Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia

NCT ID: NCT01149655

Last Updated: 2015-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-12-31

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 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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Phase 1

Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)

Phase 2

Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)

Phase 3

Aripiprazole (10-mg, 15-mg, 20-mg, 25-mg or 30-mg) or placebo

Group Type: PLACEBO_COMPARATOR

Aripiprazole

Intervention Type: DRUG

Aripiprazole (10-mg, 15-mg, 20-mg, 25-mg or 30-mg)

Interventions

Aripiprazole

Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)

Intervention Type: DRUG

Aripiprazole

Aripiprazole (10-mg, 15-mg, 20-mg, 25-mg or 30-mg)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva Kohegyi, MD

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Development and Commercialization, Inc.

Locations

Study Site

Downy, California, United States

Study Site

Glendale, California, United States

Study Site

Miami, Florida, United States

Study Site

Miami Springs, Florida, United States

Study Site

Atlanta, Georgia, United States

Study Site

Bloomfield Hills, Michigan, United States

Study Site

Chapel Hill, North Carolina, United States

Study Site

Bothell, Washington, United States

Study Site

Vijayawada, Andhra Pradesh, India

Study Site

Visakhapatnam, Andhra Pradesh, India

Study Site

Raipur, Chhattisgarh, India

Study Site

Maninagar, Ahmedabad, Gujarat, India

Study Site

Aurangabad, Maharashtra, India

Study Site

Wardha, Maharashtra, India

Study Site

Chennai, Tamil Nadu, India

Study Site

Madurai, Tamil Nadu, India

Study Site

Lucknow, Uttar Pradesh, India

Study Site

Varanasi, Uttar Pradesh, India

Study Site

Guntur, , India

Study Site

Kuala Lumpur, Kuala Lumpur, Malaysia

Study Site

Ipoh, Perak, Malaysia

Study Site

Batu Caves, Selangor, Malaysia

Study Site

Johor Bahru, , Malaysia

Study Site

Dasmariñas, Cavite, Philippines

Study Site

Bajada, Davao City, Philippines

Study Site

Manila, National Capital Region, Philippines

Study Site

Iloilo City, , Philippines

Study Site

Mandaluyong, , Philippines

Study Site

Cluj-Napoca, Cluj, Romania

Study Site

Craiova, Dolj, Romania

Study Site

Timișoara, Timiș County, Romania

Study Site

Bucharest, , Romania

Study Site

Iași, , Romania

Study Site

Arkhangelsk, , Russia

Study Site

Kazan', , Russia

Study Site

Lipetsk, , Russia

Study Site

Moscow, , Russia

Study Site

Moscow, , Russia

Study Site

Nizhny Novgorod, , Russia

Study Site

Novosibirsk, , Russia

Study Site

Orenburg, , Russia

Study Site

Petrozavodsk, , Russia

Study Site

Saint Petersburg, , Russia

Study Site

Saint Petersburg, , Russia

Study Site

Saratov, , Russia

Study Site

Tomsk, , Russia

Study Site

Tonnelnyi Township, , Russia

Study Site

Yaroslavl, , Russia

Study Site

Yekaterinburg, , Russia

Study Site

Kaohsiung County, , Taiwan

Study Site

Taipei, , Taiwan

Study Site

Taoyuan, , Taiwan

Countries

United States; India; Malaysia; Philippines; Romania; Russia; Taiwan

References

Correll CU, Kohegyi E, Zhao C, Baker RA, McQuade R, Salzman PM, Sanchez R, Nyilas M, Carson W. Oral Aripiprazole as Maintenance Treatment in Adolescent Schizophrenia: Results From a 52-Week, Randomized, Placebo-Controlled Withdrawal Study. J Am Acad Child Adolesc Psychiatry. 2017 Sep;56(9):784-792. doi: 10.1016/j.jaac.2017.06.013. Epub 2017 Jul 8.

Reference Type: DERIVED

PMID: 28838583 (View on PubMed)

Other Identifiers

31-09-266

Identifier Type: -

Identifier Source: org_study_id