Major Depressive DisorderPhase 3RESOLVE3NCT01423253
Major Depressive Disorder With Mixed Features - Extension
A Phase 3 study testing Lurasidone in people with Major Depressive Disorder, run by Sumitomo Pharma America, Inc. at 17 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Lurasidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 17 sitesUnited States
- Study dates
- Sep 2011to Oct 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Birmingham Psychiatry Pharmaceutical Studies, Inc
Birmingham, Alabama, 35226
Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders
Boston, Massachusetts, 02114
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231
Dept. of Psychiatry, UT Southwestern Medical Center
Dallas, Texas, 75390-8849
Midwest Clinical Research Center
Dayton, Ohio, 45408
Psychiatry and Behavioral Sciences, Duke
Durham, North Carolina, 27705
Synergy Clinical Research Center
Escondido, California, 92025
Collaborative Neuro Science Network, Inc.
Garden Grove, California, 92845
Village Clinical Research Inc.
New York, New York, 10003
Stanford -VA Palo Alto Health Care System
Palo Alto, California, 94304
CRI Worldwide - Kirkbride
Philadelphia, Pennsylvania, 19139
Finger Lakes Clinical Research
Rochester, New York, 14618
St. Charles Psychiatric Associates/Midwest Research Group
Saint Charles, Missouri, 63301
Artemis Institute for Clinical Research
San Diego, California, 92123
Florida Clinical Research Center, LLC
Sarasota, Florida, 34201
Behavioral Medical Research of Staten Island
Staten Island, New York, 10305
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309
About this study
Official title: 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Lurasidone
- Keywords
- Depression, Lurasidone, Latuda
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LurasidoneDrug
Also called Latuda
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
| Study group | Role | What they receive |
|---|---|---|
| Lurasidone 20, 40, 60 mg | Experimental | Lurasidone 20, 40, or 60 mg/day flexibly dosed Receives: Drug: Lurasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)
Percentage of subjects with treatment emergent adverse events (TEAEs)
Measured: 12 Weeks
Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)
Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)
Measured: 12 Weeks
Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)
Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)
Measured: 12 Weeks
Secondary outcomes (5)
Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores
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.
Measured: Baseline to12 Weeks
Change From Baseline to Week 12 (LOCF) in CGI-S Score
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.
Measured: baseline to week 12
Change From Baseline to Week 12 (LOCF) in the YMRS Total Score
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.
Measured: Baseline to week 12
Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score
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.
Measured: Baseline to week 12
Change From Baseline to Week 12 (LOCF) in the SDS Total Score
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).
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423253
- Sponsor's protocol ID
- D1050306
- Acronym
- RESOLVE3
- Status last verified
- Mar 2016
- First submitted
- 23 Aug 2011
- Last updated
- 8 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Open-Label Extension Study For the Treatment of Major Depressive Disorder With Mixed Features
- ClinicalTrials.gov ID
- NCT01423253
- Acronym / sponsor ID
- RESOLVE3 / D1050306
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Lurasidone, Latuda
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 25 Aug 2011 (estimated)
- Results
- Posted 14 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lurasidone 20, 40, 60 mg | Experimental | Drug: LurasidoneLurasidone 20, 40, or 60 mg/day flexibly dosed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LurasidoneAlso: LatudaLurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed | Drug | Lurasidone 20, 40, 60 mg |
Primary outcome
Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)
Time frame: 12 Weeks
Percentage of subjects with treatment emergent adverse events (TEAEs)
Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: 12 Weeks
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
Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)
5 secondary outcomes
Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores
Time frame: Baseline to12 Weeks
Change From Baseline to Week 12 (LOCF) in CGI-S Score
Time frame: baseline to week 12
Change From Baseline to Week 12 (LOCF) in the YMRS Total Score
Time frame: Baseline to week 12
Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score
Time frame: Baseline to week 12
Change From Baseline to Week 12 (LOCF) in the SDS Total Score
Time frame: Baseline to week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director, MD study director
Sumitomo Pharma America, Inc.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lurasidone in people with Major Depressive Disorder, run by Sumitomo Pharma America, Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) (time frame: 12 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2016.