Clinical trial NCT01001702: Oral Aripiprazole Open-Label Rollover Study
Official title: An Open- Label Rollover Study for Subjects With Schizophrenia Completing ABILIFY® (Aripiprazole) Clinical Study 31-03-241
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Open Label
Aripiprazole
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-27
Enrollment: 85
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths
timeFrame: Up to 72 months
Secondary outcomes:
measure: Change From Baseline in Clinical Global Impression Severity of Illness (CGI-S) Score
timeFrame: Baseline, Last Visit (Up to 72 Months)
measure: Number of Participants With Clinical Significant Laboratory Tests
timeFrame: Baseline, Up to 72 Months
measure: Number of Participants With Clinically Significant Heart Rate
timeFrame: Baseline, Up to 72 months
measure: Number of Participants With Clinically Significant Blood Pressure
timeFrame: Baseline, Up to 72 months
measure: Number of Participants With Clinically Abnormal Changes in Electrocardiograms (ECGs) Evaluations
timeFrame: Baseline, Up to 72 months
measure: Number of Participants Showing Significant Weight Gain or Loss
timeFrame: Baseline, Up to 72 months
measure: Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline, Up to 72 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Study site
city: Mendoza
country: Argentina
facility: Study site
city: Split
country: Croatia
facility: Study site
city: Hyderabad
country: India
facility: Study site
city: Ludhiana
country: India
facility: Study site
city: Mumbai
country: India
facility: Study site
city: Tamilnadu
country: India
facility: Study site
city: Moscow
country: Russian Federation
facility: Study site
city: Rostov-on-Don
country: Russian Federation
facility: Study site
city: St.Petersburg
country: Russian Federation
facility: Study site
city: Yaroslavl
country: Russian Federation
facility: Study site
city: Belgrade
country: Serbia
facility: Study site
city: Novi Sad
country: Serbia
facility: Study site
city: Kharkiv
country: Ukraine
facility: Study site
city: Kiev
country: Ukraine
facility: Study site
Study officials:
References: