin BE, Germany, 10245
        • Jana Thomsen
  • India
      • Delhi, India, 110092
        • Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry
    • Andh Prad
      • Tirupati, Andh Prad, India, 517507
        • SV 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
        • Sheth Vadilal Sarabhai General Hospital
      • Ahmedabad, Gujarat, India, 380013
        • Mental Illness Treatment Rehabilitation Foundation (MITR)
      • Junagadh, Gujarat, India, 362001
        • Shree Hatkesh Health 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
  • Poland
      • Chelmno, Poland, 86-200
        • ZOZ Poradnia Zdrowia Psychicznego
      • Skorzewo, Poland, 60-185
        • Praktyka Lekarska Sensorium S.M.O.
      • Warszawa, Poland, 03-242
        • Wojewodzki Szpital Brodnowski SP ZOZ
  • Romania
      • Bucuresti, Romania, 010825
        • Spitalul Clinic de Urgenta Militar Central "Prof. Dr. Carol" Psihiatrie
      • 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
      • Pitesti, Romania, 110069
        • Spitalul Judetean de Urgenta Pitesti Sectia de Psihiatric
  • Russian Federation
      • Moscow, Russian Federation, 117997
        • Russian State Medical University
      • Moscow, Russian Federation, 119435
        • Moscow Medical Academy named I.M. Sechenov
      • 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
      • St. Petersburg, Russian Federation, 198035
        • LLC International Medical Centre "SOGAZ"
  • 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
        • Reg. Clinic Psych. Hosp., Dept 11, DNMU n.a.M. Gorkiy
      • Odesa, Ukraine, 65014
        • Odesa Regional Psychoneurological Dispensary
      • Poltava, Ukraine, 36006
        • Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM
      • Simferopol, Ukraine, 95006
        • CRI"Cl. Psych.Hosp.#1, Fem Psych.Dept.#2, Male Psych.Dept.#1
      • Vinnitsia, Ukraine, 21005
        • Reg. Psych. Hosp. n.a. O.Yuschenko, Dept. #21, VNMUn.a.M. Pirog
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Woodland International Research Inc.
    • California
      • Anaheim, California, United States, 92804
        • South Coast Clinical Trials, Inc.
      • Chino, California, United States, 91710
        • Catalina Research Institute
      • Escondido, California, United States, 92025
        • Synergy Escondido
      • Garden Grove, California, United States, 92645
        • Collaborative Neuroscience Network Inc.,12772 Valley View Street
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Orange, California, United States, 92868
        • University of California at Irvine Medical Center
      • Pico Rivera, California, United States, 90660
        • CNRI - Los Angeles LLC,8309 Telegraph Road
      • San Diego, California, United States, 92102
        • CNRI - San Diego, LLC
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Florida
      • Tampa, Florida, United States, 33613
        • Depression and Anxiety Disorders Research Institue
    • Illinois
      • Oak Brook, Illinois, United States, 60523
        • American Medical Research Inc.,1200 Harger Road Suite 415
      • Oak Brook, Illinois, United States, 60523
        • American Medical Research, Inc., 1200 Harger Road Suite 415
    • Louisiana
      • Shreveport, Louisiana, United States, 71104
        • J. Gary Booker, Md
    • Maryland
      • Baltimore, Maryland, United States, 21285
        • Sheppard Pratt Health System,6501 North Charles Street
      • Rockville, Maryland, United States, 20852
        • Capital Clinical Research,5515 Security Lane, Suite 525
    • Missouri
      • St. Charles, Missouri, United States, 63301
        • Midwest Research GRoup
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Albuquerque Neuroscience Inc.,101 Hospital Loop, Suite 209
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Lake Charles Clinical Trials LLC,700 Spring Forest Road
      • Raleigh, North Carolina, United States, 27609
        • Richard H. Weisler , M.D., PA.,& Associates, 700 Spring Forest Road, Suite 125
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44106
        • Mood Disorders Program-UHCMC
      • Cleveland, Ohio, United States, 44122
        • MetroHealth System
      • Dayton, Ohio, United States, 45408
        • Midwest Clinical research Center, One Elizabeth Place, Suite G-3
    • 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
  • Subject must be taking lithium or divalproex at least 28 days prior to screening

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 + (lithium or divalproex)
20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
Experimental: Lurasidone
Drug: lurasidone + (lithium or divalproex)
lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 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, Week 6
MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Baseline, 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 Week 6
CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Baseline Week 6
Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
Time Frame: Baselin Week 6
STS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Baselin 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)

December 1, 2011

Study Completion (Actual)

January 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

  • D1050235
  • EUDRACT No. 2008-007482-23

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.

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