Major Depressive Disorder With Mixed FeaturesPhase 3RESOLVE 1NCT01421134
Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose
A Phase 3 study testing Lurasidone in people with Major Depressive Disorder With Mixed Features, run by Sumitomo Pharma America, Inc. at 43 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder With Mixed Features
- What is being tested?
- Lurasidone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- 43 sitesin 5 countries
- Study dates
- Sep 2011to Oct 2014
- 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 is 18 to 75 years of age, inclusive.
- Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured - Clinical Interview for DSM-IV Disorders - Clinical Trial version [SCID-CT]).
- Subject is currently experiencing a major depressive episode (diagnosed by DSM IV TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Study D1050304):
- Elevated, expansive mood
- Inflated self-esteem or grandiosity
Show all 11Show fewer
- More talkative than usual or pressure to keep talking
- Flight of ideas or subjective experience that thoughts are racing
- Increase in energy or goal-directed activity (either socially, at work or school, or sexually)
- Increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments)
- Decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia)
Who cannot join
- Subject has Axis I or Axis II diagnosis other than MDD that has been the primary focus of treatment within the 3 months prior to screening.
- Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at screening or baseline visit.
- Subject has attempted suicide within the past 3 months.
- Subject has a lifetime history of any bipolar I manic or mixed manic episode.
- Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator.
Trial locations and contacts
43 sites in 5 countries.
43 sites in 5 countries
United States19 sites
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, 35226
Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders
Boston, Massachusetts, 02114
Social Psychiatric Research Inst. (SPRI) Clinical Trials
Brooklyn, New York, 11235
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, 45417
Psychiatry and Behavioral Sciences, Duke
Durham, North Carolina, 27705
Synergy Clinical Research Center
Escondido, California, 92025
Collaborative Neuroscience 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
Clinical Innovations Inc.
Riverside, California, 92506
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
Serbia9 sites
Institute of Mental Health
Belgrade, 11000
Psychiatric Clinic, Clinical Hospital Center"Dr. Dragisa Misovic-Dedinje"
Belgrade, 11000
Health Centre Cacak Department of Psychiatry
Čačak, 32000
Clinical Center Nis, Psychiatric Clinic
Gornja Toponica, 18201
Clinical Center Kragujevac, Psychiatric Clinic
Kragujevac, 34000
Clinic for Mental Health, Clinical Center Nis
Niš, 18000
Special Hospital for Psychiatric Diseases "Sveti Vracevi"
Vojvodina, 23330
Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"
Vršac, 26300
General Hospital "Djordje Joanovic" Psychiatric Dept.
Zrenjanin, 23000
Ukraine7 sites
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
Dnipropetrovsk, 49005
State Institution "Institute of Neurology, Psychiatry and Narcology NAMS of Ukraine", Dep. of Clinical, Social and Child Psychiatry
Kharkiv, 61068
Communal Institution of Kyiv Regional Council "Regional Psychiatric and Narcological Medical Association "Psychiatric Dept. #10 and Psychiatric Dept. #2
Kyiv, 08631
"Lugansk State Medical University"Chair of Psychiatry, Narcology and Medical Psychology; Lugansk Regional Clinical Psychoneurological Hospital, Dispensary Dept. for adults
Luhansk, 91045
Municipal Institution "Lviv Regional State Clinical Psychiatric Hospital, Department #20
Lviv, 79021
Odesa Regional Psychoneurological Dispensary, Outpatient Dept.
Odesa, 65014
Vinnytsya National Medical University n.a. M.I. Pyrogov, Dept. of Psychiatry and Narcology, Vinnytsya Regional Psychoneurological Hospital n.a. O.I. Yushchenko, Dept. no. 14, Dept. no 15
Vinnytsia, 21018
Russia6 sites
Saint Nicholas Psychiatric Hospital.
Saint Petersburg, 190121
City Psychiatry Hospital 4 (Saint Petersburg Psychiatric Admitting Unit)
Saint Petersburg, 191119
Federal State Institution "Saint-Petersburg Research psychoneurogical Institute named after V.M. Bekhtereva"
Saint Petersburg, 193167
Municipal Healthcare Institution"City Clinical Hospital #2, n.a. V.I. Razumovsky" of Healthcare Committee of Administration of Municipal Entity "City of Saratov"
Saratov, 410028
State Healthcare Institution, Saratov Regional Psychiatric Hospital of St.Sophia,
Saratov, 410060
Limited Liability Company "Research-And-Educational Centre of Psychotherapy "Podderzhka"
Stavropol, 355000
United Kingdom2 sites
MAC Clinical Research Limited
Cannock, WS11 0BN
MAC Clinical Research Limited
Manchester, M32 0UT
About this study
Official title: A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone 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.
- Being tested
- Lurasidone, Placebo
- Keywords
- depression, Lurasidone, Latuda
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LurasidoneDrug
Also called Latuda
20, 40, 60 mg, flexible dose, once daily PM 6 weeks
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Lurasidone | Experimental | Lurasidone 20, 40 or 60 mg Receives: Drug: Lurasidone |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores
The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
Measured: Baseline to Week 6
Secondary outcomes (6)
Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score
The 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 6
Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score
The YMRS is an 11-item clinician-rated 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 individual items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.
Measured: Baseline to Week 6
Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score
The 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 6
Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score
The 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 6
Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF).
Measured: Baseline to Week 6
Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF)
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2014
- Study completionOct 2014
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder With Mixed FeaturesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 211 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
- NCT01421134
- Sponsor's protocol ID
- D1050304
- Acronym
- RESOLVE 1
- Status last verified
- Jul 2016
- First submitted
- 17 Aug 2011
- Last updated
- 15 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Clayton AH, Tsai J, Mao Y, Pikalov A, Loebel A. Effect of Lurasidone on Sexual Function in Major Depressive Disorder Patients With Subthreshold Hypomanic Symptoms (Mixed Features): Results From a Placebo-Controlled Trial. J Clin Psychiatry. 2018 Aug 7;79(5):18m12132. doi: 10.4088/JCP.18m12132.
PubMed 30086213Targum SD, Pendergrass JC, Lee S, Loebel A. Ratings surveillance and reliability in a study of major depressive disorder with subthreshold hypomania (mixed features). Int J Methods Psychiatr Res. 2018 Dec;27(4):e1729. doi: 10.1002/mpr.1729. Epub 2018 Jun 26.
PubMed 29943445Targum SD, Suppes T, Pendergrass JC, Lee S, Silva R, Cucchiaro J, Loebel A. Major depressive disorder with subthreshold hypomania (mixed features): Clinical characteristics of patients entered in a multiregional, placebo-controlled study. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Jul 4;68:9-14. doi: 10.1016/j.pnpbp.2016.02.007. Epub 2016 Feb 22.
PubMed 26908089
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone for the Treatment of Major Depressive Disorder With Mixed Features
- ClinicalTrials.gov ID
- NCT01421134
- Acronym / sponsor ID
- RESOLVE 1 / D1050304
- Keywords
- depression, Lurasidone, Latuda
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Posted 9 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lurasidone | Experimental | Drug: LurasidoneLurasidone 20, 40 or 60 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
- Subject is 18 to 75 years of age, inclusive.
- Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured - Clinical Interview for DSM-IV Disorders - Clinical Trial version [SCID-CT]).
- Subject is currently experiencing a major depressive episode (diagnosed by DSM IV TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Study D1050304):
Key exclusion criteria (5 listed)
- Subject has Axis I or Axis II diagnosis other than MDD that has been the primary focus of treatment within the 3 months prior to screening.
- Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at screening or baseline visit.
- Subject has attempted suicide within the past 3 months.
- Subject has a lifetime history of any bipolar I manic or mixed manic episode.
- Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator.
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: Latuda20, 40, 60 mg, flexible dose, once daily PM 6 weeks | Drug | Lurasidone |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores
Time frame: Baseline to Week 6
The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
6 secondary outcomes
Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score
Time frame: Baseline to Week 6
Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score
Time frame: Baseline to Week 6
Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score
Time frame: Baseline to Week 6
Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score
Time frame: Baseline to Week 6
Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF).
Time frame: Baseline to Week 6
Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF)
Time frame: Baseline to Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30086213Clayton AH, Tsai J, Mao Y, Pikalov A, Loebel A. Effect of Lurasidone on Sexual Function in Major Depressive Disorder Patients With Subthreshold Hypomanic Symptoms (Mixed Features): Results From a Placebo-Controlled Trial. J Clin Psychiatry. 2018 Aug 7;79(5):18m12132. doi: 10.4088/JCP.18m12132.
- Derived from this study: PubMed 29943445Targum SD, Pendergrass JC, Lee S, Loebel A. Ratings surveillance and reliability in a study of major depressive disorder with subthreshold hypomania (mixed features). Int J Methods Psychiatr Res. 2018 Dec;27(4):e1729. doi: 10.1002/mpr.1729. Epub 2018 Jun 26.
- Derived from this study: PubMed 26908089Targum SD, Suppes T, Pendergrass JC, Lee S, Silva R, Cucchiaro J, Loebel A. Major depressive disorder with subthreshold hypomania (mixed features): Clinical characteristics of patients entered in a multiregional, placebo-controlled study. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Jul 4;68:9-14. doi: 10.1016/j.pnpbp.2016.02.007. Epub 2016 Feb 22.
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.
43 sites in 5 countries: 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 With Mixed Features, run by Sumitomo Pharma America, Inc. at 43 sites in 5 countries.
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 11 inclusion and 5 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 15 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Serbia, Ukraine, Russia, United Kingdom. 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. Some participants in this study may receive a placebo. 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 9 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?
Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01421134, which also lists 3 linked publications.
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 15 Jul 2016.