Schizophrenia Clinical Trial
Official title:
Interventional, Open-label, Flexible-dose Extension Study of Aripiprazole Once-monthly in Patients With Schizophrenia
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.
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. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | US006 | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
H. Lundbeck A/S | Otsuka Pharmaceutical Co., Ltd. |
United States,
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 |
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