Status:
COMPLETED
Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
13-17 years
Phase:
PHASE3
Brief Summary
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 treatm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT01149655
Start Date
July 1 2011
End Date
December 1 2013
Last Update
April 2 2015
Active Locations (52)
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1
Study Site
Downy, California, United States, 90241
2
Study Site
Glendale, California, United States, 91204
3
Study Site
Miami, Florida, United States, 33155
4
Study Site
Miami Springs, Florida, United States, 33166