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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01284517
First received: January 25, 2011
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Bipolar Depression
Drug: Lurasidone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6) [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 356
Study Start Date: November 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lurasidone 20-120 mg flexible dose Drug: Lurasidone
Tablets 20-120 mg, PM dosing,daily for 6 weeks
Other Name: Latuda
Placebo Comparator: Placebo Drug: Placebo
Equivalent to Lurasidone dosing

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284517

  Show 75 Study Locations
Sponsors and Collaborators
Sunovion
Investigators
Study Director: Medical Director, MD Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01284517     History of Changes
Other Study ID Numbers: D1050292, 2010-019778-34
Study First Received: January 25, 2011
Results First Received: August 7, 2013
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
China: Ministry of Health
Colombia: National Institutes of Health
Czech Republic: State Institute for Drug Control
India: Drugs Controller General of India
Japan: Pharmaceuticals and Medical Devices Agency
Peru: Ministry of Health
Slovakia: State Institute for Drug Control
Ukraine: Ministry of Health

Keywords provided by Sunovion:
Bipolar I Depression
Lurasidone
Latuda

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014