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Completed

NCT Number: NCT01423253

Major Depressive Disorder With Mixed Features - Extension

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Birmingham Psychiatry Pharmaceutical Studies, Inc, Birmingham, Alabama, United States

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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 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.

Treatment and study plan

Lurasidone

Drug

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 names: Latuda

Primary outcomes

  1. Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)

    Time frame: 12 Weeks

    Percentage of subjects with treatment emergent adverse events (TEAEs)

  2. Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)

    Time frame: 12 Weeks

    Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)

  3. Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)

    Time frame: 12 Weeks

    Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)

Secondary outcomes

  1. Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores

    Time frame: Baseline to12 Weeks

    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.

  2. Change From Baseline to Week 12 (LOCF) in CGI-S Score

    Time frame: baseline to week 12

    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.

  3. Change From Baseline to Week 12 (LOCF) in the YMRS Total Score

    Time frame: Baseline to week 12

    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.

  4. Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score

    Time frame: Baseline to week 12

    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.

  5. Change From Baseline to Week 12 (LOCF) in the SDS Total Score

    Time frame: Baseline to week 12

    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).

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma America, Inc.

Industry

Registry information

Official study title

A 12-Week, Open-Label Extension Study For the Treatment of Major Depressive Disorder With Mixed Features

Acronym: RESOLVE3

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 25, 2011
Registry last updated
Apr 8, 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.

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