Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07747389 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study of Lumateperone Versus Placebo in Participants With Major Depressive Disorder

Study acronym: CANDLE
StatusNot Yet Recruiting
PhasePhase 3
Started2026-10-20
View on ClinicalTrials.gov ↗

Amendment history

2026-08-27
Study Status v1
Re-verified, no change to tracked fields
2026-07-30
Original filing
The purpose of the study is to assess how well each dose of lumateperone (Dose 1 and 2) works when given alone as compared to placebo in participants with major depressive disorder (MDD; a medical condition characterized by a persistent feeling of deep sadness, hopelessness, and a loss of interest in activities for a prolonged period of time and interfere with ability to function).
Trial Details
NCT Number NCT07747389
Lead Sponsor Intra-Cellular Therapies, Inc.
Conditions Depressive Disorder, Major
Enrollment 585 participants
Start Date 2026-10-20
Primary Completion 2029-09-20 (estimated)
Study Completion 2029-09-20 (estimated)
Updated on ClinicalTrials.gov 2026-08-31