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Completed

NCT Number: NCT01284517

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

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.

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Key information

Conditions

Bipolar Depression Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Group Edmonton Inc, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
  • Any chronic organic disease of the CNS (other than Bipolar I Disorder).
  • Hospitalization for a manic or mixed episode within the past two months.
  • Used investigational compound within past 6 months.
  • Clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.

Treatment and study plan

Lurasidone

Drug

Tablets 20-120 mg, PM dosing,daily for 6 weeks

Other names: Latuda

Placebo

Drug

Equivalent to Lurasidone dosing

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma America, Inc.

Industry

Registry information

Official study 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.

Acronym: PREVAIL3

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2011
Registry last updated
Nov 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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