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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01358357




Registration number
NCT01358357
Ethics application status
Date submitted
19/05/2011
Date registered
23/05/2011
Date last updated
7/09/2016

Titles & IDs
Public title
Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex
Scientific title
A Randomized, Double-blind, Placebo-controlled, Flexible-dose, Parallel-group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Prevention of Recurrence in Subjects With Bipolar I Disorder
Secondary ID [1] 0 0
2011-000986-10
Secondary ID [2] 0 0
D1050296
Universal Trial Number (UTN)
Trial acronym
PERSIST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar I Disorder 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lurasidone
Treatment: Drugs - Placebo

Experimental: Lurasidone 20-80 mg flexible dose -

Placebo comparator: Placebo -


Treatment: Drugs: Lurasidone
Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter

Treatment: Drugs: Placebo
20-80 mg flexible dose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Recurrence of Mood Event During the Double Blind Treatment Phase
Timepoint [1] 0 0
28 weeks (up to 33 weeks)
Secondary outcome [1] 0 0
Time to All-cause Discontinuation
Timepoint [1] 0 0
28 weeks (up to 33 weeks)
Secondary outcome [2] 0 0
Time to Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode
Timepoint [2] 0 0
28 weeks (up to 33 weeks)
Secondary outcome [3] 0 0
Percentage of Subjects Who Experience a Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode
Timepoint [3] 0 0
28 weeks
Secondary outcome [4] 0 0
Change From Double-blind Baseline to Week 28 (LOCF) in CGI-BP-S Overall Score
Timepoint [4] 0 0
Double-blind Baseline to week 28
Secondary outcome [5] 0 0
Change From Double -Blind Baseline to Week 28 (LOCF) in CGI-BP-S Mania Score
Timepoint [5] 0 0
Double-blind Baseline to week 28
Secondary outcome [6] 0 0
Change From Double-blind Baseline to Week 28 (LOCF) in CGI+-BP-S Depression Score
Timepoint [6] 0 0
Double-blind Baseline to week 28
Secondary outcome [7] 0 0
Change From Double-blind Baseline to Week 28 (LOCF) in YMRS Total Score
Timepoint [7] 0 0
Double-blind Baseline to week 28
Secondary outcome [8] 0 0
Change From Double-blind Baseline to Week 28 (LOCF) in MADRS Total Score
Timepoint [8] 0 0
Double-blind Baseline to week 28
Secondary outcome [9] 0 0
Change Fro Double-blind Baseline to Week 28 (LOCF) in QIDS-SR(16) Total Score
Timepoint [9] 0 0
Double-blind Baseline to week 28
Secondary outcome [10] 0 0
Change From Double-blind Baseline to Week 28 (LOF) in PANSS Positive Symptom (PANNS-P) Subscale Score
Timepoint [10] 0 0
Double-blind Baseline to week 28
Secondary outcome [11] 0 0
Change From Double-blind Baseline to Week 28 (LOCF) in SDS Total Score
Timepoint [11] 0 0
Double-blind Baseline to week 28
Secondary outcome [12] 0 0
Change From Double-blind Baseline to Week 28 (LOCF) in PIRS-2 Total Score
Timepoint [12] 0 0
Double-blind Baseline to week 28
Secondary outcome [13] 0 0
Change From Double-blind Baseline to Week 28 (LOCF) in Q-LES-Q-SF Percent Maximum Possible Score
Timepoint [13] 0 0
Double-blind Baseline to week 28

Eligibility
Key inclusion criteria
Open-label Phase

* 18 years of age or older
* Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision (DSM-IV-TR) diagnosis of bipolar I disorder

•= 1 manic, mixed manic, or depressed episode in past 2 years
* YMRS or MADRS total score = 14 if on lithium or divalproex; = 18 if not on lithium or divalproex

Double-blind Phase



* Subjects must achieve consistent clinical stability, defined as total scores = 12 on the YMRS and MADRS over at least 12 weeks, with the allowance of two excursions (YMRS and/or MADRS total scores up to 13 or 14, respectively) except during the last 4 weeks before randomization
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Open Label Phase

* Diagnosis of an Axis I or Axis II disorder, other than bipolar I disorder, that is the primary focus of treatment within 3 months of screening
* Subjects for whom diagnostic agreement between the Investigator and United BioSource Corporation (Boston) (UBC) cannot be reached
* Ultra-fast rapid cycling (defined as = 8 mood episodes over the previous 12-month period)
* Subjects who test positive for drugs of abuse at screening. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from cannabis during the study
* Unstable/inadequately treated medical illness
* The subjects answers "yes" to "Suicidal Ideation" items 4 or 5 on the C-SSRS (at time of evaluation)

Double Blind Phase

* Subjects who in the Investigator's judgment have not been compliant with study medication during the stabilization phase
* Subjects who have not stabilized during the open-label phase (within 20 weeks)
* Subjects who test positive for drugs of abuse at double-blind phase baseline. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from cannabis during the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
Accrual to date
Final
965
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
The Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [2] 0 0
RWF Medic Pty Ltd as Trustee for Farnbach Family Trust at Neurotherapy Victoria - Malvern
Recruitment hospital [3] 0 0
The Melbourne Clinic - Richmond
Recruitment hospital [4] 0 0
Hollywood Medical Centre - Fremantle
Recruitment postcode(s) [1] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment postcode(s) [3] 0 0
3121 - Richmond
Recruitment postcode(s) [4] 0 0
6160 - Fremantle
Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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California
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Florida
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Georgia
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Indiana
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Massachusetts
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Missouri
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New York
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Ohio
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Oklahoma
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Argentina
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Provincia de Cordoba
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Argentina
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Santa Fe
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Buenos Aires
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Cordoba
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Argentina
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La Plata
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Argentina
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Mendoza
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Bulgaria
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Bourgas
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Bulgaria
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Plovdiv
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Bulgaria
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Rousse
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Chile
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Santiago
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Croatia
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Rijeka
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Croatia
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Zagreb
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Croatia
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Zagreg
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Czech Republic
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Brno-Bohunice
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Brno
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Pisek
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Prague 8-Bohunice
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Prague
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Praha 10
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Praha 4
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Prerov
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Czech Republic
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Usti nad labem
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France
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Dijon cedex
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France
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Dole
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France
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Montpellier Cedex 5
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Nimes Cedex 09
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Budapest
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Gyor
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Gyula
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Gunma
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Hokkaido
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Nagano
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Osaka
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Saga
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Tokyo
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Aichi
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Hachioji, Tokyo
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Kumamoto
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Okinawa
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Toyama
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Gdynia
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Kielce
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Torun
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Tuszyn
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Poland
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Wroclaw
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Russian Federation
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Izhevsk
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Nis
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Serbia
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Novi Knezevac
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Slovakia
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Rimavska Sobota
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Slovakia
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Zlate Moravce

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sumitomo Pharma America, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psychotic features.
Trial website
https://clinicaltrials.gov/study/NCT01358357
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director, MD
Address 0 0
Sumitomo Pharma America, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01358357