A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome

Schizophrenia Clinical Trial

Official title:

A 16-Week, Multicenter, Randomized, Open-label Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00508157
• Other study ID #: CN138-489
• Secondary ID: Eudract Number:
• Status: Terminated
• Phase: Phase 4
• First received: July 26, 2007
• Last updated: November 20, 2013
• Start date: November 2007
• Est. completion date: March 2009

Study information

• Verified date: November 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentBelgium: Federal Agency for Medicines and Health Products, FAMHPBelgium: Department Research and Development
• Study type: Interventional

Clinical Trial Summary

258 patients who have been treated for at least 3 months with oral olanzapine, risperidone or quetiapine in the treatment of schizophrenia and currently presenting with metabolic syndrome, will be randomized to: i) aripiprazole for 16 weeks, with flexible dosing within a range of 10 to 30 mg once daily (QD); or ii) continue for 16 weeks on the same atypical antipsychotic treatment prior to the study enrollment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 125
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Patients:

• with schizophrenia being treated with olanzapine, risperidone, or quetiapine for at least 3 months

• with diagnosis of metabolic syndrome

• not treated for 1 of the parameters of metabolic syndrome

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Schizophrenia
• Syndrome

Intervention

Drug:
• Aripiprazole
Tablets, Oral, 5 to 30 mg, once daily, 16 weeks
• Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)
Tablets, Oral, According to summary of product characteristics (SmPC)

Locations

Country	Name	City	State
Belgium	Local Institution	Brussels
Czech Republic	Local Institution	Brno
Czech Republic	Local Institution	Brno
Czech Republic	Local Institution	Havirov
Czech Republic	Local Institution	Hradec Kralove
Czech Republic	Local Institution	Prague
Czech Republic	Local Institution	Praha 10
Czech Republic	Local Institution	Praha 6
Czech Republic	Local Institution	Prerov
Czech Republic	Local Institution	Roudnice Nad Labem
France	Local Institution	Fains Veel
France	Local Institution	Lille Cedex
France	Local Institution	Limoges Cedex
France	Local Institution	Montpellier
France	Local Institution	Paris
France	Local Institution	Paris Cedex 14
France	Local Institution	Poitiers
France	Local Institution	Strasbourg
Germany	Local Institution	Ellwangen
Germany	Local Institution	Werneck
Greece	Local Institution	Chania-Crete
Greece	Local Institution	Corfu
Hungary	Local Institution	Budapest
Hungary	Local Institution	Gyula
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Oviedo	Asturias
Switzerland	Local Institution	Wetzikon
Turkey	Local Institution	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Otsuka America Pharmaceutical

Countries where clinical trial is conducted

Belgium,  Czech Republic,  France,  Germany,  Greece,  Hungary,  Spain,  Switzerland,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16	Non-HDL cholesterol was calculated as fasting Total Cholesterol minus fasting HDL Cholesterol.	Baseline, Week 16	Yes
Secondary	Number of Participants Remaining on Metabolic Syndrome at Week 16	Metabolic syndrome is defined as the presence of at least 3 out of the following Adult Treatment Panel III-A (ATP III-A) criteria (all of which are to be assessed at the same visit): waist >102 cm in males, >88 cm in females; blood pressure (BP) systolic BP =130 or diastolic BP =85 mm Hg; fasting HDL <40 mg/dL in males, <50 mg/dL in females; fasting triglycerides =150 mg/dL; fasting glucose =100 mg/dL, and/or the start of a treatment for any of the parameters of metabolic syndrome during the course of the study.	Week 16	Yes
Secondary	Mean Percent Change From Baseline in Fasting Lipid Parameters Through Week 16	Mean percent change from baseline in total cholesterol, low-density lipoprotein (LDL), HDL, and triglycerides.	Baseline, Week 4, Week 8, Week 12, Week 16	Yes
Secondary	Mean Change From Baseline for Fasting Glucose Levels Through Week 16		Baseline, Week 4, Week 8, Week 12, Week 16	Yes
Secondary	Mean Change From Baseline in Body Weight Through Week 16		Baseline, Week 4, Week 8, Week 12, Week 16	Yes
Secondary	Median Change From Baseline in Body Mass Index (BMI) Through Week 16		Baseline, Week 4, Week 8, Week 12, Week 16	Yes
Secondary	Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Through Week 16	A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=normal; 7=among the most extremely ill patients). A decrease in value indicates improvement.	Baseline, Week 4, Week 8, Week 12, Week 16	No
Secondary	Mean Change From Baseline in Subjective Well-Being Under Neuroleptics Scale (SWN-short Form) Through Week 16	The SWN-short form is a 20-item self-report instrument that measures subjective well-being under neuroleptics. 10 positive and 10 negative items cover 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). With negative item scores being reversed, Subscale scores range from 4 to 24 and Total score ranges from 20 to 120.	Baseline, Week 4, Week 8,Week 12, Week 16	No
Secondary	Mean Change From Baseline in the Impact of Weight on Quality of Life (IWQoL-Lite) Scale Through Week 16	IWQoL-Lite is a 31-item self-report inventory to assess the impact of weight on quality of life among patients with obesity. Subscales include: Physical Function, Self Esteem, Sexual Life, Public Distress and Work. The rescaled IWQoL-Lite Total Score is determined by the sum of the 1 to 5 scores on all 31 items and rescaling this sum to a 0-100 scoring with 0=the poorest and 100=the best quality of life. A change of 7.8 to 12.0 points on the rescaled IWQoL-Lite Total Score=a meaningful improvement. A change of -4.5 to -7.6 on the rescaled IWQoL-Lite Total Score=a meaningful deterioration.	Baseline, Week 4, Week 8, Week 12, Week 16	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form