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Completed

NCT Number: NCT00868699

Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)

This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression

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Key information

Conditions

Bipolar Depression Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Depression Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical Services Prague s.r.o., Kolejni 429-5, Prague, Czechia

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Who can participate

Healthy volunteers accepted: No

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

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

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

Treatment and study plan

Lurasidone

Drug

lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day

Placebo

Drug

Placebo Comparator

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

    Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression.

    The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.

    The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items.

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

    Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression.

    The CGI depression score ranges from a minimum of 0 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.

  2. Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score

    Time frame: Baseline to Week 6

    Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of depression.

    The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.

    The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items.

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma America, Inc.

Industry

Registry information

Official study title

A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 25, 2009
Registry last updated
Apr 17, 2014

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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