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New schizophrenia drug goes Head-to-Head with standard antipsychotics in Long-Term trial

NCT ID NCT01129674

Disease control Sponsor: Denovo Biopharma LLC 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing an experimental drug called LY2140023 in people with schizophrenia who have already completed a short-term trial of the same drug. The study compares LY2140023 to standard antipsychotic medications like olanzapine, aripiprazole, risperidone, and quetiapine over 104 weeks. The main goal is to see how well patients tolerate LY2140023 and whether it helps manage their symptoms. About 560 participants will take their assigned treatment twice daily, and researchers will track side effects and symptom changes.

What this could mean

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

Active substance
an experimental schizophrenia drug called LY2140023
What this could lead to
If LY2140023 works, it could offer a new option for people with schizophrenia who need long-term treatment. It might also provide a different way to manage symptoms with fewer side effects than current antipsychotics.
What could go wrong
LY2140023 may not control symptoms as well as standard antipsychotics, or it may cause side effects that make people stop treatment. This is a mid-to-late stage trial, but results are not yet available, and the drug could fail to show a benefit.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

560 people

The number who actually took part.

Start date

Jun 2010

Finished

Oct 2012

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 65 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: * Must have met all entry criteria for, and have completed, an acute, placebo-controlled clinical trial of LY2140023 (such as Study H8Y-MC-HBBM, or other acute, placebo-controlled LY2140023 studies if allowed by the protocols for those studies). * Female participants of childbearing potential must agree to use a single, effective, medically acceptable method of birth control. * Participants must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required by the protocol. * Participants must be able to understand the nature of the study and have given their own informed consent. Exclusion Criteria: * Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an investigational product or nonapproved use of a drug or device (other than LY2140023), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. * Participants for whom treatment with olanzapine, risperidone, aripiprazole, quetiapine, or LY2140023, as specified in this protocol, is relatively or absolutely clinically contraindicated. * Participants who have received treatment with clozapine at doses greater than 200 mg daily within 12 months prior to study enrollment, or who have received any clozapine at all during the month before study enrollment. * Participants who require concomitant treatment with any other medication with primary central nervous system activity, other than those allowed in study protocol. * Participants have risk of suicide. * Participants diagnosed with substance dependence or substance abuse within the 6 months prior to study enrollment. * Participants diagnosed with substance-induced psychosis within 7 days of study enrollment or at any time during the study. * Female participants who are pregnant, nursing, lactating or who intend to become pregnant within 30 days of completing the study. * Have known glaucoma. * Have a history of some types of seizures. * Have seizure liability inconsistent with the exclusion criteria of the completed acute feeder study. * Participants who have had electroconvulsive therapy (ECT) within 3 months of study enrollment or who will have ECT at any time during the study. * Participants with known Human Immunodeficiency Virus positive (HIV+) status. * Participants have a serious disease, such as recent stroke, heart, liver, kidney, lung or blood diseases * Participants with Parkinson's disease * Are incapable of participating in the study or are unwilling to engage in a meaningful way as study participants.

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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

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Little Rock, Arkansas, 72201, United States

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    Escondido, California, 92025, United States

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    Garden Grove, California, 92845, United States

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    Long Beach, California, 90813, United States

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    National City, California, 91950, United States

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    Oakland, California, 94612, United States

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    Oceanside, California, 92056, United States

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    Paramount, California, 90723, United States

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    Pasadena, California, 91106, United States

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    San Diego, California, 92123, United States

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    Sherman Oaks, California, 91403, United States

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    Torrance, California, 90502, United States

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    Washington D.C., District of Columbia, 20016, United States

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    Fort Lauderdale, Florida, 33308, United States

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    Hollywood, Florida, 33021, United States

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    Kissimmee, Florida, 34741, United States

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    Maitland, Florida, 32751, United States

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    University Park, Florida, 34201, United States

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    Atlanta, Georgia, 30308, United States

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    Chicago, Illinois, 60640, United States

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    Hoffman Estates, Illinois, 60169, United States

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    Indianapolis, Indiana, 46222, United States

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    Wichita, Kansas, 67207, United States

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    Lake Charles, Louisiana, 70629, United States

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    Shreveport, Louisiana, 71104, United States

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    Flowood, Mississippi, 39232, United States

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    Creve Coeur, Missouri, 63141, United States

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    Marlton, New Jersey, 08053, United States

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    Buffalo, New York, 14215, United States

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    Cedarhurst, New York, 11516, United States

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    Holliswood, New York, 11423, United States

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    New York, New York, 10032, United States

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    Rochester, New York, 14615, United States

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    Cincinnati, Ohio, 45219, United States

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    Dayton, Ohio, 45417, United States

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    Philadelphia, Pennsylvania, 19139, United States

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    Austin, Texas, 78754, United States

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    Dallas, Texas, 75243, United States

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    DeSoto, Texas, 75115, United States

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    Houston, Texas, 77008, United States

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    Richmond, Virginia, 23298, United States

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    Roanoke, Virginia, 24014, United States

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    Zagreb, 10090, Croatia

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    Aichi, 470-1168, Japan

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    Kanagawa, 210-0013, Japan

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    Kumamoto, 861-0002, Japan

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    Kyoto, 625-8502, Japan

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    Nagano, 384-8540, Japan

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    Nagasaki, 856-0847, Japan

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    Nara, 634-8522, Japan

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    Osaka, 569-1041, Japan

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    Saga, 842-0192, Japan

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    Tokyo, 120-0033, Japan

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    Toyama, 939-8073, Japan

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    Guadalajara, 44340, Mexico

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    Monterrey, 64060, Mexico

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    Ponce, 00731, Puerto Rico

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    San Juan, 00926, Puerto Rico

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    Khot'kovo, 127025, Russia

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    Lipetsk, 399007, Russia

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    Moscow, 115522, Russia

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    Nizhny Novgorod, 603155, Russia

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    Saint Petersburg, 190121, Russia

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    Samara, 443016, Russia

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    Saratov, 410060, Russia

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    Tomsk, 634014, Russia

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    Voronezh, 394071, Russia

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    Yaroslavl, 150003, Russia

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    Goyang-si, 410-719, South Korea

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    Incheon, 400-711, South Korea

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    Naju, 520-833, South Korea

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    Seoul, 150-713, South Korea

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    Suwon, 442-723, South Korea

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    Yongin, 446-769, South Korea

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    Changhua, 50550, Taiwan

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    Neihu District, 114, Taiwan

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    Taipei, 100, Taiwan

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    Donetsk, 83037, Ukraine

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Kherson, 73488, Ukraine

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Kiev, 2660, Ukraine

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Vinnytsia, 21005, Ukraine

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