This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296 - Full Text View

Purpose

This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296

Condition	Intervention	Phase
Bipolar I Disorder	Drug: Lurasidone	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multi-center, Open Label, Flexible Dose, Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects With Bipolar I Disorder

Resource links provided by NLM:

Drug Information available for: Lurasidone

U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome Measures:

Treatment-emergent adverse events and treatment-emergent adverse events leading to discontinuation and serious adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Treatment-emergent adverse events and treatment-emergent adverse events leading to discontinuation and serious adverse events

Secondary Outcome Measures:

Physical examination - general appearance, head, eyes, ears/nose/throat, neck, lymph nodes, skin, lungs, heart, abdomen, musculoskeletal, and neurologic evaluations. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Physical examination - general appearance, head, eyes, ears/nose/throat, neck, lymph nodes, skin, lungs, heart, abdomen, musculoskeletal, and neurologic evaluations.
Weight - Body Mass Index (BMI) will be calculated in kg/m2. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Weight - Body Mass Index (BMI) will be calculated in kg/m2.
Colombia Suicide Severity Rating Scale C-SSRS [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Colombia Suicide Severity Rating Scale C-SSRS
Movement disorders assessed by Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Movement disorders assessed by Abnormal Involuntary Movement Scale (AIMS)
Young Mania Rating Scale (YMRS) total score Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Young Mania Rating Scale (YMRS) total score Montgomery-Asberg Depression Rating Scale (MADRS) total score
Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) total score
Positive and Negative Syndrome Scale Positive Subscale (PANSS P) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Positive and Negative Syndrome Scale Positive Subscale (PANSS P) score
Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (overall, depression, mania) Sheehan Disability Scale (SDS) total score and SDS subscales [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (overall, depression, mania) Sheehan Disability Scale (SDS) total score and SDS subscales
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
Pittsburgh Insomnia Rating Scale (PIRS-2) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Pittsburgh Insomnia Rating Scale (PIRS-2)
Health Services Utilization Questionnaire (HSUQ) (US sites only) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Health Services Utilization Questionnaire (HSUQ) (US sites only)
SF-12 Health Survey [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
SF-12 Health Survey
Medication Satisfaction Questionnaire (MSQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Medication Satisfaction Questionnaire (MSQ)
Intend to attend assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Intend to attend assessment
Laboratory measures [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Blood Chemistry Tests, Endocrine Tests, Hematology Tests, Urinalysis Tests, Urine Drug Screen
Vital Signs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Orthostatic changes in blood pressure and heart rate, blood pressure, pulse, respiratory rate, and temperature
Electrocardiogram [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
12-lead ECG
Movement disorders assessed by Barnes Akathisia Rating Scale (BARS) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Movement disorders assessed by Barnes Akathisia Rating Scale (BARS)
Movement disorders as assessed by Simpson-Angus Scale (SAS) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Movement disorders as assessed by Simpson-Angus Scale (SAS)
Mania as assessed by Young Mania Rating Scale (YMRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Movement disorders as assessed by Young Mania Rating Scale (YMRS)
Depression as assessed by Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Depression as assessed by Montgomery-Asberg Depression Rating Scale (MADRS)
Severity of illness as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Severity of illness as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S)
Functionality as assessed by Sheehan Disability Scale (SDS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Functionality as assessed by Sheehan Disability Scale (SDS)

Estimated Enrollment:	500
Study Start Date:	April 2012
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lurasidone Lurasidone 20, 40, 60,80 mg flexible dose	Drug: Lurasidone Lurasidone 20-80 mg taken orally once daily

Detailed Description:

To evaluate the longer term safety of lurasidone (20, 40, 60 or 80 mg/day) in subjects with bipolar I disorder.

Subjects will be initially treated with open-label lurasidone 40 mg/day (Day 1).

Dose adjustment of study drug (20, 40, 60 or 80 mg /day) should occur at the regularly scheduled visits and in increments/decrements of 1 dose level.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has agreed to participate by providing written informed consent.
Subject has completed the 28 week Double-blind Phase of Study D1050296 and all required assessments on the final study visit (Week 28, Visit 28); OR
Subject has experienced a protocol-defined recurrence of any mood event during the Double blind Phase of Study D1050296 and has completed all required assessments on the final study visit; OR
Subject had at least entered the Open-label Phase of Study D1050296 when the Sponsor stopped the study and has completed all required assessments on the final study visit.
Subject is judged by the Investigator to be suitable for participation in a 12 week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.

Exclusion Criteria:

Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.
Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the Columbia Suicide Severity Rating Scale (C-SSRS) at the extension baseline visit (final study visit in Study D1050296).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01575561

Contacts

Contact: Study Manager

1-866-503-6351

Show 43 Study Locations

Sponsors and Collaborators

Sunovion

Investigators

Study Director:

Lurasidone Medical Director, MD

Sunovion

More Information

No publications provided

Responsible Party:	Sunovion
ClinicalTrials.gov Identifier:	NCT01575561 History of Changes
Other Study ID Numbers:	D1050308, 2011-004789-14
Study First Received:	March 28, 2012
Last Updated:	May 28, 2013
Health Authority:	United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Department of Health and Ageing Therapeutic Goods Administration Bulgaria: Bulgarian Drug Agency Chile: Instituto de Salud Publica de Chile Croatia: Ministry of Health and Social Care Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Hungary: National Institute of Pharmacy India: Drugs Controller General of India Poland: The Central Register of Clinical Trials Russia: Ministry of Health of the Russian Federation Serbia and Montenegro: Agency for Drugs and Medicinal Devices Slovakia: State Institute for Drug Control

Keywords provided by Sunovion:

Lurasidone
Latuda
Bipolar Disorder

ClinicalTrials.gov processed this record on June 17, 2013