Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features. (ATTAIN 267)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01122927
First received: May 6, 2010
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

This is an open-label study consisting of a screening period, a conversion/titration phase (Phase 1), an open-label treatment phase (Phase 2), and a follow-up period.

The study will enroll new subjects (hereafter referred as "de novo" subjects) with schizophrenia, or bipolar I disorder, manic or mixed episode with or without psychotic features, and rollover subjects with schizophrenia from 31-09-266 (hereafter referred to as "Study 266"). All de novo subjects must enter the screening period of the study. Subjects who are screened and are not required to go through Phase 1 will complete a Phase 2 baseline visit prior to their participation in Phase 2.

Study Design: Treatment, Single Group Assignment, Open Label, Active Control, Safety/Efficacy Study


Condition Intervention Phase
Adolescent Schizophrenia
Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
Drug: Aripiprazole
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-term, Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Flexible-Dose Oral Aripiprazole (OPC-14597) as Maintenance Treatment in Adolescent Patients With Schizophrenia or Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Adverse events and severe adverse events [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    The frequency and severity of AEs, SAEs (clinical and laboratory), and discontinuation from study due to AEs


Secondary Outcome Measures:
  • Lab and Urinalysis [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]

    Mean change from baseline and incidence of clinically significant abnormalities in clinical laboratory tests and urinalysis results (including fasting blood lipids, glucose and insulin, serum prolactin, hemoglobin A1C [HbA1c] and creatinine phosphokinase [CPK]), vital signs (supine and standing positions) and ECG parameters.

    Review of physical examination findings

    • Mean change from baseline of z-scores for height and body weight, mean changes of BMI and waist circumference
    • Mean change from baseline on the AIMS, SAS, and BARS
    • The frequency of symptom items for the clinician-administered New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment: (NY-AACENT).
    • Baseline and postbaseline Tanner Staging
    • Analysis of potential suicide events recorded on the C-SSRS
    • Time to discontinuation due to AE


Enrollment: 651
Study Start Date: July 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 1 and Phase 2
Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
Drug: Aripiprazole
Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg) pill taken orally once per day

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects 13-17 years old (Schizophrenia); Subjects 10-17 years old (Bipolar manic or mixed episode)* [*Bulgaria will enroll Schizophrenia subjects only.]
  • Subjects with a current diagnosis of schizophrenia, and a history of the illness (diagnosis or symptoms) for at least 6 months prior to screening (as per subject, family, or healthcare provider, or by previous medical records).
  • Subjects with a current diagnosis of bipolar I disorder, manic or mixed episode with or without psychotic features (diagnosis or symptoms) experiencing symptoms for at least 1 week prior to screening. * [*These subjects will not be eligible to enroll in Bulgaria]
  • 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 antipsychotics other than clozapine, and are not resistant to treatment with other antipsychotics.
  • Inpatient or outpatient status, with the exception of acute hospitalization due to psychiatric reasons at the time of screening or before Phase 2.

Exclusion Criteria:

  • All subjects: diagnosis of schizoaffective disorder, autism, pervasive developmental disorder (PDD), OCD, or PTSD.
  • Subjects with schizophrenia: a current major depressive episode.
  • Subjects with bipolar manic or mixed episode: presenting with a clinical picture and/or history that is consistent with a diagnosis of bipolar II disorder or bipolar disorder not otherwise specified.
  • 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 any neurological disorder, with the exception of Tourette's syndrome.
  • Subjects experiencing major depressive episode at the time of screening other than subjects diagnosed with bipolar I disorder mixed episode.
  • Subjects who are currently receiving clozapine or have received clozapine at any time in the past are ineligible for entry into the study.
  • 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 medications 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 (defined as fasting blood glucose ≥ 125 mg/dL).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01122927

  Show 99 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
Study Director: Eva Kohegyi, MD Otsuka Pharmaceutical Development and Commercialization, Inc.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01122927     History of Changes
Other Study ID Numbers: 31-09-267
Study First Received: May 6, 2010
Last Updated: June 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
schizophrenia
adolescent
bipolar

Additional relevant MeSH terms:
Bipolar Disorder
Mental Disorders
Psychotic Disorders
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
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 July 22, 2014