Aripiprazole Once-monthly in Patients With Schizophrenia

NCT01959035 | Completed Phase 3 Results

• 2 other identifiers: 14724B2012-003239-47
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  Number of treatment emergent adverse events (TEAEs).

  Up to 24 weeks and 4-week safety follow up

Secondary Outcomes (22)

• Change From Baseline to Week 24 in SWN-S Total Score

  Baseline and Week 24

• Change From Baseline to Week 24 in CGI-S Score

  Baseline and Week 24

• Change From Baseline to Week 24 in QLS Total Score

  Baseline and Week 24

• Change From Baseline to Week 24 in the 'Common Objects and Activities' QLS Domain Score

  Baseline and Week 24

• Change From Baseline to Week 24 in the 'Intrapsychic Foundations' QLS Domain Score

  Baseline and Week 24

Study Arms (1)

Aripiprazole once-monthly

EXPERIMENTAL

Drug: Aripiprazole once-monthly

Interventions

Aripiprazole once-monthly DRUG

400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline

Also known as: Abilify Maintena®

Aripiprazole once-monthly

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

US006

San Diego, California, 92102, United States

Location

Related Links

• EMA EudraCT Results: 2012-003239-47

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: H. Lundbeck
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@Lundbeck.com

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 9, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 17, 2017
• Results First Posted: May 16, 2016

Record last verified: 2017-02

Locations

US (1)