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New antipsychotic ITI-007 put to the test in large schizophrenia trial

NCT ID NCT02469155

Disease control Sponsor: Intra-Cellular Therapies, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental drug called ITI-007 in 696 adults with schizophrenia who were having a sudden worsening of symptoms. Participants received either ITI-007, a placebo, or an active comparator (risperidone) for 6 weeks. The main goal was to see if ITI-007 reduces schizophrenia symptoms better than placebo, as measured by a standard symptom scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ITI-007 (an experimental antipsychotic drug)
What this could lead to
If successful, ITI-007 could offer a new treatment option for schizophrenia with possibly fewer side effects than current drugs.
What could go wrong
This is a completed Phase 3 trial, but results may not show clear benefit over placebo or existing drugs. Side effects and individual responses vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

696 people

The number who actually took part.

Start date

Jun 2015

Finished

Aug 2016

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia * experiencing an acute exacerbation of psychosis Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

Contacts and locations

Locations

  • Clinical Site

    Little Rock, Arkansas, United States

  • Clinical Site

    Springdale, Arkansas, United States

  • Clinical Site

    Culver City, California, United States

  • Clinical Site

    Lemon Grove, California, United States

  • Clinical Site

    Long Beach, California, United States

  • Clinical Site

    San Diego, California, United States

  • Clinical Site

    North Miami, Florida, United States

  • Clinical Site

    Berlin, New Jersey, United States

  • Clinical Site

    Marlton, New Jersey, United States

  • Clinical Site

    Austin, Texas, United States

  • Clinical Site

    Dallas, Texas, United States

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