Major Depressive Disorder With Mixed Features - Extension (RESOLVE3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01423253
First received: August 23, 2011
Last updated: March 10, 2016
Last verified: March 2016

August 23, 2011
March 10, 2016
September 2011
October 2013   (final data collection date for primary outcome measure)
  • Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    Percentage of subjects with treatment emergent adverse events (TEAEs)
  • Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)
  • Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)
SAEs, AEs, Discontinuations due to SAEs and AEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
Proportion of subjects with adverse events (AEs) and serious adverse events (SAEs) Discontinuations due to AEs and SAEs Change in movement disorders, as assessed by the Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson-Angus Rating Scale (SARS) Change in sexual functioning, as assessed by the Changes in Sexual Functioning Questionnaire (CSFQ).
Complete list of historical versions of study NCT01423253 on ClinicalTrials.gov Archive Site
  • Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores [ Time Frame: Baseline to12 Weeks ] [ Designated as safety issue: No ]
    Mean change from baseline to week 12 (LOCF) in Montgomery-Asberg Depression Rating Scale (MADRS) total scores The MADRS is a clinician-rated assessment of the subject's level of depression and consists of 10 items. Each item is rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the ten items and ranges from 0 to 60. Higher scores are associated with greater severity.
  • Change From Baseline to Week 12 (LOCF) in CGI-S Score [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
    The Clinical Global Impression - Severity of illness (CGI-S) score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.
  • Change From Baseline to Week 12 (LOCF) in the YMRS Total Score [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
    The Young Mania Rating Scale (YMRS) is an 11-item instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.
  • Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
    The Hamilton Rating Scale for Anxiety (HAM-A) is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.
  • Change From Baseline to Week 12 (LOCF) in the SDS Total Score [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
    The Sheehan Disability Scale (SDS) is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).
MADRS [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
Mean change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total scores Proportion of subjects who achieve a response, defined as ≥ 50% reduction from double-blind baseline on the MADRS total score Proportion of subjects who achieve remission, defined as a MADRS total score of ≤ 12
Not Provided
Not Provided
 
Major Depressive Disorder With Mixed Features - Extension
A 12-Week, Open-Label Extension Study For the Treatment of Major Depressive Disorder With Mixed Features
Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features over time.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
Drug: Lurasidone
Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed
Other Name: Latuda
Experimental: Lurasidone 20, 40, 60 mg
Lurasidone 20, 40, or 60 mg/day flexibly dosed
Intervention: Drug: Lurasidone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.

Subject has completed 6 weeks of treatment in Study D1050304 (NCT#01421134) or Study D1050305 (NCT#01423240).

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 answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at baseline (Day 43 in Study D1050304 or D1050305).

Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01423253
D1050306
Yes
Not Provided
Not Provided
Sunovion
Sunovion
Not Provided
Study Director: Medical Director, MD Sunovion
Sunovion
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP