Clinical trial NCT01959035: Aripiprazole Once-monthly in Patients With Schizophrenia
Official title: Interventional, Open-label, Flexible-dose Extension Study of Aripiprazole Once-monthly in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2013-10-09
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety and Tolerability
timeFrame: Up to 24 weeks and 4-week safety follow up
Secondary outcomes:
measure: Change From Baseline to Week 24 in SWN-S Total Score
timeFrame: Baseline and Week 24
measure: Change From Baseline to Week 24 in CGI-S Score
timeFrame: Baseline and Week 24
measure: Change From Baseline to Week 24 in QLS Total Score
timeFrame: Baseline and Week 24
measure: Change From Baseline to Week 24 in the 'Common Objects and Activities' QLS Domain Score
timeFrame: Baseline and Week 24
measure: Change From Baseline to Week 24 in the 'Intrapsychic Foundations' QLS Domain Score
timeFrame: Baseline and Week 24
measure: Change From Baseline to Week 24 in the 'Interpersonal Relations' QLS Domain Score
timeFrame: Baseline and Week 24
measure: Change From Baseline to Week 24 in the 'Instrumental Role' QLS Domain Score
timeFrame: Baseline and Week 24
measure: Change From Baseline to Week 24 in the TooL Total Score
timeFrame: Baseline and Week 24
measure: Change From Baseline to Week 24 in the WoRQ Total Score
timeFrame: Baseline and Week 24
measure: Change From Baseline to Week 24 in ASEX Total Score
timeFrame: Baseline and Week 24
measure: Patients Categorised As Sexually Dysfunctional Measured at Week 24 on the ASEX Scale
timeFrame: Week 24
measure: Change From Baseline to Week 12 in SWN-S Total Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in CGI-S Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in QLS Total Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in the 'Common Objects and Activities' QLS Domain Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in the 'Intrapsychic Foundations' QLS Domain Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in the 'Interpersonal Relations' QLS Domain Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in the 'Instrumental Role' QLS Domain Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in the TooL Total Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in the WoRQ Total Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in ASEX Total Score
timeFrame: Baseline and Week 12
measure: Patients Categorised As Sexually Dysfunctional Measured at Week 12 on the ASEX Scale
timeFrame: Week 12
Other outcomes:
Locations:
city: San Diego
country: United States
facility: US006
state: California
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: