Brexpiprazole in Patients With Acute Schizophrenia

Schizophrenia Clinical Trial

Official title:

Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-reference, Flexible-dose Study of Brexpiprazole in Patients With Acute Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01810380
• Other study ID #: 14644A
• Secondary ID: 2012-002252-17
• Status: Completed
• Phase: Phase 3
• First received: March 11, 2013
• Last updated: February 5, 2015
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Estonia: The State Agency of MedicineFrance: Agence Nationale de Sécurité du Médicament et des produits de santéPoland: National Institute of MedicinesRussia: Ministry of Health of the Russian FederationSerbia: Medicines and Medical Devices AgencyUkraine: State Pharmacological Center - Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Placebo
Once daily as tablets and capsules, orally
• Brexpiprazole
Up to 4 mg/day, once daily, tablets, orally
• Quetiapine extended release
Up to 800 mg/day, once daily, encapsulated tablets, orally

Locations

Country	Name	City	State
United States	US009	Escondido	California

Sponsors (2)

Lead Sponsor	Collaborator
H. Lundbeck A/S	Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in efficacy using PANSS	Positive and Negative Syndrome Scale (PANSS) total score	Baseline and Week 6	No
Secondary	Change from baseline in clinical global impression	Clinical Global Impression - Severity of Illness (CGI-S) score	Baseline and Week 6	No
Secondary	Improvement of clinical global impression	Clinical Global Impression - Global Improvement (CGI-I) score	Week 6	No
Secondary	Change from baseline in psychotic symptoms	PANSS Positive Subscale score	Baseline and Week 6	No
Secondary	Change from baseline in psychotic symptoms	PANSS Negative Subscale score	Baseline and Week 6	No
Secondary	Change from baseline in psychotic symptoms	PANSS Excited Component score	Baseline and Week 6	No
Secondary	Change from baseline in psychotic symptoms	PANSS Marder Factor scores	Baseline and Week 6	No
Secondary	Response rate	Based on pre-specified reduction in PANSS total score or CGI-I score	Baseline and Week 6	No
Secondary	Change from baseline in personal and social performance	Personal and Social Performance Scale (PSP) score	Baseline and Week 6	No
Secondary	Safety and tolerability	Number of adverse events	Up to 6 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP) for patients who do not enter the follow-up study 14644B	Yes
Secondary	Risk of suicidality	Columbia-Suicide Severity Rating Scale (C-SSRS) score	Up to 6 weeks	Yes