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NCT04985942 · ClinicalTrials.gov registry record · Phase 3
Clinical Trial 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.
- Completed
- Registry status
- Phase 3
- Development phase
- 485
- Enrollment target
- 20
- Study locations
NCT04985942: Completed Phase 3 study of Major Depressive Disorder, sponsored by Intra-Cellular Therapies.
NCT04985942 is a Phase 3 study of Major Depressive Disorder that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 485 participants, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (29% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04985942, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by Intra-Cellular Therapies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 485 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
Change from baseline to Day 43 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. 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)
California
- Clinical Site - Glendale
- Clinical Site - Oceanside
- Clinical Site - Redlands
- Clinical Site - Temecula
- Clinical Site - Upland
Other
- Clinical Site - Burgas
- Clinical Site - Kazanlak
- Clinical Site - Pleven
- Clinical Site - Rousse
- Clinical Site - Tsarev Brod
Florida
- Clinical Site - Fort Lauderdale
- Clinical Site - Jacksonville
- Clinical Site - Orlando
New Jersey
- Clinical Site - Berlin
- Clinical Site - Toms River
Arizona
- Clinical Site - Phoenix
Georgia
- Clinical Site - Decatur
Massachusetts
- Clinical Site - Boston
New York
- Clinical Site - Cedarhurst
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 485 participants |
| Start Date | 2021-07-30 |
| Est. Completion | 2024-02-27 |
| Phase | Phase 3 |
What the finished NCT04985942 record still lists
NCT04985942 is an interventional study that assigns participants to a tested intervention. The registered 485 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 (29% 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.
NCT04985942 names 20 study sites across 9 states, led by California, Other, Florida.
Frequently Asked Questions
What is clinical trial NCT04985942 about?
NCT04985942 is a clinical study titled "Clinical Trial 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 NCT04985942?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 485 participants. The study started on 2021-07-30. Estimated completion is 2024-02-27.
What conditions does trial NCT04985942 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT04985942?
The interventions under investigation include: Placebo (DRUG), Lumateperone (DRUG).
Who is sponsoring clinical trial NCT04985942?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04985942 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Massachusetts. 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 NCT04985942's enrollment target sits among peer trials
485 34th of 282 higher than 249 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.
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