Aripiprazole Once-monthly in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Interventional, Open-label, Flexible-dose Extension Study of Aripiprazole Once-monthly in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959035
• Other study ID #: 14724B
• Secondary ID: 2012-003239-47
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2013
• Last updated: May 8, 2015
• Start date: October 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• 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 MedicineItaly: The Italian Medicines AgencySpain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products AgencyUnited States: Food and Drug AdministrationCanada: Health CanadaFrance: Ministry of HealthGermany: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To obtain information on the safety, tolerability and effectiveness of aripiprazole once-monthly in a manner consistent with its intended use in everyday clinical practice in patients with schizophrenia who completed Study 14724A / NCT01795547.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Patients will be recruited among those who complete treatment with aripiprazole in Study 14724A / NCT01795547.

Inclusion Criteria:

• The patient is judged to potentially benefit from 24-week treatment with aripiprazole once-monthly 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 14724A / NCT01795547.

• The patient has a clinically significant unstable illness diagnosed during Study 14724A / NCT01795547.

• The patient is at significant risk of harming himself/herself or others according to the investigator's judgement or according to Columbia-Suicide Severity Rating Scale (C-SSRS).

• The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability or efficacy, or interfere with the conduct or interpretation of the study.

• The patient has one or more clinical laboratory test values outside the reference range, based on the blood or urine samples taken during the conduct of Study 14724A / NCT01795547 that are, in the investigator's opinion, of potential risk to the patient's safety.

• 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:
• Aripiprazole once-monthly
400 or 300 mg/month; 6 intramuscular (IM) injections starting at Baseline

Locations

Country	Name	City	State
United States	US006	San Diego	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 24 weeks and 4-week safety follow up	Yes
Primary	Risk of suicidality	Columbia-Suicide Severity Rating Scale (C-SRRS) score	Up to 24 weeks and 4-week safety follow up	Yes
Secondary	Mean change from Baseline in subjective well-being using SWN-S	Subjective Well-being under Neuroleptics - short version (SWN-S) total score	Baseline and Week 24	No
Secondary	Mean change from Baseline in clinical global impression	Clinical Global Impression - Severity of Illness (CGI-S) score	Baseline and Week 24	No
Secondary	Mean change from Baseline in quality of life	Quality of Life Scale (QLS) total score	Baseline and Week 24	No
Secondary	Mean change from Baseline in quality of life using QLS	4 QLS dimension scores	Baseline and Week 24	No
Secondary	Mean change from Baseline in tolerability and quality of life using TooL	Tolerability and Quality of Life (TooL) total score	Baseline and Week 24	No
Secondary	Mean change from Baseline to identify individuals with sexual dysfunction	Arizona Sexual Experience Scale (ASEX) total score	Baseline and Week 24	No
Secondary	Mean change from Baseline in the patient's readiness to work	The Readiness for Work Questionnaire (WoRQ) total score	Baseline and Week 24	No