MedDataX Logo

Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

NCT ID: NCT03249376

Last Updated: 2022-06-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

381 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-27

Study Completion Date

2019-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression

NCT02600494

Bipolar Depression
COMPLETED PHASE3

Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder

NCT04285515

Bipolar Depression Major Depressive Disorder
COMPLETED PHASE3

Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression

NCT02600507

Bipolar Depression
COMPLETED PHASE3

Study of Lumateperone in the Treatment of Patients With Bipolar Mania

NCT06462612

Bipolar Disorder, Manic
RECRUITING PHASE3

Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania

NCT06462586

Bipolar Disorder, Manic
RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bipolar Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lumateperone

Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks

Group Type EXPERIMENTAL

Lumateperone

Intervention Type DRUG

Lumateperone 42 mg (ITI-007 60 mg tosylate)

Placebo

Placebo administered once daily every evening for 6 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lumateperone

Lumateperone 42 mg (ITI-007 60 mg tosylate)

Intervention Type DRUG

Placebo

Placebo

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ITI-007

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of Bipolar I or Bipolar II disorder
* experiencing a current major depressive episode
* able to provide written informed consent

Exclusion Criteria

* any female subject who is pregnant or breast-feeding
* any subject judged to be medically inappropriate for study participation
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Intra-Cellular Therapies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susan Kozauer, MD

Role: STUDY_DIRECTOR

Intra-Cellular Therapies, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinical Site

Birmingham, Alabama, United States

Site Status

Clinical Site

Sherman Oaks, California, United States

Site Status

Clinical Site

Miami, Florida, United States

Site Status

Clinical Site

Orange City, Florida, United States

Site Status

Clinical Site

Atlanta, Georgia, United States

Site Status

Clinical Site

Decatur, Georgia, United States

Site Status

Clinical Site

Chicago, Illinois, United States

Site Status

Clinical Site

Joliet, Illinois, United States

Site Status

Clinical Site

Shreveport, Louisiana, United States

Site Status

Clinical Site

St Louis, Missouri, United States

Site Status

Clinical Site

Buffalo, New York, United States

Site Status

Clinical Site

Charlotte, North Carolina, United States

Site Status

Clinical Site

The Woodlands, Texas, United States

Site Status

Clinical Site

Bothell, Washington, United States

Site Status

Clinical Site

Burgas, , Bulgaria

Site Status

Clinical Site

Kardzhali, , Bulgaria

Site Status

Clinical Site

Lovech, , Bulgaria

Site Status

Clinical Site

Plovdiv, , Bulgaria

Site Status

Clinical Site

Rousse, , Bulgaria

Site Status

Clinical Site

Sofia, , Bulgaria

Site Status

Clinical Site

Targovishte, , Bulgaria

Site Status

Clinical Site

Tsarev Brod, , Bulgaria

Site Status

Clinical Site

Varna, , Bulgaria

Site Status

Clinical Site

Veliko Tarnovo, , Bulgaria

Site Status

Clinical Site

Barranquilla, , Colombia

Site Status

Clinical Site

Bello, , Colombia

Site Status

Clinical Site

Pereira, , Colombia

Site Status

Clinical Site

Moscow, , Russia

Site Status

Clinical Site

Nizhny Novgorod, , Russia

Site Status

Clinical Site

Omsk, , Russia

Site Status

Clinical Site

Saint Petersburg, , Russia

Site Status

Clinical Site

Samara, , Russia

Site Status

Clinical Site

Saratov, , Russia

Site Status

Clinical Site

Tomsk, , Russia

Site Status

Clinical Site

Yekaterinburg, , Russia

Site Status

Clinical Site

Belgrade, , Serbia

Site Status

Clinical Site

Kragujevac, , Serbia

Site Status

Clinical Site

Novi Sad, , Serbia

Site Status

Clinical Site

Ivano-Frankivsk, , Ukraine

Site Status

Clinical Site

Kharkiv, , Ukraine

Site Status

Clinical Site

Kherson, , Ukraine

Site Status

Clinical Site

Lviv, , Ukraine

Site Status

Clinical Site

Odesa, , Ukraine

Site Status

Clinical Site

Poltava, , Ukraine

Site Status

Clinical Site

Smila, , Ukraine

Site Status

Clinical Site

Uzhhorod, , Ukraine

Site Status

Clinical Site

Vinnytsia, , Ukraine

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Bulgaria Colombia Russia Serbia Ukraine

References

Explore related publications, articles, or registry entries linked to this study.

McIntyre RS, Durgam S, Huo J, Kozauer SG, Stahl SM. The Efficacy of Lumateperone in Patients With Bipolar Depression With Mixed Features. J Clin Psychiatry. 2023 Apr 24;84(3):22m14739. doi: 10.4088/JCP.22m14739.

Reference Type DERIVED
PMID: 37103915 (View on PubMed)

Calabrese JR, Durgam S, Satlin A, Vanover KE, Davis RE, Chen R, Kozauer SG, Mates S, Sachs GS. Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial. Am J Psychiatry. 2021 Dec;178(12):1098-1106. doi: 10.1176/appi.ajp.2021.20091339. Epub 2021 Sep 23.

Reference Type DERIVED
PMID: 34551584 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ITI-007-404

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
NCT06372964 RECRUITING PHASE3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
NCT06229210 RECRUITING PHASE3
Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder
NCT04779177 COMPLETED PHASE1
Depression And Bipolar Disorder
NCT00274677 COMPLETED PHASE3
Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
NCT01072630 COMPLETED PHASE3
Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression
NCT00305578 COMPLETED PHASE4
Lamotrigine Phase III Study in Bipolar I Disorder
NCT01602510 COMPLETED PHASE3
A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
NCT01072929 COMPLETED PHASE3
A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
NCT01986101 COMPLETED PHASE3
PET and MRI Brain Imaging of Bipolar Disorder
NCT01880957 COMPLETED NA
Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression
NCT00771134 TERMINATED PHASE2
Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression
NCT00622245 TERMINATED PHASE2
Prevention of Relapse & Recurrence of Bipolar Depression
NCT00961961 COMPLETED PHASE4
Acute Treatment of Bipolar II Depression
NCT00074776 COMPLETED PHASE3
A First In Human Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Single Rising Doses In Healthy Adult Volunteers
NCT00938301 COMPLETED PHASE1
Clinical Trial of Felbamate for Treatment-Resistant Bipolar Depression
NCT00034229 COMPLETED PHASE2
A Study To Investigate The Antidepressant Effect Of Lamotrigine In Patients With Bipolar Disorder Using Lithium
NCT00224510 COMPLETED PHASE3
To Evaluate the Effects of NMRA-335140 on Symptoms of Major Depression in Participants With Bipolar II Disorder.
NCT06429722 COMPLETED PHASE2
Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
NCT01305408 COMPLETED PHASE3
Liothyronine (T3) for Bipolar Depression
NCT00790738 COMPLETED PHASE3
Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects During the Maintenance Phase of Bipolar Illness
NCT00071253 TERMINATED PHASE4
A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
NCT01986114 COMPLETED PHASE3
Maintenance Treatment of Bipolar Depression
NCT00183469 COMPLETED PHASE4
Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder
NCT01677182 TERMINATED PHASE3
Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder
NCT01467700 TERMINATED PHASE3