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Acute SchizophreniaPhase 3EQUATORNCT01668797

Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia

A Phase 3 study testing Brexpiprazole in people with Acute Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 49 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo as maintenance treatment in adults with schizophrenia. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Acute Schizophrenia
What is being tested?
Brexpiprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
524 participants
Where
49 sitesin 8 countries
Study dates
Oct 2012to Feb 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients age 18 years or older to less than 65 years, inclusive (at time of informed consent)
  • Subjects with a current diagnosis of schizophrenia, as defined by DSM-IV-TR criteria and a history of the illness for at least three years prior to screening (as per subject, family, healthcare provider, or by previous medical records).
  • Subjects with a stable living environment, as demonstrated by the ability to provide contact information for themselves and/or family/friend(s)/caregiver(s).
  • Subjects who showed previous response to antipsychotic treatment in the past year.
  • Subjects who are currently treated with oral or depot antipsychotics other than clozapine or who have had a recent lapse in antipsychotic treatment requiring chronic treatment with antipsychotic medication for stabilization.
  • Subjects who are experiencing a current acute exacerbation of psychotic symptoms requiring stabilization
  • Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.

Who cannot join

  • Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
  • Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator
  • Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
  • Subjects experiencing acute depressive symptoms within the past 30 days
  • Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history
  • Subjects with a significant risk of violent behavior; who represent a risk of committing suicide
  • Subjects with clinically significant tardive dyskinesia
  • Subjects currently treated with insulin for diabetes.

Trial locations and contacts

49 sites in 8 countries.

49 sites in 8 countries

United States14 sites

  • Study site

    Anaheim, California, 92805

  • Study site

    Cerritos, California, 90703

  • Study site

    Dallas, Texas, 75231

  • Study site

    Garden Grove, California, 92845

  • Study site

    Hoffman Estates, Illinois, 60169

  • Study site

    Las Vegas, Nevada, 89102

  • Study site

    Memphis, Tennessee, 38119

  • Study site

    North Platte, Nebraska, 69101

  • Study site

    Richmond, Virginia, 23230

  • Study site

    Saint Charles, Missouri, 63304

  • Study site

    San Diego, California, 92102

  • Study site

    San Diego, California, 92103

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Tampa, Florida, 33613

Other trials in United States

Romania8 sites

  • Study site

    Arad, 310022

  • Study site

    Brasov, 500123

  • Study site

    Bucharest, 041914

  • Study site

    Craiova, 200473

  • Study site

    Focşani, 620165

  • Study site

    Iași, 700282

  • Study site

    Piteşti, 110069

  • Study site

    Targoviste, 130086

Other trials in Romania

Ukraine8 sites

  • Study site

    Kharkiv, 61036

  • Study site

    Kharkiv, 61068

  • Study site

    Kherson,Vil. Stepanivka, 73488

  • Study site

    Kyiv, 02660

  • Study site

    Kyiv, 04080

  • Study site

    Lviv, 79021

  • Study site

    Odesa, 65014

  • Study site

    Simferopol, 95006

Other trials in Ukraine

Malaysia5 sites

  • Study site

    Kajang, Selangor, 43000

  • Study site

    Kota Bharu, Kelantan, 15586

  • Study site

    Kuala Lumpur, Kuala Lumpur, 56000

  • Study site

    Kuala Lumpur, Kuala Lumpur, 59100

  • Study site

    Sabak Bernam, 88815

Other trials in Malaysia

Serbia5 sites

  • Study site

    Belgrade, 11000

  • Study site

    Belgrade, 11040

  • Study site

    Kragujevac, 34000

  • Study site

    Novi Kneževac, 23330

  • Study site

    Novi Sad, 21000

Other trials in Serbia

Colombia4 sites

  • Study site

    Barranquilla, 00000

  • Study site

    Bello, 00000

  • Study site

    Bogotá, 00000

  • Study site

    Pereira, 00000

Other trials in Colombia

Turkey (Türkiye)3 sites

  • Study site

    Denizli, 20070

  • Study site

    Diyarbakır, 21280

  • Study site

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Puerto Rico2 sites

  • Study site

    San Juan, 00918

  • Study site

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia

The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo as maintenance treatment in adults with schizophrenia.

