Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia (ATTAIN 266)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01149655
First received: June 22, 2010
Last updated: March 3, 2014
Last verified: March 2014

June 22, 2010
March 3, 2014
July 2011
November 2013   (final data collection date for primary outcome measure)
Time from randomization to exacerbation of psychotic symptoms/impending relapse in Phase 3 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01149655 on ClinicalTrials.gov Archive Site
Percentage of subjects meeting exacerbation of psychotic symptoms/impending relapse criteria [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia
A Long-Term Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aripiprazole (OPC 14597) as Maintenance Treatment in Adolescent Patients With Schizophrenia

This will be a randomized, double-blind, placebo-controlled study consisting of a screening period, a conversion phase (Phase 1), a stabilization phase (Phase 2), and a double-blind maintenance treatment phase (Phase 3), and a follow up period.

Subjects may be either outpatients or inpatients between screening and through the time they reach stabilization at the end of Phase 2; hospitalization is not a study requirement. However, eligible subjects must be outpatients at the beginning of Phase 3.

Subjects will be assessed weekly during Phase 1, weekly for the first 4 weeks of Phase 2 and 3, and biweekly for the remaining weeks during each of Phases 2 and 3. Subjects will be encouraged to call the investigators with any exacerbation of psychotic symptoms and/or any tolerability issues. The investigator will also have the option to phone the subjects and their guardian(s) at any time to ensure clinical stability.

A data monitoring committee (DMC) will provide oversight for safety monitoring and reviewing the interim analysis. One interim analysis is planned after 75% of the total expected number of impending relapse events (28 events) are achieved and will be conducted by an independent data analysis center. The DMC will make a recommendation about stopping or continuing the study based on safety and efficacy reviews. The results of the interim analysis and individual subject data will remain blinded to the sponsor during the course of the study until the DMC determines that the study will conclude based on the results of the interim analysis, or the study is completed after 37 endpoint events.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Aripiprazole
    Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
  • Drug: Aripiprazole
    Aripiprazole (10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
  • Experimental: Phase 1
    Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
    Intervention: Drug: Aripiprazole
  • Experimental: Phase 2
    Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
    Intervention: Drug: Aripiprazole
  • Placebo Comparator: Phase 3
    Aripiprazole (10-mg, 15-mg, 20-mg, 25-mg or 30-mg) or placebo
    Intervention: Drug: Aripiprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
252
December 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with a current DSM-IV-TR diagnosis of schizophrenia, and a history of the illness (diagnosis or symptoms) for at least 6 months prior to screening.
  • Subjects who have shown previous response to antipsychotic treatment (other than clozapine) and are not resistant to treatment with other antipsychotics.
  • Subjects who are currently being treated with oral or depot antipsychotics other than clozapine.
  • Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.

Exclusion Criteria:

  • Subjects with a current DSM-IV-TR diagnosis other than schizophrenia.
  • Subjects with delirium, dementia, amnesia or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (i.e., medication, illicit drug use, etc.).
  • Subjects with attention deficit disorder or attention deficit hyperactivity disorder and/or subjects who were on a stimulant treatment for any period of time over the last one year prior to screening.
  • Subjects with any neurodevelopmental disorder, except Tourette's syndrome.
  • Subjects experiencing acute depressive symptoms within the past 30 days prior to screening.
  • Subjects who meet the DSM-IV-TR criteria for substance dependence (including alcohol and benzodiazepines, but excluding caffeine and nicotine) within the past 180 days prior to screening.
  • Subjects who have epilepsy, a history of seizures (except for a single childhood febrile seizure or post-traumatic seizure), or a history of severe head trauma or stroke, or have a history or current evidence of other unstable medical conditions.
  • Subjects with a history of subclinical hypothyroidism (TSH ≥ 4.0 mIU/L), known hypothyroidism or hyperthyroidism (unless the condition has been stabilized with medication for at least 90 days prior to entry into Phase 1 or Phase 2).
  • Subjects who have a medical history of uncontrolled diabetes, labile or unstable diabetes (brittle diabetes), newly diagnosed diabetes, or clinically significant abnormal blood glucose levels.
Both
13 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Romania,   United States,   India,   Malaysia,   Philippines,   Taiwan,   Russian Federation
 
NCT01149655
31-09-266
Yes
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Not Provided
Study Director: Eva Kohegyi, MD Otsuka Pharmaceutical Development and Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP