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Aripiprazole Once-monthly in Patients With Schizophrenia

Information source: H. Lundbeck A/S
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Aripiprazole once-monthly (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: H. Lundbeck A/S

Official(s) and/or principal investigator(s):
Email contact via H. Lundbeck A/S, Study Director, Affiliation: LundbeckClinicalTrials@lundbeck.com

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.

Clinical Details

Official title: Interventional, Open-label, Flexible-dose Extension Study of Aripiprazole Once-monthly in Patients With Schizophrenia

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Safety and tolerability

Risk of suicidality

Secondary outcome:

Mean change from Baseline in subjective well-being using SWN-S

Mean change from Baseline in clinical global impression

Mean change from Baseline in quality of life

Mean change from Baseline in quality of life using QLS

Mean change from Baseline in tolerability and quality of life using TooL

Mean change from Baseline to identify individuals with sexual dysfunction

Mean change from Baseline in the patient's readiness to work

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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.

Locations and Contacts

US006, San Diego, California 92102, United States
Additional Information

Starting date: October 2013
Last updated: May 8, 2015

Page last updated: August 20, 2015

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