ITI-007 (Lumateperone Tosylate) for Schizophrenia

NCT03817528 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 7716
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to offer open label ITI-007 treatment to patients who poorly respond or poorly tolerate approved medications.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Schizophrenia Symptoms

  schizophrenia symptoms will be measures using the Positive and Negative Symptom Scale (PANSS) Total PANSS score (range: 30-210). Individual items scored from 1(absent) to 7 (extremely severe). Total PANSS score is sum of the 30 individual items with lowest score (30) indicating all symptoms absent and the maximum score (210) indicating all symptoms rated as extremely severe.

  Change from baseline in Total PANSS score after 6 month treatment

Study Arms (1)

ITI-007

EXPERIMENTAL

Open-Label ITI-007 40-60 mg

Drug: ITI-007

Interventions

ITI-007 DRUG

ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events

Also known as: Lumateperone tosylate

ITI-007

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder
• Has capacity to provide informed consent
• Medically stable for study participation
• Judged clinically not to be at significant suicide or violence risk
• Inadequate response or tolerability to previously antipsychotic therapy, as defined by at least one of the following: prior clozapine failure, a PANSS\>80 despite at least six weeks of a current antipsychotic therapy, a Clinical Global Impressions scale-Improvement (CGI-I) of 4 after at least two six week trials of antipsychotics (retrospective assessment) or failure to tolerate an adequate dose of at least antipsychotics (as defined by the Physicians Desk Reference)

You may not qualify if:

• Substance abuse within last 90 days
• ECG abnormality that is clinically significant
• Pregnancy, lactation, or lack of use of effective birth control
• Presence or positive history of significant unstable medical or neurological illness (including any history of seizure disorder, hepatitis, renal insufficiency or mental retardation), history of HIV
• Clinically significant abnormal laboratory tests, positive for hepatitis B or C or liver function tests (LFTs) \> 2x Upper Limit of Normal, use of strong CYP3A4 inhibitors or inducers
• History or presence of concomitant major psychiatric illness.
• Use of other antipsychotic medications at baseline.
• Use of another investigational medication in the previous 4 weeks

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Intra-Cellular Therapies, Inc.: collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Marlene Carlson, MPH
• Organization: New York State Psychiatric Institute

marlene.carlson@nyspi.columbia.edu

646-774-5340

Study Officials

• Jeffrey A Lieberman, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: None (open label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, New York State Psychiatric Institute

Model Details: open-label

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: January 25, 2019
• Study Start: March 1, 2019
• Primary Completion: September 23, 2020
• Study Completion: September 23, 2020
• Last Updated: November 4, 2021
• Results First Posted: November 2, 2021

Record last verified: 2021-11

Locations

US (1)