Blunted Emotion in Major Depressive Disorder
Conditions
Keywords
Blunted emotion in Major Depressive Disorder, MDD
Brief 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.
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.
Interventions
DRUGlumateparone 42 mg once daily
lumateparone 42 mg once daily added to current antidepressant treatment
DRUGlumateparone
Lumateparone
Sponsors
Future Options Research, LLC
Johnson & Johnson
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to week 8 in Oxford Depression Questionnaire score | 8 weeks |
Countries
United States
Contacts
CONTACTClinical Coordinator
PRINCIPAL_INVESTIGATORErin Crown, PA-C, CAQ-Psychiatry
Future Options Research
Outcome results
None listed