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Aripiprazole Open-Label Rollover Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01001702
First received: October 22, 2009
Last updated: October 31, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Schizophrenia
 Drug: Aripiprazole
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open- Label Rollover Study for Subjects With Schizophrenia Completing ABILIFY®(Aripiprazole) Clinical Study 31-03-241

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • Frequency and severity of adverse events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Severity of serious adverse events (including adverse events related to laboratory abnormalities) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Rates of discontinuation from study due to adverse events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean change from baseline of vital signs parameters and laboratory tests [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 85
Study Start Date: April 2006
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aripiprazole
flexible dose between 5 mg and 30 mg Aripiprazole
 Drug: Aripiprazole
flexible dose between 5 mg and 30 mg Aripiprazole

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a confirmed Axis I (DSM-IV) diagnosis of schizophrenia who must have completed Otsuka study 31-03-241 (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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001702

Locations
Argentina
Study site
Buenos Aires, Argentina
Study site
Mendoza, Argentina
Croatia
Study site
Split, Croatia
India
Study site
Hyderabad, India
Study site
Ludhiana, India
Study site
Mumbai, India
Study site
Tamilnadu, India
Russian Federation
Study site
Moscow, Russian Federation
Study site
Rostov-on-Don, Russian Federation
Study site
St.Petersburg, Russian Federation
Study site
Yaroslavl, Russian Federation
Serbia
Study site
Belgrade, Serbia
Study site
Novi Sad, Serbia
Ukraine
Study site
Kharkiv, Ukraine
Study site
Kiev, Ukraine
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01001702     History of Changes
Other Study ID Numbers: 31-05-243
Study First Received: October 22, 2009
Last Updated: October 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Open Label
Aripiprazole

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 23, 2013