Blunted Emotion in Major Depressive DisorderPhase 4NCT07824206
Lumateperone Added to Antidepressant Therapy in Adults With Major Depressive Disorder Experiencing Emotional Blunting
A Phase 4 study testing lumateparone 42 mg once daily and lumateparone in people with Blunted Emotion in Major Depressive Disorder, run by Future Options Research, LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether or not adding lumateparone to current antidepressant treatment in adults with major depressive disorder experiencing blunted emotion will reduce or eliminate the blunted emotion as rated by the Oxford Depression Questionnaire. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Blunted Emotion in Major Depressive Disorder
- What is being tested?
- lumateparone 42 mg once daily and lumateparone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Inclusion Criteria: Diagnosis of major depressive disorder documented in the medical record and confirmed through evaluation by the Principal Investigator using the M.I.N.I., Oxford Depression Questionnaire score of \> 50 (substantial emotional blunting), Response of "yes" to the "gold standard" standardized screening question on emotional blunting developed by Price et al(2012): "Emotional effects vary, but may include, for example, feelingemotionally 'numbed' or 'blunted' in some way; lacking positive emotions or negative emotions; feeling detached from the world around you; or 'just not caring' about things you used to care about. Have you experienced such emotional effects during the last 6 weeks?" -
Exclusion Criteria: Concomitant antipsychotics, Concomitant inhibitors of CYP3A4, Concomitant use of cannabis, Moderate to severe hepatic impairment, Primary diagnosis other than major depressive disorder
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Future Options Research
State College, Pennsylvania, 16801
Clinical Coordinator, 8142370001, info@futureoptionsresearch.com
About this study
The purpose of this study is to evaluate whether or not adding lumateparone to current antidepressant treatment in adults with major depressive disorder experiencing blunted emotion will reduce or eliminate the blunted emotion as rated by the Oxford Depression Questionnaire.
Read the detailed description
Adults with Major Depressive Disorder who report blunted emotion that is evidenced by responses on the Oxford Depression Questionnaire will add lumateparone to their current treatment once daily for 8 weeks. Primary endpoint will be change fom baseline to week 8 on the Oxford Depression Questionnaire (ODQ). Secondary endpoints will be change from baseline to week 8 on CGI-I and CGI-S as well as change from baseline to week 8 on quality of life as measured by Q-LES-Q-SF.
- Being tested
- lumateparone 42 mg once daily, lumateparone
- Keywords
- Blunted emotion in Major Depressive Disorder, MDD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumateparone 42 mg once dailyDrug
lumateparone 42 mg once daily added to current antidepressant treatment
lumateparoneDrug
Lumateparone
| Study group | Role | What they receive |
|---|---|---|
| Lumateparone | Other | Investigation of addition of lumateparone for blunted emotion Receives: Drug: lumateparone 42 mg once daily; Drug: lumateparone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 8 in Oxford Depression Questionnaire score
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blunted Emotion in 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A group of 30 adults with confirmed diagnosis of Major Depressive Disorder reporting blunted emotion and confirmed on ODQ will be evaluated. All subjects enrolled will be started on lumateparone in addition to their current antidepressant therapy for 8 weeks
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future Options Research, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Principal investigator, Erin Crown, Future Options Research, LLC
- Investigators
- Erin Crown, PA-C, CAQ-Psychiatry, Principal investigator, Future Options Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824206
- Sponsor's protocol ID
- 007-IIT-0035
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumateperone Added to Antidepressant Therapy in Adults With Major Depressive Disorder Experiencing Emotional Blunting
- ClinicalTrials.gov ID
- NCT07824206
- Acronym / sponsor ID
- 007-IIT-0035
- Keywords
- Blunted emotion in Major Depressive Disorder, MDD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Future Options Research, LLCUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether or not adding lumateparone to current antidepressant treatment in adults with major depressive disorder experiencing blunted emotion will reduce or eliminate the blunted emotion as rated by the Oxford Depression Questionnaire.
Detailed description
Adults with Major Depressive Disorder who report blunted emotion that is evidenced by responses on the Oxford Depression Questionnaire will add lumateparone to their current treatment once daily for 8 weeks. Primary endpoint will be change fom baseline to week 8 on the Oxford Depression Questionnaire (ODQ). Secondary endpoints will be change from baseline to week 8 on CGI-I and CGI-S as well as change from baseline to week 8 on quality of life as measured by Q-LES-Q-SF.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A group of 30 adults with confirmed diagnosis of Major Depressive Disorder reporting blunted emotion and confirmed on ODQ will be evaluated. All subjects enrolled will be started on lumateparone in addition to their current antidepressant therapy for 8 weeks
| Arm | Type | Receives |
|---|---|---|
| Lumateparone | Other | Drug: lumateparone 42 mg once daily, Drug: lumateparoneInvestigation of addition of lumateparone for blunted emotion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| lumateparone 42 mg once dailylumateparone 42 mg once daily added to current antidepressant treatment | Drug | Lumateparone |
| lumateparoneLumateparone | Drug | Lumateparone |
Primary outcome
Change from baseline to week 8 in Oxford Depression Questionnaire score
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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.
Erin Crown, PA-C, CAQ-Psychiatry principal investigator
Future Options Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lumateparone 42 mg once daily and lumateparone in people with Blunted Emotion in Major Depressive Disorder, run by Future Options Research, LLC at 1 site 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?
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: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Coordinator (814-237-0001 ext. 137, info@futureoptionsresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to week 8 in Oxford Depression Questionnaire score (time frame: 8 weeks). 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 17 Sep 2026.