Brexpiprazole in Patients With Acute Schizophrenia

NCT01810380 | Completed Phase 3 Results

• 2 other identifiers: 14644A2012-002252-17
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 6 in PANSS Total Score

  The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms.

  Baseline and Week 6

Secondary Outcomes (17)

• Change From Baseline to Week 6 in CGI-S Score

  Baseline and Week 6

• CGI-I Score at Week 6

  Week 6

• Change From Baseline to Week 6 in PANSS Positive Subscale Score

  Baseline and Week 6

• Change From Baseline to Week 6 in PANSS Negative Subscale Score

  Baseline and Week 6

• Change From Baseline to Week 6 in PANSS General Psychopathology Subscale Score

  Baseline and Week 6

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Brexpiprazole

EXPERIMENTAL

Patients randomised to brexpiprazole received 1mg/day on Day 1, 2mg/day on Day 2, 3mg/day on Day 3 (uptitration); the dose could be adjusted from Day 4 onwards to 2, 3, or 4mg/day to optimise the clinical effect and tolerability.

Drug: Brexpiprazole

Quetiapine extended release

OTHER

Active Reference. Patients randomised to quetiapine received 300mg/day on Day 1, 600mg/day on Days 2 and 3 (uptitration); the dose could be adjusted from Day 4 onwards to 400, 600, or 800mg/day to optimise the clinical effect and tolerability.

Drug: Quetiapine extended release

Interventions

Placebo DRUG

Once daily as tablets and capsules, orally

Placebo

Brexpiprazole DRUG

2-4 mg/day, once daily, tablets, orally

Brexpiprazole

Quetiapine extended release DRUG

400-800 mg/day, once daily, encapsulated tablets, orally

Also known as: Seroquel XL®/XR®

Quetiapine extended release

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has schizophrenia, diagnosed according to DSM-IV-TR™ and confirmed by the Mini International Neuropsychiatric Interview (MINI).
• The patient has an acute exacerbation of psychotic symptoms and marked deterioration of usual function.
• The patient is willing to be hospitalised from the Screening Visit through Week 6.
• The patient will benefit from hospitalisation or continued hospitalisation for treatment of a current acute relapse of schizophrenia at study entry.
• The patient has a history of relapse and/or exacerbation of symptoms when not receiving antipsychotic treatment, excluding the current episode.
• The patient agrees to protocol-defined use of effective contraception.

You may not qualify if:

• The patient has a current Axis I diagnosis (DSM-IV-TR™ criteria) other than schizophrenia established as primary diagnosis.
• The patient suffers from a current Axis II diagnosis (DSM-IV-TR™ criteria).
• The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
• The patient, in the opinion of the investigator or according to Columbia Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
• The patient has clinically significant tardive dyskinesia or severe akathisia at enrolment.
• The patient has a history of neuroleptic malignant syndrome.
• The patient has any relevant medical history or current presence of systemic disease.
• The patient has, at the Screening Visit an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant.
• The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for \>5 years prior to the first dose of brexpiprazole.
• The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Sponsors & Collaborators

• H. Lundbeck A/S: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

US009

Escondido, California, 92025, United States

Location

Related Publications (4)

• Ismail Z, Kapadia S, Palma AM, Yildirim M, Farovik A. Brexpiprazole for anxiety symptoms in schizophrenia: a pooled analysis of short- and long-term trials. Curr Med Res Opin. 2025 Aug;41(8):1535-1548. doi: 10.1080/03007995.2025.2552286. Epub 2025 Sep 11.

  PMID: 40859756 DERIVED

• Ismail Z, Meehan SR, Farovik A, Kapadia S, Palma AM, Zhang Z, McIntyre RS. Effects of brexpiprazole on patient life engagement in schizophrenia: post hoc analysis of Positive and Negative Syndrome Scale data. Curr Med Res Opin. 2025 Jan;41(1):145-153. doi: 10.1080/03007995.2024.2440059. Epub 2025 Jan 3.

  PMID: 39749727 DERIVED

• 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.

  PMID: 35235720 DERIVED

• 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.

  PMID: 34901863 DERIVED

Related Links

• EMA EudraCT Results: 2012-002252-17

MeSH Terms

Conditions

Schizophrenia

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Email contact via
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@Lundbeck.com

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 13, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 16, 2017
• Results First Posted: March 29, 2016

Record last verified: 2017-02

Locations

US (1)