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New pill aims to lift the fog of bipolar depression

NCT ID NCT02600494

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested a new medication, lumateperone, to see if it can safely ease depression in people with bipolar I or II disorder. Over 550 adults took either the drug or a placebo for six weeks. Researchers measured changes in depression symptoms using a standard rating scale.

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

554 people

The number who actually took part.

Started

Dec 2015

Finished

Jul 2019

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 75 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.

Major 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 Major 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.

bipolar depression bipolar disorder bipolar I disorder bipolar II disorder

As listed by the trial registrant

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

Bipolar depression

Contacts and locations

Locations

  • Clinical Site

    Little Rock, Arkansas, United States

  • Clinical Site

    Rogers, Arkansas, United States

  • Clinical Site

    Cerritos, California, United States

  • Clinical Site

    Culver City, California, United States

  • Clinical Site

    Garden Grove, California, United States

  • Clinical Site

    Lemon Grove, California, United States

  • Clinical Site

    National City, California, United States

  • Clinical Site

    Oakland, California, United States

  • Clinical Site

    Oceanside, California, United States

  • Clinical Site

    Orange, California, United States

  • Clinical Site

    Pico Rivera, California, United States

  • Clinical Site

    Riverside, California, United States

  • Clinical Site

    San Diego, California, United States

  • Clinical Site

    San Marcos, California, United States

  • Clinical Site

    Santa Rosa, California, United States

  • Clinical Site

    Colorado Springs, Colorado, United States

  • Clinical Site

    Bradenton, Florida, United States

  • Clinical Site

    Fort Myers, Florida, United States

  • Clinical Site

    Jacksonville, Florida, United States

  • Clinical Site

    Lauderhill, Florida, United States

  • Clinical Site

    Miami, Florida, United States

  • Clinical Site

    North Miami, Florida, United States

  • Clinical Site

    Orlando, Florida, United States

  • Clinical Site

    Atlanta, Georgia, United States

  • Clinical Site

    Chicago, Illinois, United States

  • Clinical Site

    Hoffman Estates, Illinois, United States

  • Clinical Site

    Lake Charles, Louisiana, United States

  • Clinical Site

    Baltimore, Maryland, United States

  • Clinical Site

    Boston, Massachusetts, United States

  • Clinical Site

    O'Fallon, Missouri, United States

  • Clinical Site

    St Louis, Missouri, United States

  • Clinical Site

    Las Vegas, Nevada, United States

  • Clinical Site

    Berlin, New Jersey, United States

  • Clinical Site

    Cherry Hill, New Jersey, United States

  • Clinical Site

    Marlton, New Jersey, United States

  • Clinical Site

    Toms River, New Jersey, United States

  • Clinical Site

    Brooklyn, New York, United States

  • Clinical Site

    Cedarhurst, New York, United States

  • Clinical Site

    New York, New York, United States

  • Clinical Site

    Rochester, New York, United States

  • Clinical Site

    Staten Island, New York, United States

  • Clinical Site

    Cincinnati, Ohio, United States

  • Clinical Site

    Cleveland, Ohio, United States

  • Clinical Site

    Dayton, Ohio, United States

  • Clinical Site

    Garfield Heights, Ohio, United States

  • Clinical Site

    Oklahoma City, Oklahoma, United States

  • Clinical Site

    Allentown, Pennsylvania, United States

  • Clinical Site

    Norristown, Pennsylvania, United States

  • Clinical Site

    Philadelphia, Pennsylvania, United States

  • Clinical Site

    Memphis, Tennessee, United States

  • Clinical Site

    Austin, Texas, United States

  • Clinical Site

    Dallas, Texas, United States

  • Clinical Site

    Houston, Texas, United States

  • Clinical Site

    Petersburg, Virginia, United States

  • Clinical Site

    Everett, Washington, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.