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.



Status:Terminated
Conditions:Schizophrenia, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:10 - 17
Updated:4/21/2016
Start Date:July 2010
End Date:September 2014

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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

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


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).
We found this trial at
23
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