Skip to main content
OpenTrials
Completed

NCT Number: NCT00868959

Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression

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

Completed

Looking for future studies?

Notify Me

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

Clinical Research Group Edmonton, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is judged by the investigator to be suitable for participation in a 24-week clinical trial involving open-label lurasidone treatment
  • Subject has completed the 6-week treatment period and all required assessments on the final study visit (Day 42, Visit 8) of either Study D1050235, NCT#00868452 or Study D1050236, NCT#008668699.

Exclusion criteria

  • Imminent risk of suicide, injury to self or to others, or damage to property
  • Subject has evidence of severe movement disorders.
  • Subject tests positive for drugs of abuse (at Visit 8 in Study D1050235, NCT#00868452 or D1050236, NCT#008688699).

Treatment and study plan

Lurasidone

Drug

Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks

Primary outcomes

  1. Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment

    Time frame: 24 weeks

    Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235 (NCT00868452), Study D1050236 (NCT00868699) or Study D1050292 (NCT01284517)

Secondary outcomes

  1. Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

    Time frame: 24 weeks

    The MADRS is a clinician-rated assessment of the subject's level of depression. Ten items are rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of ten items: reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.

  2. Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)

    Time frame: 24 weeks

    This CGI-BP-S is a clinician-rated assessment of the subjects current severity of depression and ranges from 1="Normal, not ill" to 7="Very severly ill". Higher scores are associated with greater severity.

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma America, Inc.

Industry

Registry information

Official study title

A 24-Week, Flexible-Dose, Open-Label Extension Study of Lurasidone for the Treatment of Bipolar I Depression

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 25, 2009
Registry last updated
Apr 14, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.