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

NCT00508157 | Terminated Phase 4 Results

• 2 other identifiers: CN138-489Eudract Number: 2007 001217 42
• Study Type: interventional
• Target: 125
• Locations: 9 countries
• Sites: 30

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.

Conditions

Metabolic Syndrome; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Number of Participants Remaining on Metabolic Syndrome at Week 16

  Week 16

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

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

• Mean Change From Baseline for Fasting Glucose Levels Through Week 16

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

• Mean Change From Baseline in Body Weight Through Week 16

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

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

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

Study Arms (2)

A

EXPERIMENTAL

Drug: Aripiprazole

B

ACTIVE COMPARATOR

Drug: Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)

Interventions

Aripiprazole DRUG

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

Also known as: Abilify, BMS-337039

A

Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine) DRUG

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

B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Otsuka America Pharmaceutical: collaborator

Study Sites (30)

Local Institution

Brussels, 1160, Belgium

Location

Local Institution

Brno, 602 00, Czechia

Location

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Brno, 625 00, Czechia

Location

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Havířov, 736 01, Czechia

Location

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Hradec Králové, 500 05, Czechia

Location

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Prague, 100 00, Czechia

Location

Local Institution

Prague, 160 00, Czechia

Location

Local Institution

Prague, 190 00, Czechia

Location

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Přerov, 750 02, Czechia

Location

Local Institution

Roudnice nad Labem, 41301, Czechia

Location

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Fains-Véel, 55000, France

Location

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Lille, 59037, France

Location

Local Institution

Limoges, 87025, France

Location

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Montpellier, 34295, France

Location

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Paris, 75013, France

Location

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Paris, 75674, France

Location

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Poitiers, 86000, France

Location

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Strasbourg, 67000, France

Location

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Ellwangen, 73479, Germany

Location

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Werneck, 97440, Germany

Location

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Chania-Crete, 73300, Greece

Location

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Corfu, 49100, Greece

Location

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Budapest, 1125, Hungary

Location

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Gyula, 5700, Hungary

Location

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Oviedo, Principality of Asturias, 33011, Spain

Location

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Barcelona, 08025, Spain

Location

Local Institution

Barcelona, 08036, Spain

Location

Local Institution

Barcelona, 08907, Spain

Location

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Wetzikon, 8620, Switzerland

Location

Local Institution

Izmir, 35370, Turkey (Türkiye)

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Metabolic Syndrome; Schizophrenia

Interventions

Aripiprazole; Risperidone; Quetiapine Fumarate; Olanzapine

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrimidinones; Pyrimidines; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Benzodiazepines; Benzazepines

Limitations and Caveats

Following a review of all studies in development, a strategic decision was made to terminate this study due to slow accrual. Patients randomized and treated at the time of study termination could continue the study as per protocol until completion.

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 27, 2007
• Study Start: November 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 13, 2013
• Results First Posted: July 20, 2010

Record last verified: 2013-11

Locations

CH (1); FR (8); ES (4); BE (1); CZ (9); DE (2); GR (2); HU (2); TU (1)