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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02600494
The ClinicalTrials.gov registry entry for NCT02600494 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 554 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 197-participant average among 29 other Bipolar Depression trials with a reported enrollment target (181% higher). The listed sponsor is Intra-Cellular Therapies, which has 37 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.