Read the detailed description

Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the world population. Hallucinations and delusions are the most striking characteristic positive symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and lack of emotion, energy, and motivation) may also be present. The first antipsychotics developed for the treatment of schizophrenia were effective against positive symptoms, but showed little efficacy for negative symptoms and were also associated with a high incidence of side effects. Second generation antipsychotics, represent a significant advancement in the treatment of psychotic disorders because they are effective and at the same time exhibit fewer side effects than first generation antipsychotics. Although generally safer than first generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these drugs vary considerably.

Being tested
Brexpiprazole, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrexpiprazoleDrug

    Brexpiprazole tablets 1 to 4 mg /day

  • PlaceboDrug

    Placebo comparator for 52 weeks

Study groups in NCT01668797
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo comparator for 52 weeks
Receives: Drug: Placebo
Brexpiprazole (OPC-34712)ExperimentalBrexpiprazole (OPC-34712) for 52 weeks
Receives: Drug: Brexpiprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse in Phase C.

    The primary efficacy variable was time to impending relapse from randomization, as assessed by Clinical Global Impression of Improvement (CGI-I) score ≥5, Positive and Negative Syndrome Scale (PANSS) scores for hostility or uncooperativeness ≥5, or ≥20% increase in PANSS Total Score. Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score >4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content).OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of "yes" to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.The measure type, number is Hazard Ratio.

    Measured: From randomization to time of exacerbation of psychotic symptoms/impending relapse - up to 52 weeks

Secondary outcomes (1)

  1. Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria in the Double-blind Maintenance Phase

    Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or an increase on any of the following individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual though content) to a score of >4 and an absolute increase of ≥ 4 on the combined 4 PANSS items. OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Current suicidal behavior as assessed by the C-SSRS (ie, an answer of "yes" to any of the questions on the suicidal behavior section of the C-SSRS 5) Violent or aggressive behavior resulting in clinically significant self-injury to another person, or property damage.

    Measured: Baseline and Week 52/Early Termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionJan 2015
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
524 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01668797
Sponsor's protocol ID
331-10-232
Other IDs
2011-005766-38
Acronym
EQUATOR
Status last verified
Nov 2016
First submitted
16 Aug 2012
Last updated
13 Jan 2017
Data monitoring committee
Yes

Publications

  • Correll CU, He Y, Therrien F, MacKenzie E, Meehan SR, Weiss C, Hefting N, Hobart M. Effects of Brexpiprazole on Functioning in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies. J Clin Psychiatry. 2022 Mar 1;83(2):20m13793. doi: 10.4088/JCP.20m13793.

    PubMed 35235720

  • Marder SR, Meehan SR, Weiss C, Chen D, Hobart M, Hefting N. Effects of Brexpiprazole Across Symptom Domains in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies. Schizophr Bull Open. 2021 May 1;2(1):sgab014. doi: 10.1093/schizbullopen/sgab014. eCollection 2021 Jan.

    PubMed 34901863

  • Correll CU, Shi L, Weiss C, Hobart M, Eramo A, Duffy RA, Weiller E, Baker RA. Successful switching of patients with acute schizophrenia from another antipsychotic to brexpiprazole: comparison of clinicians' choice of cross-titration schedules in a post hoc analysis of a randomized, double-blind, maintenance treatment study. CNS Spectr. 2019 Oct;24(5):507-517. doi: 10.1017/S1092852918001086.

    PubMed 30306884

  • Fleischhacker WW, Hobart M, Ouyang J, Forbes A, Pfister S, McQuade RD, Carson WH, Sanchez R, Nyilas M, Weiller E. Efficacy and Safety of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults with Schizophrenia: a Randomized, Double-Blind, Placebo-Controlled Study. Int J Neuropsychopharmacol. 2017 Jan 1;20(1):11-21. doi: 10.1093/ijnp/pyw076.

    PubMed 27566723

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Brexpiprazole in people with Acute Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 49 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Romania, Ukraine, Malaysia, Serbia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse in Phase C. (time frame: From randomization to time of exacerbation of psychotic symptoms/impending relapse - up to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01668797, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.

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