Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 13 - 17 |
| Updated: | 11/30/2013 |
| Start Date: | July 2011 |
| End Date: | May 2014 |
| Contact: | Study Information |
| Email: | ATTAINstudyinfo@mmgct.com |
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.
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.
We found this trial at
11
sites
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