Brexpiprazole in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Interventional, Open-label, Flexible-dose Extension Study of Brexpiprazole in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01810783
• Other study ID #: 14644B
• Secondary ID: 2012-002705-21
• Status: Completed
• Phase: Phase 3
• First received: March 12, 2013
• Last updated: January 18, 2016
• Start date: July 2013

Study information

• Verified date: January 2016
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlEstonia: The State Agency of MedicineFrance: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Agency for Medicines and Medical DevicesRussia: Ministry of Health of the Russian FederationSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSlovakia: State Institute for Drug ControlUkraine: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Brexpiprazole
1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).

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	Safety and tolerability	Number of adverse events	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)	Yes
Secondary	Change from baseline in psychotic symptoms	Positive and Negative Syndrome Scale (PANSS) total score. The PANSS is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS includes 30 items. As this was an open-label study, all outcomes should be considered as exploratory outcomes.	Baseline and Week 52	No
Secondary	Change from baseline in psychotic symptoms	PANSS Positive Subscale score. The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Positive Subscale score is calculated from 7 items (for example: delusions, conceptual disorganization and hallucinatory behaviour). As this was an open-label study, all outcomes should be considered as exploratory outcomes.	Baseline and Week 52	No
Secondary	Change from baseline in psychotic symptoms	PANSS Negative Subscale score. The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Negative Subscale score is calculated from 7 items (for example: blunted affect, emotional withdrawal and poor rapport). As this was an open-label study, all outcomes should be considered as exploratory outcomes.	Baseline and Week 52	No
Secondary	Change from baseline in psychotic symptoms	PANSS Excited Component score. The PANSS is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Excited Component score is calculated from 5 items (for example: poor impulse control, tension and hostility). As this was an open-label study, all outcomes should be considered as exploratory outcomes.	Baseline and Week 52	No
Secondary	Change from baseline in psychotic symptoms	PANSS Marder Factor scores. The PANSS Marder Factor scores: positive symptoms is calculated from 8 items (for example: delusions, conceptual disorganization and stereotype thinking). The PANSS Marder Factor scores: negative symptoms is calculated from 7 items (for example: blunted affect, emotional withdrawal and motor retardation). The PANSS Marder Factor scores: disorganized thoughts is calculated from 7 items (for example: conceptual disorganization, difficulty in abstract thinking and mannerisms and posturing). The PANSS Marder Factor scores: uncontrolled hostility/excitement is calculated from 4 items (for example: excitement, hostility, and uncooperativeness). The PANSS Marder Factor scores: anxiety/depression is calculated from 4 items (for example: anxiety, guilt feelings, and tension). As this was an open-label study, all outcomes should be considered as exploratory outcomes.	Baseline and Week 52	No
Secondary	Change from baseline in clinical global impression	Clinical Global Impression - Severity of Illness (CGI-S) score. The CGI-S provides the clinician's impression of the patient's current state of mental illness.; The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). As this was an open-label study, all outcomes should be considered as exploratory outcomes.	Baseline and Week 52	No
Secondary	Improvement of clinical global impression	Clinical Global Impression - Global Improvement (CGI-I) score. The CGI-I provides the clinician's impression of the patient's improvement (or worsening).; The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. As this was an open-label study, all outcomes should be considered as exploratory outcomes.	Week 52	No
Secondary	Response rate	The response rate was defined as a reduction of =30% from baseline in PANSS total score OR a CGI-I score of 1 or 2. As this was an open-label study, all outcomes should be considered as exploratory outcomes.	Baseline and Week 52	No
Secondary	Change from baseline in personal and social performance	Personal and Social Performance scale (PSP). The PSP is a clinician-rated scale designed and validated to measure a patient's current level of social functioning. The PSP consists of 4 items: socially useful activities (including work and study), personal and social relationships, self-care, and disturbing and aggressive behaviours. The 4 items are assessed on a 6-point scale, from absent to very severe. Based on these assessments and their combination, the total score ranges from 1 to 100. As this was an open-label study, all outcomes should be considered as exploratory outcomes.	Baseline and Week 52	No