Oral Aripiprazole Open-Label Rollover Study

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001702
• Other study ID #: 31-05-243
• Status: Completed
• Phase: Phase 3
• First received: October 22, 2009
• Last updated: July 29, 2013
• Start date: April 2006
• Est. completion date: July 2012

Study information

• Verified date: July 2013
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Aripiprazole
Flexible dose between 5 mg and 30 mg Aripiprazole tablets.

Locations

Country	Name	City	State
Argentina	Study site	Buenos Aires
Argentina	Study site	Mendoza
Croatia	Study site	Split
India	Study site	Hyderabad
India	Study site	Ludhiana
India	Study site	Mumbai
India	Study site	Tamilnadu
Russian Federation	Study site	Moscow
Russian Federation	Study site	Rostov-on-Don
Russian Federation	Study site	St.Petersburg
Russian Federation	Study site	Yaroslavl
Serbia	Study site	Belgrade
Serbia	Study site	Novi Sad
Ukraine	Study site	Kharkiv
Ukraine	Study site	Kiev

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Countries where clinical trial is conducted

Argentina,  Croatia,  India,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 72 months	No
Secondary	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	Baseline, Last Visit (Up to 72 Months)	No
Secondary	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)].	Baseline, Up to 72 Months	No
Secondary	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.	Baseline, Up to 72 months	No
Secondary	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.	Baseline, Up to 72 months	No
Secondary	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.	Baseline, Up to 72 months	No
Secondary	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.	Baseline, Up to 72 months	No
Secondary	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.	Baseline, Up to 72 months	No