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.

NCT01122927 | Terminated Phase 3 Results

• 1 other identifier: 31-09-267
• Study Type: interventional
• Target: 524
• Locations: 13 countries
• Sites: 101

Brief Summary

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

Conditions

Adolescent Schizophrenia; Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features

Keywords

schizophrenia; adolescent; bipolar

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  An AE was defined as any untoward medical occurrence in a participant or participant enrolled in a clinical trial and which did not necessarily have a causal relationship with the study medication. A treatment emergent adverse event (TEAE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study medication, whether or not considered to have a causal relationship with the study medication. A serious-AE or reaction was any untoward occurrence that, at any dose, was fatal, life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was any other medically significant event that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.

  Adverse events were recorded from the time of the informed consent was signed throughout the 24 month treatment period until the follow-up visit 30 (± 3) days after the end of trial.

Secondary Outcomes (22)

• Incidence of Laboratory Values of Potential Clinical Relevance

  Baseline to Month 24

• Incidence of Physical Examination Findings of Potential Clinical Relevance

  Baseline to Month 24

• Incidence of Vital Signs of Potential Clinical Relevance

  Baseline to Month 24

• Mean Change From Baseline by Week in Abnormal Involuntary Movement Scale (AIMS)

  Baseline to Month 24

• Mean Change From Baseline by Week in Simpson-Angus Scale (SAS) Total Score

  Baseline to Month 24

Study Arms (1)

Phase 1 and Phase 2

EXPERIMENTAL

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

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg) pill taken orally once per day

Phase 1 and Phase 2

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (101)

Study Site

Dothan, Alabama, 36303, United States

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Downey, California, 90241, United States

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Miami, Florida, 33155, United States

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Miami, Florida, 33166, United States

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Atlanta, Georgia, 30308, United States

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Smyrna, Georgia, 30080, United States

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Oak Brook, Illinois, 60523, United States

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Wichita, Kansas, 67214, United States

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Minneapolis, Minnesota, 55454, United States

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Buffalo, New York, 14215, United States

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Stony Brook, New York, 11794, United States

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Chapel Hill, North Carolina, 27517, United States

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Cincinnati, Ohio, 45219, United States

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Cleveland, Ohio, 44106, United States

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Oklahoma City, Oklahoma, 73116, United States

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Philadelphia, Pennsylvania, 19139, United States

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Houston, Texas, 77090, United States

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San Antonio, Texas, 78258, United States

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The Woodlands, Texas, 77381, United States

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Richmond, Virginia, 23230, United States

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Bellevue, Washington, 98004, United States

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Bothell, Washington, 98011, United States

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Milwaukee, Wisconsin, 53227, United States

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Burgas, 8000, Bulgaria

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Pazardzhik, 4400, Bulgaria

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Plovdiv, 4000, Bulgaria

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Rousse, 7004, Bulgaria

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Study Site 2

Sofia, 1431, Bulgaria

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Targovishte, 7700, Bulgaria

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Varna, 9010, Bulgaria

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Varna, 9010, Bulgaria

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Rijeka, 51000, Croatia

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Zagreb, 10000, Croatia

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Zagreb, 10000, Croatia

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Budapest, H-1021, Hungary

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Budapest, H-1135, Hungary

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Gyula, H-5700, Hungary

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Szeged, H-6725, Hungary

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Vijayawada, Andhra Pradesh, 520002, India

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Visakhapatnam, Andhra Pradesh, 530002, India

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Visakhapatnam, Andhra Pradesh, 530017, India

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Ahmedabad, Gujarat, 380006, India

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Study Site 2

Ahmedabad, Gujarat, 380006, India

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Ahmedabad, Gujarat, 380013, India

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Maninagar, Ahmedabad, Gujarat, 380008, India

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Mangalore, Karnataka, 575001, India

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Calicut, Kerala, 673009, India

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Nashik, Maharashtra, 422101, India

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Ludhiana, Punjab, 141001, India

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Jaipur, Rajasthan, 302017, India

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Chennai, Tamil Nadu, 600003, India

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Maduri, Tamil Nadu, 625020, India

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Kanpur, Uttar Pradesh, 208005, India

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Lucknow, Uttar Pradesh, 226003, India

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Varanasi, Uttar Pradesh, 221005, India

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Guntur, 522001, India

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Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

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Dasmariñas, Cavite, 4114, Philippines

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Manila, National Capital Region, 1000, Philippines

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Iloilo City, 5000, Philippines

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Mandaluyong, 1553, Philippines

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Bialystok, 15-879, Poland

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Gdansk Wrzeszcz, 80-282, Poland

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Torun, 87-100, Poland

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Wroclaw, 50-227, Poland

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Wroclaw, 54-235, Poland

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Cluj-Napoca, Cluj, 400084, Romania

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Timișoara, Timiș County, 300239, Romania

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Bucharest, 041914, Romania

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Craiova, Dolj, 200620, Romania

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Iași, 700282, Romania

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Nizhny Novgorod, Russian Federation, 603155, Russia

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Novosibirsk, Russian Federation, 630091, Russia

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Tonnelnyi Township, Russian Federation, 357034, Russia

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Kazan', 420061, Russia

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Lipetsk, 399313, Russia

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Moscow, 124617, Russia

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Moscow, 127083, Russia

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Orenburg Region, 460551, Russia

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Petrozavodsk, 185001, Russia

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Saint Petersburg, 190005, Russia

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Saint Petersburg, 197376, Russia

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Saratov, 410028, Russia

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Tomsk, 634014, Russia

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Yaroslavl, 150003, Russia

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Yekaterinburg, 620030, Russia

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Belgrade, 11000, Serbia

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Belgrade, 11000, Serbia

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Novi Sad, 21000, Serbia

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Taipei, 110, Taiwan

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Dnipro, 49005, Ukraine

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Donetsk, 83037, Ukraine

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Kharkiv, 61068, Ukraine

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Study Site 2

Kharkiv, 61068, Ukraine

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Kherson, 73488, Ukraine

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Luhansk, 91045, Ukraine

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Lviv, 79021, Ukraine

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Odesa, 65006, Ukraine

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Simferopol Crimea, 95006, Ukraine

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Temopil, 4620, Ukraine

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Vinnytsia, 21005, Ukraine

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MeSH Terms

Conditions

Mania; Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

The study was terminated by the Sponsor as the European Medicines Agency P/99/2011Aripiprazole PIP which directed the sponsor to provide 2 years of safety data for at least 100 participants. The objective was met in April 2014.

Results Point of Contact

• Title: Global Medical Affairs
• Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.

800 562-3974

Study Officials

• Eva Kohegyi, MD

  Otsuka Pharmaceutical Development and Commercialization, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 13, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 8, 2016
• Results First Posted: February 8, 2016

Record last verified: 2016-01

Locations

US (23); HU (4); MY (1); RO (5); RU (15); SE (3); TW (1); UA (11); CR (3); IN (18); PH (4); PL (5); BU (8)