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Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression (PREVAIL3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01284517
Recruitment Status : Completed
First Posted : January 27, 2011
Results First Posted : October 14, 2013
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
Sunovion

Tracking Information
First Submitted Date  ICMJE January 25, 2011
First Posted Date  ICMJE January 27, 2011
Results First Submitted Date  ICMJE August 7, 2013
Results First Posted Date  ICMJE October 14, 2013
Last Update Posted Date November 26, 2013
Study Start Date  ICMJE November 2010
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2013)
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6) [ Time Frame: Baseline to 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2011)
  • Mean change from baseline in MADRS total score after 6 weeks of treatments [ Time Frame: 6 weeks ]
  • Proportions of subjects with Adverse Events, discontinuations due to Adverse Events and Serious Adverse Events [ Time Frame: 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2013)
  • 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 ]
    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.
  • Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score [ Time Frame: Baseline to week 6 ]
    SDS 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2011)
  • Global severity assessed by the CGI-BP-S score (depression) [ Time Frame: 6 weeks ]
  • Functional impairment assessed by the Sheehan Disability Scale (SDS) total score [ Time Frame: 6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
Official Title  ICMJE 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 in Subjects Demonstrating Non-response to Treatment With Lithium or Divalproex Alone.
Brief Summary Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Depression
Intervention  ICMJE
  • Drug: Lurasidone
    Tablets 20-120 mg, PM dosing,daily for 6 weeks
    Other Name: Latuda
  • Drug: Placebo
    Equivalent to Lurasidone dosing
Study Arms  ICMJE
  • Experimental: Lurasidone 20-120 mg flexible dose
    Intervention: Drug: Lurasidone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Suppes T, Kroger H, Pikalov A, Loebel A. Lurasidone adjunctive with lithium or valproate for bipolar depression: A placebo-controlled trial utilizing prospective and retrospective enrolment cohorts. J Psychiatr Res. 2016 Jul;78:86-93. doi: 10.1016/j.jpsychires.2016.03.012. Epub 2016 Mar 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2013)
356
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2011)
340
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Provide written informed consent and is 18 to 75 years of age inclusive.
  2. Meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features.
  3. Has a lifetime history of at least one bipolar manic or mixed manic episode.
  4. Currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex.
  5. Not pregnant or nursing and is not planning pregnancy within the projected duration of the study.
  6. Females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after
  7. Good physical health on the basis of medical history, physical examination, and laboratory screening.

Exclusion Criteria:

  1. Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
  2. Any chronic organic disease of the CNS (other than Bipolar I Disorder).
  3. Hospitalization for a manic or mixed episode within the past two months.
  4. Used investigational compound within past 6 months.
  5. Clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Colombia,   Czech Republic,   India,   Japan,   Lithuania,   Peru,   Slovakia,   Ukraine,   United States
Removed Location Countries China
 
Administrative Information
NCT Number  ICMJE NCT01284517
Other Study ID Numbers  ICMJE D1050292
2010-019778-34 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sunovion
Study Sponsor  ICMJE Sunovion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director, MD Sunovion
PRS Account Sunovion
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP