NCT02282761

Brief Summary

The study will be conducted as a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P50-P75 for phase_3 schizophrenia

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_3 schizophrenia

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
10.1 years until next milestone

Results Posted

Study results publicly available

October 2, 2025

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

October 31, 2014

Results QC Date

March 26, 2025

Last Update Submit

September 16, 2025

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score

    The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Thus, the PANSS Total score minimum is 30 and the maximum is 210, with higher numbers indicating more severe symptoms.

    28 days

Secondary Outcomes (1)

  • Change From Baseline to Day 28 in Clinical Global Impressions-Severity of Illness Scale

    28 days

Study Arms (3)

Lumateperone 28 mg (ITI-007 40 mg Tosylate)

EXPERIMENTAL

Lumateperone 28 mg (ITI-007 40 mg Tosylate) administered orally as formulated capsules once daily for 28 days

Drug: ITI-007

Lumateperone 42 mg (ITI-007 60 mg Tosylate)

EXPERIMENTAL

Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 28 days

Drug: ITI-007

Placebo

PLACEBO COMPARATOR

Placebo administered orally as formulated capsules once daily for 28 days

Drug: Placebo

Interventions

ITI-007DRUG
Lumateperone 28 mg (ITI-007 40 mg Tosylate)Lumateperone 42 mg (ITI-007 60 mg Tosylate)
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia
  • experiencing an acute exacerbation of psychosis

You may not qualify if:

  • any subject unable to provide informed consent
  • any female subject who is pregnant or breast-feeding
  • any subject judged to be medically inappropriate for study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Clinical Site

Little Rock, Arkansas, United States

Location

Clinical Site

Springdale, Arkansas, United States

Location

Clinical Site

Escondido, California, United States

Location

Clinical Site

Garden Grove, California, United States

Location

Clinical Site

Long Beach, California, United States

Location

Clinical Site

San Diego, California, United States

Location

Clinical Site

Fort Lauderdale, Florida, United States

Location

Clinical Site

Rockville, Maryland, United States

Location

Clinical Site

St Louis, Missouri, United States

Location

Clinical Site

Marlton, New Jersey, United States

Location

Clinical Site

Austin, Texas, United States

Location

Related Publications (2)

  • Citrome L, Durgam S, Edwards JB, Davis RE. Lumateperone for the Treatment of Schizophrenia: Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2023 Mar 6;84(2):22r14631. doi: 10.4088/JCP.22r14631.

    PMID: 36883881DERIVED

  • Correll CU, Davis RE, Weingart M, Saillard J, O'Gorman C, Kane JM, Lieberman JA, Tamminga CA, Mates S, Vanover KE. Efficacy and Safety of Lumateperone for Treatment of Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Apr 1;77(4):349-358. doi: 10.1001/jamapsychiatry.2019.4379.

    PMID: 31913424DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
ITI Clinical Trials
Organization
Intra-Cellular Therapies, Inc.
ITCIClinicalTrials@itci-inc.com
646-440-9333

Study Officials

  • Kimberly Vanover, Ph.D.

    Intra-Cellular Therapies, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2014

First Posted

November 4, 2014

Study Start

November 1, 2014

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

October 2, 2025

Results First Posted

October 2, 2025

Record last verified: 2025-09

Locations

US(11)