NCT07824206

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
17mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Sep 2026Mar 2028

Study Start

First participant enrolled

September 1, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

1.3 years

First QC Date

September 11, 2026

Last Update Submit

September 11, 2026

Conditions

Blunted Emotion in Major Depressive Disorder

Keywords

Blunted emotion in Major Depressive DisorderMDD

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to week 8 in Oxford Depression Questionnaire score

    8 weeks

Study Arms (1)

Lumateparone

OTHER

Investigation of addition of lumateparone for blunted emotion

Drug: lumateparone 42 mg once dailyDrug: lumateparone

Interventions

lumateparone 42 mg once dailyDRUG

lumateparone 42 mg once daily added to current antidepressant treatment

Lumateparone
lumateparoneDRUG

Lumateparone

Lumateparone

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Future Options Research

State College, Pennsylvania, 16801, United States

Location

Study Officials

  • Erin Crown, PA-C, CAQ-Psychiatry

    Future Options Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Coordinator

CONTACT

814-237-0001info@futureoptionsresearch.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Owner/Principal Investigator

Study Record Dates

First Submitted

September 11, 2026

First Posted

September 17, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

September 17, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)