Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02600494 · ClinicalTrials.gov registry record · Phase 3
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
A Phase 3 study of Bipolar Depression, sponsored by Intra-Cellular Therapies.
- Completed
- Registry status
- Phase 3
- Development phase
- 554
- Enrollment target
- 20
- Study locations
NCT02600494: Completed Phase 3 study of Bipolar Depression, sponsored by Intra-Cellular Therapies.
NCT02600494 is a Phase 3 study of Bipolar Depression that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 554 participants, above the 197-participant average among 29 other Bipolar Depression trials with a reported enrollment target (181% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02600494, a Phase 3 study of Bipolar Depression, has completed, sponsored by Intra-Cellular Therapies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 554 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B. Part A is a randomized, double-blind, placebo-controlled study. In Part B, patients who safely complete participation in part A may be enrolled in an open-label extension.
Primary Outcome
The Montgomery-Åsberg Depression Rating Scale (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 ITI-007 (Lumateperone)
Study Locations (20)
California
- Clinical Site - Cerritos
- Clinical Site - Culver City
- Clinical Site - Garden Grove
- Clinical Site - Lemon Grove
- Clinical Site - National City
- Clinical Site - Oakland
- Clinical Site - Oceanside
- Clinical Site - Orange
- Clinical Site - Pico Rivera
- Clinical Site - Riverside
- Clinical Site - San Diego
- Clinical Site - San Marcos
- Clinical Site - Santa Rosa
Florida
- Clinical Site - Bradenton
- Clinical Site - Fort Myers
- Clinical Site - Jacksonville
- Clinical Site - Lauderhill
Arkansas
- Clinical Site - Little Rock
- Clinical Site - Rogers
Colorado
- Clinical Site - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 554 participants |
| Start Date | 2015-12-15 |
| Est. Completion | 2019-07-24 |
| Phase | Phase 3 |
What the finished NCT02600494 record still lists
NCT02600494 is an interventional study that assigns participants to a tested intervention. The registered 554 participants enrollment target is mid-sized for trials with a published cap, above the 197-participant average among 29 other Bipolar Depression trials with a reported enrollment target (181% higher).
The record links to 1 condition, with Bipolar Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02600494 names 20 study sites across 4 states, led by California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT02600494 about?
NCT02600494 is a clinical study titled "Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression". The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B. Part A is a randomized, double-blind, placebo-controlled study. In Par...
What is the current status of trial NCT02600494?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 554 participants. The study started on 2015-12-15. Estimated completion is 2019-07-24.
What conditions does trial NCT02600494 study?
This clinical trial studies the following conditions: Bipolar Depression.
What interventions are being tested in trial NCT02600494?
The interventions under investigation include: Placebo (DRUG), ITI-007 (Lumateperone) (DRUG).
Who is sponsoring clinical trial NCT02600494?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02600494 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Depression
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 NCT02600494's enrollment target sits among peer trials
554 4th of 29 higher than 26 of 29 other Bipolar Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Depression 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
-
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
RECRUITING · Phase 3
-
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
RECRUITING · Phase 3
-
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
COMPLETED · Phase 3
-
Pediatric Open-Label Extension Study
COMPLETED · Phase 3
-
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
COMPLETED · Phase 3
-
Seroquel in Bipolar Depression Versus SSRI
COMPLETED · 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
- NCT05786924 · 554 participants · Phase 1
Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies
- NCT06799000 · 555 participants · Phase 3
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)
- NCT06840392 · 555 participants · Phase 3
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
- NCT06074588 · 556 participants · Phase 3
Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)
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