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New pill shows promise for schizophrenia psychosis

NCT ID NCT01499563

Symptom relief 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a new drug called ITI-007 can reduce symptoms of schizophrenia during an acute psychotic episode. 335 adults with schizophrenia were randomly assigned to receive ITI-007, a placebo, or an active control for 28 days. The main goal was to measure changes in symptom severity using a standard rating 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
What this could lead to
If successful, this could lead to a new medication to ease schizophrenia symptoms during acute episodes.
What could go wrong
This is an early phase 2 trial, so results may not confirm effectiveness. The drug could also have side effects or fail to outperform placebo.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

335 people

The number who actually took part.

Start date

Dec 2011

Finished

Nov 2013

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 55 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: * Patient's age is 18-55 * Patient has current diagnosis of schizophrenia and is experiencing an acute exacerbation of psychosis * Patient has a history of at least three months exposure to one or more antipsychotic therapy(ies) and a prior response to antipsychotic therapy within the previous five years Exclusion Criteria: * Any female patient who is pregnant or breast-feeding * Any patient presenting with concurrent dementia, delirium, mental retardation, epilepsy, drug-induced psychosis, or history of significant brain trauma * Any patient presenting with schizoaffective disorder, bipolar disorder, acute mania, or major depression with psychotic features * Any patient considered to be an imminent danger to themselves or others * Any patient with hematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or substance abuse as defined by protocol * Any patient judged by the Investigator to be inappropriate for the study

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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

    Garden Grove, California, United States

  • Clinical Site

    Atlanta, Georgia, United States

  • Clinical Site

    Rockville, Maryland, United States

  • Clinical Site

    St Louis, Missouri, United States

  • Clinical Site

    Willingboro, New Jersey, United States

  • Clinical Site

    Philadelphia, Pennsylvania, United States

  • Clinical Site

    Austin, Texas, United States

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