Brexpiprazole in Patients With Schizophrenia

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Brexpiprazole

• Registration Number: NCT01810783
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

To determine the safety and efficacy of brexpiprazole during long-term treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-12
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-14
• Study Start: 2013-07
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2016-12-30
• Results First Submitted QC: 2016-12-30
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Results First Posted: 2017-02-23
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• The patient has completed the lead-in study 14644A.
• The patient is judged to potentially benefit from 52-week treatment with brexpiprazole according to the clinical opinion of the investigator.
• The patient agrees to protocol-defined use of effective contraception.

Exclusion Criteria

• The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14644A.
• The patient has a clinically significant unstable illness diagnosed during Study 14644A.
• 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 an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant.
• 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brexpiprazole	Brexpiprazole	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability	Up to 52 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP)	Number of treatment-emergent adverse events (TEAEs)

Trial Locations

Locations (48)

US010; 🇺🇸 Anaheim, California, United States

US020; 🇺🇸 Cerritos, California, United States

US009; 🇺🇸 Escondido, California, United States

US022; 🇺🇸 Garden Grove, California, United States

US018; 🇺🇸 Long Beach, California, United States

US011; 🇺🇸 San Diego, California, United States

US021; 🇺🇸 Washington, District of Columbia, United States

US004; 🇺🇸 Kissimmee, Florida, United States

US015; 🇺🇸 North Miami, Florida, United States

US019; 🇺🇸 Lake Charles, Louisiana, United States

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