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Schizophrenia drug trial cut short: only 34 of 250 patients enrolled

NCT ID NCT05368558

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested cariprazine (VRAYLAR), an approved schizophrenia drug in the U.S., for people with acute schizophrenia in Japan and Taiwan. Participants received either cariprazine or a placebo for 6 weeks, then could continue on cariprazine for 18 more weeks. The trial was terminated early and enrolled only 34 adults instead of the planned 250, so the findings are limited.

What this could mean

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

Active substance
cariprazine (VRAYLAR)
What this could lead to
If successful, this could confirm cariprazine as a safe and effective option for managing acute schizophrenia symptoms in Asian populations.
What could go wrong
The trial was terminated early with only 34 participants enrolled, far below the planned 250. This limits the reliability of results and raises questions about feasibility or safety issues.

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

34 people

The number who actually took part.

Started

Aug 2022

Finished

Sep 2024

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: * Diagnosed with schizophrenia at least 1 year before informed consent. * Experienced a persistent psychotic episode within 2 months prior to informed consent requiring treatment modifications as judged by the investigator or sub-investigator. Exclusion Criteria: \- History of clinically significant medical conditions or any other reason that the investigator (or subinvestigator) determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study drug.

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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

  • Akita University Hospital /ID# 245941

    Akita, Akita, 010-8543, Japan

  • Asakayama General Hospital /ID# 242732

    Sakai, Osaka, 590-0018, Japan

  • Bali Psychiatric Center /ID# 241597

    New Taipei City, New Taipei, 249, Taiwan

  • Changhua Christian Hospital /ID# 241524

    Changhua City, Changhua County, 50006, Taiwan

  • Chung Shan Medical University Hospital /ID# 241543

    Taichung, 40201, Taiwan

  • Duplicate_Hokkaido University Hospital /ID# 243245

    Sapporo, Hokkaido, 060-8648, Japan

  • Duplicate_University Hospital Kyoto Prefectural University of Medicine /ID# 242443

    Kyoto, Kyoto, 602-8566, Japan

  • Fukuoka University Hospital /ID# 244404

    Fukuoka, Fukuoka, 814-0180, Japan

  • Gifu University Hospital /ID# 246238

    Gifu, Gifu, 501-1194, Japan

  • Goryokai Hospital /ID# 242420

    Sapporo, Hokkaido, 002-8029, Japan

  • Hayakawa Clinic /ID# 242432

    Kure, Hiroshima, 737-0111, Japan

  • Hizen Psychiatric Center /ID# 243239

    Kanzaki-gun, Saga-ken, 842-0192, Japan

  • Holy Cross Hospital /ID# 242673

    Toki-shi, Gifu, 509-5142, Japan

  • International University of Health and Welfare Narita Hospital /ID# 243870

    Narita-shi, Chiba, 2868520, Japan

  • Inuo Hospital /ID# 243310

    Tosu-shi, Saga-ken, 841-0081, Japan

  • Jianan Psychiatric Center, Ministry of Health and Welfare /ID# 241540

    Tainan, 71742, Taiwan

  • Juntendo Univ Koshigaya Hospital /ID# 248502

    Koshigaya-shi, Saitama, 343-0032, Japan

  • Kagawa University Hospital /ID# 243772

    Kita-gun, Kagawa-ken, 761-0793, Japan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 241528

    Kaohsiung City, 807, Taiwan

  • Kaohsiung Municipal Kai-Syuan Psychiatric Hospital /ID# 241533

    Kaohsiung City, Kaohsiung, 802, Taiwan

  • Kuramitsu Hospital /ID# 242511

    Fukuoka, Fukuoka, 819-0037, Japan

  • Linkou Chang Gung Memorial Hospital /ID# 241520

    Taoyuan City, 333, Taiwan

  • Maizuru Medical Center /ID# 243450

    Maizuru, Kyoto, 625-8502, Japan

  • Mental Support Soyokaze Hospital /ID# 242512

    Ueda-shi, Nagano, 386-0401, Japan

  • Mie University Hospital /ID# 244710

    Tsu, Mie-ken, 514-8507, Japan

  • Minamitoyama Nakagawa Hospital /ID# 243616

    Toyama, 939-8073, Japan

  • Nara Medical University Hospital /ID# 242561

    Kashihara-shi, Nara, 634-8522, Japan

  • Narimasu Kosei Hospital /ID# 243107

    Banqiao Qu, Tokyo, 175-0091, Japan

  • National Center of Neurology and Psychiatry /ID# 242677

    Kodaira-shi, Tokyo, 187-8551, Japan

  • National Hospital Organization Kure Medical Center /ID# 243405

    Kure-shi, Hiroshima, 737-0023, Japan

  • National Taiwan University Hospital - Yunlin Branch /ID# 241537

    Douliu, 640, Taiwan

  • New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical /ID# 243653

    New Taipei City, 236, Taiwan

  • Nishigahara Hospital /ID# 243312

    Kita-ku, Tokyo, 114-0024, Japan

  • Numazu Chuo Hospital /ID# 245275

    Numazu-shi, Shizuoka, 4108575, Japan

  • Ongata Hospital /ID# 256975

    Hachioji-shi, Tokyo, 192-0153, Japan

  • Rainbow & Sea Hospital /ID# 242699

    Karatsu-shi, Saga-ken, 847-0031, Japan

  • Sapporo Medical University Hospital /ID# 245135

    Sapporo, Hokkaido, 060-8543, Japan

  • Shin-abuyama Hospital /ID# 243138

    Takatsuki, 569-1041, Japan

  • Shiranui Hospital /ID# 243717

    Omuta-shi, Fukuoka, 836-0004, Japan

  • Taichung Veterans General Hospital /ID# 246200

    Taichung, 40705, Taiwan

  • Taipei City Hospital, Songde Branch /ID# 241600

    Taipei, 110, Taiwan

  • Taipei Veterans General Hospital /ID# 241522

    Taipei City, Taipei, 11217, Taiwan

  • Taniyama Hospital /ID# 242385

    Kagoshima, Kagoshima-ken, 891-0111, Japan

  • Taoyuan Psychiatric Center, MOHW /ID# 241691

    Taoyuan, 33058, Taiwan

  • Tochigi Prefectural Okamotodai Hospital /ID# 248855

    Utsunomiya, Tochigi, 329-1104, Japan

  • Tokushima University Hospital /ID# 250056

    Tokushima, Tokushima, 770-8503, Japan

  • Tokyo Metropolitan Matsuzawa Hospital /ID# 245272

    Setagaya-ku, Tokyo, 156-0057, Japan

  • Tri-Service General Hospital Beitou Branch /ID# 241563

    Taipei, 112, Taiwan

  • TsaoTun Psychiatric Center, MOHW /ID# 246012

    Nantou City, 54249, Taiwan

  • Wakayama Medical University Hospital /ID# 251105

    Wakayama, Wakayama, 641-8510, Japan

  • Yokohama City University Hospital /ID# 244944

    Yokohama, Kanagawa, 236-0004, Japan

  • Yuge Hospital /ID# 242849

    Kumamoto, Kumamoto, 861-8002, Japan

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