Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials

Aripiprazole (BMS-337039) for Outpatients With Schizophrenia Completing Aripiprazole Clinical Trials: A Non-Comparative Rollover Protocol

The purpose of this study is to provide aripiprazole to schizophrenic outpatients and Community Treated Patients who are currently receiving aripiprazole therapy on another BMS sponsored clinical trial.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Aripiprazole

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada
      • Local Institution
  • Quebec
    • Sherbrooke, Quebec, Canada
      • Local Institution
• Croatia
  • Rijeka, Croatia
    • Local Institution
  • Zagreb, Croatia
    • Local Institution
• Czech Republic
  • Hradec Kralove, Czech Republic
    • Local Institution
  • Prague 6, Czech Republic
    • Local Institution
• France
  • Nantes Orvault, France
    • Local Institution
  • Rennes Cedex, France
    • Local Institution
  • Uzes, France
    • Local Institution
• Hungary
  • Budapest, Hungary
    • Local Institution
  • Gyor, Hungary
    • Local Institution
• Netherlands
  • Vught, Netherlands
    • Local Institution
• Poland
  • Krakow, Poland
    • Local Institution
  • Poznan, Poland
    • Local Institution
• Romania
  • Bucharest, Romania
    • Local Institution
• Russian Federation
  • St. Petersburg, Russian Federation
    • Local Institution
• South Africa
  • Free State
    • Westdene, Free State, South Africa
      • Local Institution
  • Gauteng
    • Johannesburg, Gauteng, South Africa
      • Local Institution
  • Western Cape
    • Cape Town, Western Cape, South Africa
      • Local Institution
• United Kingdom
  • Antrim, United Kingdom
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Currently receiving aripiprazole at time of screening
• Men and women ages 18 to 70

Exclusion Criteria:

• All patients previously discontinued from an aripiprazole study for any reason
• Active alcohol or substance abuse
• Patients who represent a significant risk of committing suicide
• Patients with clinically significant abnormal laboratory test results, vital signs or ECG findings

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI	Drug: Aripiprazole; Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country; Other Names: Abilify; BMS-337039

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population.	Baseline is Day 1 of the study, prior to first dose. CGI-S is a questionnaire completed by the clinician which evaluates the severity of mental illness of a participant at a specific point in time. It consists of 7 categories with the lower categories indicating less illness and the higher numbered categories indicating greater severity of illness: 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.	Baseline to Week 348

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population	AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.	Baseline to Week 348
Mean Exposure to Aripiprazole at Days 541 to 630, Days 721 to 810 and Days 1081 to 1170 - Safety Population	Mean exposure is mean number of milligrams per day (mg/day) of aripiprazole administered to the participants.	Day 1 to Day 1170
Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population	Clinically relevant abnormalities: greater than, equal to (>=); less than, equal to (<=). Upper limits of normal (ULN). milligram per deciliter (mg/dL); milliequivalent per liter (mEq/L); nanograms per milliliter (ng/mL);outside of normal range inclusive (): alanine transaminase (ALT>= 3*ULN; aspartate aminotransferase (AST >=3*ULN; alkaline phosphatase >=3*ULN; total bilirubin >= 2.0 mg/dL; blood urea nitrogen >= 30mg/dL; calcium (8.40 - 9.90 mg/dL); chloride (85.00 - 108.00 mEq/L); total cholesterol (140.0 - 200.0 mg/dL); cholesterol high density (HDL) and low density (LDL) lipoprotein (39.0 - 116.0 mg/dL); creatine kinase (15.0 - 170.0 U/L); creatinine >=2.0 mg/dL; prolactin (3.00 - 29.00 ng/mL); sodium (136.0 - 144.0 mEq/L); Glucose fasting (70.0 - 110.0 mg/dL); triglycerides (58.0 - 164.0 mg/dL; uric acid male >= 10.5, female >= 8.5mg/dL. Baseline is Day 1 of the study, prior to study drug administration.	Baseline to end of study (Week 348)
Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population	Clinically relevant laboratory abnormality: Hemoglobin male <= 11.5 g/dL; female <= 9.5 g/dL. Hematocrit male <= 37 and 3 point decrease from baseline (BL); female <=32 and 3 point decrease from BL. Leukocytes <= 2800 mm^3 or >= 16000 mm^3; eosinophils >=10%. Baseline is Day 1 of the study, prior to study drug administration.	Baseline to end of study (Week 348)
Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population	Vital signs include standing, sitting and supine systolic and diastolic blood pressure, measured in millimeters of mercury (mmHg) and standing, sitting and supine heart rate, measured in beats per minute. Baseline (BL) is Day 1 of the study, prior to study drug administration. Criteria for identifying vital sign values as clinically relevant: Systolic blood pressure (criterion value=90-180 mmHg) change relative to baseline: increase of greater than, equal to (>=) 20; decrease of >= 20 mmHg. Diastolic blood pressure (criterion value=50 - 105 mmHg) change relative to baseline: increase of >= 15; decrease of >= 15 mmHg. Heart rate (criterion value=50-120bpm) change relative to baseline: increase >=15; decreased >= 15 mmHg. To be clinically significantly abnormal: value must meet the criterion value and also represent a change from the participant's pre-treatment value of at least the magnitude shown in the change relative to baseline.	Baseline to end of study (Week 348)
Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population	Potentially clinically relevant abnormality or change relative to baseline: sinus tachycardia: >= 120 beats per minute (bpm) and increased >= 15 bpm; sinus bradycardia: <= 50 bpm and decrease >= 15 bpm; supraventricular tachycardia, ventricular tachycardia, atrial fibrillation, atrial flutter: not present to present. First degree atrioventricular (A-V) block: PR interval(beginner of P wave to beginning of complex of Q, R, and S waves) >= 0.20 seconds (sec) and increase >= 0.05 sec; second and third degree A-V block, right bundle branch block (RBB) block, left bundle branch block (LBB) block: not present to present; other intraventricular block: QRS (complex of Q, R and S waves) >= 0.12 sec and increase >= 0.02 sec. Myocardial ischemia not present to present. QT interval with Bazett's correction (QTcB) or Fridericia's correction (QTcF) >= 450 milliseconds (msec) and elevation of 10% over baseline.	Baseline to end of study (Week 348

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborators: Otsuka America Pharmaceutical

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: October 13, 2005
• First Submitted That Met QC Criteria: October 13, 2005
• First Posted (Estimate): October 17, 2005

Study Record Updates

• Last Update Posted (Estimate): December 19, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: CN138-112