Clinical trial NCT01810380: Brexpiprazole in Patients With Acute Schizophrenia
Official title: Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-reference, Flexible-dose Study of Brexpiprazole in Patients With Acute Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2013-03-13
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline to Week 6 in PANSS Total Score
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Change From Baseline to Week 6 in CGI-S Score
timeFrame: Baseline and Week 6
measure: CGI-I Score at Week 6
timeFrame: Week 6
measure: Change From Baseline to Week 6 in PANSS Positive Subscale Score
timeFrame: Baseline and Week 6
measure: Change From Baseline to Week 6 in PANSS Negative Subscale Score
timeFrame: Baseline and Week 6
measure: Change From Baseline to Week 6 in PANSS General Psychopathology Subscale Score
timeFrame: Baseline and Week 6
measure: Change From Baseline to Week 6 in PANSS Excited Component Score
timeFrame: Baseline and Week 6
measure: Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms
timeFrame: Baseline and Week 6
measure: Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms
timeFrame: Baseline and Week 6
measure: Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thoughts
timeFrame: Baseline and Week 6
measure: Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement
timeFrame: Baseline and Week 6
measure: Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety/Depression
timeFrame: Baseline and Week 6
measure: Discontinuation Due to Lack of Efficacy During the Study
timeFrame: Baseline to Week 6
measure: Response Rate at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline to Week 6 in PSP Total Score
timeFrame: Baseline and Week 6
measure: PSP Functional Remission Rate at Week 6
timeFrame: Week 6
measure: PSP Functional Response Rate at Week 6
timeFrame: Week 6
measure: PSP Domain D: Disturbing and Aggressive Behaviours at Week 6
timeFrame: Week 6
Other outcomes:
Locations:
city: Escondido
country: United States
facility: US009
state: California
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.