Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05850689 · ClinicalTrials.gov registry record · Phase 3
Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
A Phase 3 study of Major Depressive Disorder, sponsored by Intra-Cellular Therapies.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 470
- Enrollment target
- 20
- Study locations
NCT05850689: Recruiting Phase 3 study of Major Depressive Disorder, sponsored by Intra-Cellular Therapies.
NCT05850689 is a Phase 3 study of Major Depressive Disorder that is actively recruiting participants, run by Intra-Cellular Therapies. The registered enrollment target is 470 participants, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (25% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05850689, a Phase 3 study of Major Depressive Disorder, is actively recruiting participants, sponsored by Intra-Cellular Therapies.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 470 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
Primary Outcome
The MADRS is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lumateperone
Study Locations (20)
Florida
- Clinical Site - Clermont
- Clinical Site - Hialeah
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Tampa
Kansas
- Clinical Site - Kansas City
- Clinical Site - Kansas City
- Clinical Site - Overland Park
Ohio
- Clinical Site - Avon Lake
- Clinical Site - Cincinnati
- Clinical Site - Columbus
Georgia
- Clinical Site - Atlanta
- Clinical Site - Decatur
Alabama
- Clinical Site - Huntsville
California
- Clinical Site - Pico Rivera
Connecticut
- Clinical Site - Farmington
Massachusetts
- Clinical Site - Methuen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 470 participants |
| Start Date | 2023-05-02 |
| Est. Completion | 2026-10 |
| Phase | Phase 3 |
What NCT05850689 shows while recruiting
NCT05850689 is an interventional study that assigns participants to a tested intervention. The registered 470 participants enrollment target is mid-sized for trials with a published cap, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (25% higher).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05850689 names 20 study sites across 10 states, led by Florida, Kansas, Ohio.
Frequently Asked Questions
What is clinical trial NCT05850689 about?
NCT05850689 is a clinical study titled "Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder". This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
What is the current status of trial NCT05850689?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 470 participants. The study started on 2023-05-02. Estimated completion is 2026-10.
What conditions does trial NCT05850689 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT05850689?
The interventions under investigation include: Placebo (DRUG), Lumateperone (DRUG).
Who is sponsoring clinical trial NCT05850689?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05850689 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05850689's enrollment target sits among peer trials
470 37th of 282 higher than 246 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
RECRUITING · Phase 3
-
Study to Assess the Safety and Effectiveness of NMRA-335140-501
RECRUITING · Phase 3
-
Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
RECRUITING · Phase 3
-
The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder
RECRUITING · Phase 3
-
"A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"
RECRUITING · Phase 3
-
NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05256940 · 470 participants · NA
Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide
- NCT05458219 · 470 participants · Phase 1
A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
- NCT05935384 · 470 participants
SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation
- NCT05983432 · 470 participants · Phase 1
Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI