Schizophrenia MedDRA version: 16.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Lu AF41155
Product Code: OPC-14597
Pharmaceutical Form: Powder and solvent for prolonged-release suspension for injection
INN or Proposed INN: ARIPIPRAZOLE
CAS Number: 129722-12-9
Concen
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Long-term safety and tolerability of aripiprazole once-monthly (400 or 300 mg/month) in patients with schizophrenia who completed Study 14724A.;Secondary Objective: - Effectiveness of aripiprazole once-monthly (400 or 300 mg/month) over a period of 24 weeks on subjective treatment satisfaction in patients with schizophrenia who completed Study 14724A. - Effectiveness of aripiprazole once-monthly (400 or 300 mg/month) over a period of 24 weeks on clinical global impression in patients with schizophrenia who completed Study 14724A. - Effectiveness of aripiprazole once-monthly (400 or 300 mg/month) over a period of 24 weeks on health-related quality of life in patients with schizophrenia who completed Study 14724A.;Primary end point(s): Primary Outcome Measure: • Safety and tolerability measured with number of adverse events • Risk of suicidality measured with Columbia-Suicide Severity Rating Scale (C-SRRS) score;Timepoint(s) of evaluation of this end point: Up to 24 weeks and 4-week safety follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Mean change from Baseline in subjective well-being using SWN-S measured with Subjective Well-being under Neuroleptics - short version (SWN-S) total score • Mean change from Baseline in clinical global impression measured with Clinical Global Impression - Severity of Illness (CGI-S) score • Mean change from Baseline in quality of life measured with Quality of Life Scale (QLS) total score • Mean change from Baseline in quality of life using QLS measured with 4 QLS dimension scores • Mean change from Baseline in tolerability and quality of life using TooL measured with Tolerability and Quality of Life (TooL) total score • Mean change from Baseline to identify individuals with sexual dysfunctionmeasured with Arizona Sexual Experience Scale (ASEX) total score • Mean change from Baseline in the patient's readiness to work measured with The Readiness for Work Questionnaire (WoRQ) total score;Timepoint(s) of evaluation of this end point: Baseline and Week 24 | — |
Countries
Canada, Czech Republic, Estonia, France, Germany, Italy, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed