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

Back to results

Primary Purpose

Status

Terminated

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Aripiprazole

Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Mean Change From Baseline for Fasting Glucose Levels Through Week 16

Mean Change From Baseline in Body Weight Through Week 16

Median Change From Baseline in Body Mass Index (BMI) Through Week 16

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.

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.

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.

Full Information

NCT ID

NCT00508157

First Posted

July 26, 2007

Last Updated

November 20, 2013

Sponsor

Bristol-Myers Squibb

Collaborators

Otsuka America Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT00508157

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Terminated

Why Stopped

Slow Accrual

Study Start Date

November 2007 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

Otsuka America Pharmaceutical

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome, Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

125 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A

Arm Type

Experimental

Arm Title

B

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Aripiprazole

Other Intervention Name(s)

Abilify, BMS-337039

Intervention Description

Tablets, Oral, 5 to 30 mg, once daily, 16 weeks

Intervention Type

Drug

Intervention Name(s)

Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)

Intervention Description

Tablets, Oral, According to summary of product characteristics (SmPC)

Primary Outcome Measure Information:

Title

Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16

Description

Non-HDL cholesterol was calculated as fasting Total Cholesterol minus fasting HDL Cholesterol.

Time Frame

Baseline, Week 16

Secondary Outcome Measure Information:

Title

Number of Participants Remaining on Metabolic Syndrome at Week 16

Description

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.

Time Frame

Week 16

Title

Mean Percent Change From Baseline in Fasting Lipid Parameters Through Week 16

Description

Mean percent change from baseline in total cholesterol, low-density lipoprotein (LDL), HDL, and triglycerides.

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 16

Title

Mean Change From Baseline for Fasting Glucose Levels Through Week 16

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 16

Title

Mean Change From Baseline in Body Weight Through Week 16

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 16

Title

Median Change From Baseline in Body Mass Index (BMI) Through Week 16

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 16

Title

Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Through Week 16

Description

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.

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 16

Title

Mean Change From Baseline in Subjective Well-Being Under Neuroleptics Scale (SWN-short Form) Through Week 16

Description

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.

Time Frame

Baseline, Week 4, Week 8,Week 12, Week 16

Title

Mean Change From Baseline in the Impact of Weight on Quality of Life (IWQoL-Lite) Scale Through Week 16

Description

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.

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution

City

Brussels

ZIP/Postal Code

1160

Country

Belgium

Facility Name

Local Institution

City

Brno

ZIP/Postal Code

602 00

Country

Czech Republic

Facility Name

Local Institution

City

Brno

ZIP/Postal Code

625 00

Country

Czech Republic

Facility Name

Local Institution

City

Havirov

ZIP/Postal Code

736 01

Country

Czech Republic

Facility Name

Local Institution

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czech Republic

Facility Name

Local Institution

City

Prague

ZIP/Postal Code

190 00

Country

Czech Republic

Facility Name

Local Institution

City

Praha 10

ZIP/Postal Code

100 00

Country

Czech Republic

Facility Name

Local Institution

City

Praha 6

ZIP/Postal Code

160 00

Country

Czech Republic

Facility Name

Local Institution

City

Prerov

ZIP/Postal Code

750 02

Country

Czech Republic

Facility Name

Local Institution

City

Roudnice Nad Labem

ZIP/Postal Code

41301

Country

Czech Republic

Facility Name

Local Institution

City

Fains Veel

ZIP/Postal Code

55000

Country

France

Facility Name

Local Institution

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Local Institution

City

Limoges Cedex

ZIP/Postal Code

87025

Country

France

Facility Name

Local Institution

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Local Institution

City

Paris Cedex 14

ZIP/Postal Code

75674

Country

France

Facility Name

Local Institution

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

Local Institution

City

Poitiers

ZIP/Postal Code

86000

Country

France

Facility Name

Local Institution

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Facility Name

Local Institution

City

Ellwangen

ZIP/Postal Code

73479

Country

Germany

Facility Name

Local Institution

City

Werneck

ZIP/Postal Code

97440

Country

Germany

Facility Name

Local Institution

City

Chania-Crete

ZIP/Postal Code

73300

Country

Greece

Facility Name

Local Institution

City

Corfu

ZIP/Postal Code

49100

Country

Greece

Facility Name

Local Institution

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Facility Name

Local Institution

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Local Institution

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33011

Country

Spain

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Local Institution

City

Wetzikon

ZIP/Postal Code

8620

Country

Switzerland

Facility Name

Local Institution

City

Izmir

ZIP/Postal Code

35370

Country

Turkey

Metabolic Syndrome, Schizophrenia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial