The purpose of this study is to test the long-term safety and tolerability of oral aripiprazole in adolescent patients with schizophrenia.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Flexible dose between 5 mg and 30 mg Aripiprazole tablets.
Study site
Buenos Aires, Argentina
Study site
Mendoza, Argentina
Study site
Split, Croatia
Study site
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths
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.
Time frame: Up to 72 months
Change From Baseline in Clinical Global Impression Severity of Illness (CGI-S) Score
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
Time frame: Baseline, Last Visit (Up to 72 Months)
Number of Participants With Clinical Significant Laboratory Tests
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 \[Reference range: 2 to 18 ng/mL (males) and 3 to 30 ng/mL (females)\].
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Hyderabad, India
Study site
Ludhiana, India
Study site
Mumbai, India
Study site
Tamilnadu, India
Study site
Moscow, Russia
Study site
Rostov-on-Don, Russia
Study site
Saint Petersburg, Russia
...and 5 more locations
Time frame: Baseline, Up to 72 Months
Number of Participants With Clinically Significant Heart Rate
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.
Time frame: Baseline, Up to 72 months
Number of Participants With Clinically Significant Blood Pressure
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.
Time frame: Baseline, Up to 72 months
Number of Participants With Clinically Abnormal Changes in Electrocardiograms (ECGs) Evaluations
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.
Time frame: Baseline, Up to 72 months
Number of Participants Showing Significant Weight Gain or Loss
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.
Time frame: Baseline, Up to 72 months
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
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.
Time frame: Baseline, Up to 72 months