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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
348

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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