Phase 3
N=88
Aripiprazole Once-monthly in Patients With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01959035 ↗Enrolled (actual)
88
Serious AEs
3.4%
Results posted
May 2016
Primary outcome: Primary: Safety and Tolerability — 65 number of events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aripiprazole once-monthly (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- H. Lundbeck A/S
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability |
65 | — |
| SECONDARY Change From Baseline to Week 24 in SWN-S Total Score |
0.19 | — |
| SECONDARY Change From Baseline to Week 24 in CGI-S Score |
-0.10 | — |
| SECONDARY Change From Baseline to Week 24 in QLS Total Score |
2.32 | — |
| SECONDARY Change From Baseline to Week 24 in the 'Common Objects and Activities' QLS Domain Score |
0.21 | — |
| SECONDARY Change From Baseline to Week 24 in the 'Intrapsychic Foundations' QLS Domain Score |
0.72 | — |
| SECONDARY Change From Baseline to Week 24 in the 'Interpersonal Relations' QLS Domain Score |
0.58 | — |
| SECONDARY Change From Baseline to Week 24 in the 'Instrumental Role' QLS Domain Score |
0.42 | — |
| SECONDARY Change From Baseline to Week 24 in the TooL Total Score |
-0.47 | — |
| SECONDARY Change From Baseline to Week 24 in the WoRQ Total Score |
-0.53 | — |
| SECONDARY Change From Baseline to Week 24 in ASEX Total Score |
-0.42 | — |
| SECONDARY Patients Categorised As Sexually Dysfunctional Measured at Week 24 on the ASEX Scale |
31 | — |
| SECONDARY Change From Baseline to Week 12 in SWN-S Total Score |
-1.57 | — |
| SECONDARY Change From Baseline to Week 12 in CGI-S Score |
0.00 | — |
| SECONDARY Change From Baseline to Week 12 in QLS Total Score |
2.08 | — |
| SECONDARY Change From Baseline to Week 12 in the 'Common Objects and Activities' QLS Domain Score |
0.10 | — |
| SECONDARY Change From Baseline to Week 12 in the 'Intrapsychic Foundations' QLS Domain Score |
0.73 | — |
| SECONDARY Change From Baseline to Week 12 in the 'Interpersonal Relations' QLS Domain Score |
0.67 | — |
| SECONDARY Change From Baseline to Week 12 in the 'Instrumental Role' QLS Domain Score |
0.02 | — |
| SECONDARY Change From Baseline to Week 12 in the TooL Total Score |
-0.16 | — |
| SECONDARY Change From Baseline to Week 12 in the WoRQ Total Score |
-0.55 | — |
| SECONDARY Change From Baseline to Week 12 in ASEX Total Score |
-0.74 | — |
| SECONDARY Patients Categorised As Sexually Dysfunctional Measured at Week 12 on the ASEX Scale |
32 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01959035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.