Metabolic SyndromePhase 4NCT00508157
A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome
A Phase 4 study testing Aripiprazole and Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine) in people with Metabolic Syndrome and Schizophrenia, run by Bristol-Myers Squibb at 30 sites in 9 countries.
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)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome, Schizophrenia
- What is being tested?
- Aripiprazole and Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 30 sitesin 9 countries
- Study dates
- Nov 2007to Mar 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
30 sites in 9 countries.
30 sites in 9 countries
Czechia9 sites
Local Institution
Brno, 602 00
Local Institution
Brno, 625 00
Local Institution
Havířov, 736 01
Local Institution
Hradec Králové, 500 05
Local Institution
Prague, 100 00
Local Institution
Prague, 160 00
Local Institution
Prague, 190 00
Local Institution
Přerov, 750 02
Local Institution
Roudnice nad Labem, 41301
France8 sites
Local Institution
Fains-Véel, 55000
Local Institution
Lille, 59037
Local Institution
Limoges, 87025
Local Institution
Montpellier, 34295
Local Institution
Paris, 75013
Local Institution
Paris, 75674
Local Institution
Poitiers, 86000
Local Institution
Strasbourg, 67000
Spain4 sites
Local Institution
Barcelona, 08025
Local Institution
Barcelona, 08036
Local Institution
Barcelona, 08907
Local Institution
Oviedo, Principality of Asturias, 33011
Germany2 sites
Local Institution
Ellwangen, 73479
Local Institution
Werneck, 97440
Greece2 sites
Local Institution
Chania-Crete, 73300
Local Institution
Corfu, 49100
About this study
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
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
- Being tested
- Aripiprazole, Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)
- Medical subject headings
- Metabolic Syndrome, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Also called Abilify, BMS-337039
Tablets, Oral, 5 to 30 mg, once daily, 16 weeks
Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)Drug
Tablets, Oral, According to summary of product characteristics (SmPC)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Aripiprazole |
| B | Active comparator | Not described Receives: Drug: Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 16
Secondary outcomes (8)
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.
Measured: Week 16
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.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16
Mean Change From Baseline for Fasting Glucose Levels Through Week 16
Measured: Baseline, Week 4, Week 8, Week 12, Week 16
Mean Change From Baseline in Body Weight Through Week 16
Measured: Baseline, Week 4, Week 8, Week 12, Week 16
Median Change From Baseline in Body Mass Index (BMI) Through Week 16
Measured: Baseline, Week 4, Week 8, Week 12, 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.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16
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.
Measured: Baseline, Week 4, Week 8,Week 12, Week 16
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.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startNov 2007
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508157
- Sponsor's protocol ID
- CN138-489
- Other IDs
- Eudract Number: 2007 001217 42
- Status last verified
- Nov 2013
- First submitted
- 26 Jul 2007
- Last updated
- 13 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00508157
- Acronym / sponsor ID
- CN138-489
- Conditions
- Metabolic Syndrome, Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Study start
- Nov 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 27 Jul 2007 (estimated)
- Results
- Posted 20 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Aripiprazole |
| B | Active comparator | Drug: Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AripiprazoleAlso: Abilify, BMS-337039Tablets, Oral, 5 to 30 mg, once daily, 16 weeks | Drug | A |
| Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)Tablets, Oral, According to summary of product characteristics (SmPC) | Drug | B |
Primary outcome
Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16
Time frame: Baseline, Week 16
Non-HDL cholesterol was calculated as fasting Total Cholesterol minus fasting HDL Cholesterol.
8 secondary outcomes
Number of Participants Remaining on Metabolic Syndrome at Week 16
Time frame: Week 16
Mean Percent Change From Baseline in Fasting Lipid Parameters Through Week 16
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Mean Change From Baseline for Fasting Glucose Levels Through Week 16
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Mean Change From Baseline in Body Weight Through Week 16
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Median Change From Baseline in Body Mass Index (BMI) Through Week 16
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Through Week 16
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Mean Change From Baseline in Subjective Well-Being Under Neuroleptics Scale (SWN-short Form) Through Week 16
Time frame: Baseline, Week 4, Week 8,Week 12, Week 16
Mean Change From Baseline in the Impact of Weight on Quality of Life (IWQoL-Lite) Scale Through Week 16
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
30 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole and Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine) in people with Metabolic Syndrome and Schizophrenia, run by Bristol-Myers Squibb at 30 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Czechia, France, Spain, Germany, Greece and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16 (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2013.