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Oral Aripiprazole Open-Label Rollover Study

29 juli 2013 uppdaterad av: Otsuka Pharmaceutical Development & Commercialization, Inc.

An Open- Label Rollover Study for Subjects With Schizophrenia Completing ABILIFY® (Aripiprazole) Clinical Study 31-03-241

The purpose of this study is to test the long-term safety and tolerability of oral aripiprazole in adolescent patients with schizophrenia.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

85

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Argentina
      • Buenos Aires, Argentina
        • Study Site
      • Mendoza, Argentina
        • Study Site
  • Indien
      • Hyderabad, Indien
        • Study Site
      • Ludhiana, Indien
        • Study Site
      • Mumbai, Indien
        • Study Site
      • Tamilnadu, Indien
        • Study Site
  • Kroatien
      • Split, Kroatien
        • Study Site
  • Ryska Federationen
      • Moscow, Ryska Federationen
        • Study Site
      • Rostov-on-Don, Ryska Federationen
        • Study Site
      • St.Petersburg, Ryska Federationen
        • Study Site
      • Yaroslavl, Ryska Federationen
        • Study Site
  • Serbien
      • Belgrade, Serbien
        • Study Site
      • Novi Sad, Serbien
        • Study Site
  • Ukraina
      • Kharkiv, Ukraina
        • Study Site
      • Kiev, Ukraina
        • Study Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

13 år till 18 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Subjects with a confirmed Axis I Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia who must have completed Otsuka study 31-03-241 (NCT00102518) treatment of adolescent subjects with schizophrenia

Exclusion Criteria:

  • Patients with a co-morbid serious, uncontrolled systemic illness
  • Patients with a significant risk of committing suicide

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Oral Aripiprazole
Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Läkemedel: Aripiprazole
Flexible dose between 5 mg and 30 mg Aripiprazole tablets.
Andra namn:
  • ABILIFY®

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths
Tidsram: Up to 72 months

An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject. Change in clinical relevance (severity increased) was entered as a new AE in the current trial. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (clinically significant) change from baseline for that individual subject.

An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention.

Additional information about Adverse Events can be found in the Adverse Event section.
Up to 72 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Clinical Global Impression Severity of Illness (CGI-S) Score
Tidsram: Baseline, Last Visit (Up to 72 Months)

The rater or investigator answered the following question:

"Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Response choices included: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. A negative change from Baseline indicated improvement
Baseline, Last Visit (Up to 72 Months)
Number of Participants With Clinical Significant Laboratory Tests
Tidsram: Baseline, Up to 72 Months

Blood was collected for Fasting clinical laboratory tests (serum chemistry and hematology) at Baseline, Months 12, 24, 36, 48, 60, and 72 and were analyzed at a central laboratory.

Clinically significant values are defined as the following:

Bilirubin, total ≥ 2.0 mg/dL. Creatine phosphokinase > 500 U/L for participants 13-17 years or 3 times the upper limit of normal for participants ≥ 18 years [Reference Range (0 to 190 IU/L (females) and 0 to 235 IU/L (males)].

Eosinophils ≥ 10 %. Hematocrit < 30 % for participants 13-17 years old or ≥ 18 year old participants female ≤ 32 % and a 3 point decrease from baseline or male ≤ 37 % and a 3 point decrease from baseline.

Hemoglobin female ≤ 9.5 g/dL or male ≤ 11.5 g/dL. Prolactin > 1 times the upper limit of normal [Reference range: 2 to 18 ng/mL (males) and 3 to 30 ng/mL (females)].
Baseline, Up to 72 Months
Number of Participants With Clinically Significant Heart Rate
Tidsram: Baseline, Up to 72 months
Heart rate was measured at Baseline and at each visit supine (lying on the back) and standing. A heart rate increase is an increase of ≥ 15 beats per minute (bpm) compared to Baseline. A heart rate decrease is a decrease of ≥ 15 bpm compared to Baseline.
Baseline, Up to 72 months
Number of Participants With Clinically Significant Blood Pressure
Tidsram: Baseline, Up to 72 months

Systolic and Diastolic blood pressure was measured at Baseline and at all visits supine (lying on the back) and standing.

Systolic increase was an increase of ≥ 20 mm Hg compared to Baseline and systolic decrease was a decrease of ≥ 20 mm Hg compared to Baseline.

A diastolic increase was an increase of ≥ 15 mm Hg compared to Baseline and a diastolic decrease was a decrease of ≥ 15 mm Hg compared to Baseline.
Baseline, Up to 72 months
Number of Participants With Clinically Abnormal Changes in Electrocardiograms (ECGs) Evaluations
Tidsram: Baseline, Up to 72 months

A 12-lead ECG was recorded at Baseline, Months 6, 12, 24, 36, 48, 60 and 72. Three readings taken 5 minutes were read by a central ECG reading service and averaged.

Clinically significant ECGs were defined as:

Sinus Bradycardia: ≤ 50 beats per minute (bpm), decrease of ≥ 15 bpm from Baseline.

Supraventricular premature beat: ≥ 2 per 10 seconds, increase from Baseline. Ventricular premature beat: ≥ 1 per 10 seconds, increase from Baseline. Right bundle branch block: present. Other intraventricular block: QRS ≥ 0.10 seconds for age 13-17 years or QRS ≥ 0.11 seconds for age ≥ 18 years, an increase of ≥ 0.02 seconds from Baseline.

Symmetrical T-wave inversion: present. QTcB (QT interval corrected Bazett's formula), QTcF (QT interval corrected Fridericia's formula), QTcN (QT corrected FDA Neuropharmacology Division formula), QTcE (QT corrected fractional exponent correction method: ≥ 420 msec for age 13-17 years or ≥ 450 msec for age ≥ 18 years, ≥ 10 % increase from Baseline.
Baseline, Up to 72 months
Number of Participants Showing Significant Weight Gain or Loss
Tidsram: Baseline, Up to 72 months
Weight was measured at Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72. A clinically significant weight gain was defined as a ≥ 7 % increase from Baseline. A clinically significant Weight loss was defined as a ≥ 7% decrease from Baseline.
Baseline, Up to 72 months
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Tidsram: Baseline, Up to 72 months
The C-SSRS consisted of a baseline evaluation (completed at the first scheduled visit upon approval of protocol Amendment 3) that assessed the lifetime experience of the participant with suicide events and suicidal ideation and a post-baseline evaluation at each visit that focused on suicidality since the last trial visit. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). The number of participants experiencing suicidal ideation or suicidal behavior is reported.
Baseline, Up to 72 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2006

Primärt slutförande (Faktisk)

1 juli 2012

Avslutad studie (Faktisk)

1 juli 2012

Studieregistreringsdatum

Först inskickad

22 oktober 2009

Först inskickad som uppfyllde QC-kriterierna

23 oktober 2009

Första postat (Uppskatta)

27 oktober 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

27 september 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 juli 2013

Senast verifierad

1 juli 2013

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 31-05-243

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