NCT01001702

Brief Summary

The purpose of this study is to test the long-term safety and tolerability of oral aripiprazole in adolescent patients with schizophrenia.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_3 schizophrenia

Geographic Reach
6 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 27, 2013

Completed
Last Updated

September 27, 2013

Status Verified

July 1, 2013

Enrollment Period

6.3 years

First QC Date

October 22, 2009

Results QC Date

July 29, 2013

Last Update Submit

July 29, 2013

Conditions

Schizophrenia

Keywords

Open LabelAripiprazole

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths

    An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject. Change in clinical relevance (severity increased) was entered as a new AE in the current trial. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (clinically significant) change from baseline for that individual subject. An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention. Additional information about Adverse Events can be found in the Adverse Event section.

    Up to 72 months

Secondary Outcomes (7)

  • Change From Baseline in Clinical Global Impression Severity of Illness (CGI-S) Score

    Baseline, Last Visit (Up to 72 Months)

  • Number of Participants With Clinical Significant Laboratory Tests

    Baseline, Up to 72 Months

  • Number of Participants With Clinically Significant Heart Rate

    Baseline, Up to 72 months

  • Number of Participants With Clinically Significant Blood Pressure

    Baseline, Up to 72 months

  • Number of Participants With Clinically Abnormal Changes in Electrocardiograms (ECGs) Evaluations

    Baseline, Up to 72 months

  • +2 more secondary outcomes

Study Arms (1)

Oral Aripiprazole

EXPERIMENTAL

Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.

Drug: Aripiprazole

Interventions

AripiprazoleDRUG

Flexible dose between 5 mg and 30 mg Aripiprazole tablets.

Also known as: ABILIFY®
Oral Aripiprazole

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subjects with a confirmed Axis I Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia who must have completed Otsuka study 31-03-241 (NCT00102518) treatment of adolescent subjects with schizophrenia

You may not qualify if:

  • Patients with a co-morbid serious, uncontrolled systemic illness
  • Patients with a significant risk of committing suicide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Study site

Buenos Aires, Argentina

Location

Study site

Mendoza, Argentina

Location

Study site

Split, Croatia

Location

Study site

Hyderabad, India

Location

Study site

Ludhiana, India

Location

Study site

Mumbai, India

Location

Study site

Tamilnadu, India

Location

Study site

Moscow, Russia

Location

Study site

Rostov-on-Don, Russia

Location

Study site

Saint Petersburg, Russia

Location

Study site

Yaroslavl, Russia

Location

Study site

Belgrade, Serbia

Location

Study site

Novi Sad, Serbia

Location

Study site

Kharkiv, Ukraine

Location

Study site

Kiev, Ukraine

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Global Medical Affair
Organization
Otsuka Pharmaceutical Development and Commercialization
800 562-3974

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2009

First Posted

October 27, 2009

Study Start

April 1, 2006

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

September 27, 2013

Results First Posted

September 27, 2013

Record last verified: 2013-07

Locations

SE(2)IN(4)CR(1)RU(4)UA(2)AR(2)