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SchizophreniaPhase 3NCT00857818

Trial Comparing the Effects of Aripiprazole With Those of Standard of Care on Non-HDL Cholesterol in Patients With Schizophrenia or Bipolar I Disorder Who Have Metabolic Syndrome

A Phase 3 study testing Aripiprazole and Oanzapine, risperidone, or quetiapine in people with Schizophrenia and Schizoaffective Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 14 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study was to determine whether patients with schizophrenia, schizoaffective disorder, or bipolar I disorder who also have metabolic syndrome have a larger decrease in fasting non-high density lipoprotein (non-HDL) cholesterol levels with aripiprazole than with their current atypical antipsychotic… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Aripiprazole and Oanzapine, risperidone, or quetiapine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
14 sitesCanada
Study dates
Apr 2009to Mar 2010
Phase
Phase 3
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

  • Competency in understanding nature of study and ability to sign informed consent form
  • A clinical diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder (manic or mixed) that has been treated with antipsychotics (oral olanzapine, risperidone or quetiapine) for at least 3 months.
  • Treatment with any of the antipsychotic medications olanzapine, risperidone, or quetiapine for at least 3 months
  • A Clinical Global Impression-Severity Scale score of 4 or lower at baseline
  • Confirmed diagnosis of metabolic syndrome
  • Patients not receiving treatment specifically for any of the parameters related to metabolic syndrome at the time of randomization
  • Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and up to 4 weeks after last dose of investigational product
  • Patients for whom it is clinically appropriate to switch from their current atypical antipsychotic to aripiprazole (determined by the investigator)

Who cannot join

  • Risk of suicide (suicidal ideation or recently attempted suicide)
  • Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revision criteria for any significant psychoactive substance use disorder within 3 months of screening
  • Diagnosis of type 1 or 2 diabetes mellitus
  • Current treatment for 1 of the components of metabolic syndrome
  • Use of medication for the purpose of weight loss
  • Diagnosis of bipolar disorders other than bipolar 1, depression with psychotic symptoms, or organic brain syndromes
Show all 17Show fewer
  • History of neuroleptic malignant syndrome
  • Diagnosis of Parkinson's disease, Alzheimer's disease, multiple sclerosis, cerebral palsy, epilepsy, or mental retardation
  • History of seizures
  • Abnormal blood count for platelets, hemoglobin, absolute neutrophils, aspartate aminotransferase, alanine aminotransferase, creatinine, fasting glucose, and thyroid-stimulating hormone
  • Electrocardiogram recording with QTc interval >475 msec
  • Detectable levels of cocaine or positive screen for stimulants or other drugs considered (determined by the investigator) to be of abuse or dependence
  • Blood alcohol levels superior or equal to 50 mg/dL [or 10.9 mmol/L]
  • Prior participation in an aripiprazole clinical trial
  • Treatment with aripiprazole within 1 month of enrollment
  • Predefined exclusionary laboratory tests
  • Patients with Bipolar Disorder treated with adjunctive therapy other than a stable dose of mood stabilizers (lithium or valproate) must undergo a 30-day washout period for adjunctive therapies, such as antidepressants, prior to randomization.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Canada14 sites

  • Local Institution

    Calgary, Alberta, T2N 2T9

  • Local Institution

    Hamilton, Ontario, L8N 3K7

  • Local Institution

    London, Ontario, N6H 4V1

  • Local Institution

    Markham, Ontario, L6B 1A1

  • Local Institution

    Mississauga, Ontario, L5M 4N4

  • Local Institution

    Montreal, Quebec, H1N 3M5

  • Local Institution

    Montreal, Quebec, H3A 1A1

  • Local Institution

    Montreal, Quebec, H3M 3A9

  • Local Institution

    Montreal, Quebec, H4H 1R3

  • Local Institution

    Pentincton, British Columbia, V2A 4M4

  • Local Institution

    Québec, Quebec, G1R 2W8

  • Local Institution

    Toronto, Ontario, M5T 1R8

  • Local Institution

    Toronto, Ontario, M5T 2S8

  • Local Institution

    Vancouver, British Columbia, V6T 2A1

Other trials in Canada

About this study

Official title: A 16-Week, Randomized, Controlled Trial of the Effect of Aripiprazole Versus Standard of Care on Non-HDL Cholesterol Among Patients With Schizophrenia and Bipolar I Disorder Who Have Pre-existing Metabolic Syndrome

The purpose of this study was to determine whether patients with schizophrenia, schizoaffective disorder, or bipolar I disorder who also have metabolic syndrome have a larger decrease in fasting non-high density lipoprotein (non-HDL) cholesterol levels with aripiprazole than with their current atypical antipsychotic treatment (olanzapine, risperidone, or quetiapine).

Being tested
Aripiprazole, Oanzapine, risperidone, or quetiapine
Medical subject headings
Schizophrenia, Psychotic Disorders, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AripiprazoleDrug

    Also called Abilify, BMS-334039

    Aripiprazole administered orally as tablets, 5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days within a range of 10 to 30 mg daily, for 16 weeks

  • Oanzapine, risperidone, or quetiapineDrug

    Oanzapine, risperidone, or quetiapine administered orally as tablets at prior dosage for 16 weeks

Study groups in NCT00857818
Study groupRoleWhat they receive
AripiprazoleExperimentalNot described
Receives: Drug: Aripiprazole
Control group (Oanzapine, risperidone, or quetiapine)Active comparatorNot described
Receives: Drug: Oanzapine, risperidone, or quetiapine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Levels

    Based on Last Observation Carried Forward data. Non-HDL cholesterol is defined as the difference between total cholesterol and high-density lipoprotein (HDL) cholesterol levels. Fasting non-HDL cholesterol is defined as the measured fasting HDL cholesterol level subtracted from the measured fasting total cholesterol level.

    Measured: Baseline to Weeks 4, 8, and 16

  2. Mean Baseline Fasting Non-HDL Levels

    Measured: At baseline (Day 1)

Secondary outcomes (10)

  1. Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 1 or More AEs

    AE=any new untoward medical event or worsening of a preexisting medical condition that may or may not be causally related to treatment. SAE=any untoward medical occurrence that at any dose results in death; is life-threatening, a congenital anomaly/birth defect, or an important medical event; requires or prolongs inpatient hospitalization, or results in persistent or significant incapacity or drug dependency or abuse.

    Measured: Baseline to Week 16, continuously

  2. Mean Percent Changes From Baseline in Fasting Triglyceride and Total, High-Density Lipoprotein, and Low-Density Lipoprotein Cholesterol Levels

    Measured: Baseline to Week 16

  3. Mean Changes From Baseline in Fasting Glucose Levels

    Measured: Baseline to Week 16

  4. Percent of Participants Showing a Decrease or Increase in Body Weight of 7% or Greater From Baseline

    Measured: Baseline and Weeks 4, 8, and 16

  5. Mean Changes From Baseline in Clinical Global Impression-Severity (CGI-S) Scale

    The CGI-S scale is a 7-point scale that requires the clinician to rate the severity of a patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.

    Measured: Baseline and Weeks 4, 8, and 16

  6. Number of Participants With Potentially Clinically Relevant Changes From Baseline in Blood Pressure, Heart Rate, Hemoglobin Levels, White Blood Cell Count, Differential Count, and Absolute Platelet Count

    Any value falling outside of the normal range will be flagged for the attention of the investigator at the site. The investigator will indicate whether or not a flagged value is of clinical significance.

    Measured: Baseline and Weeks 4, 8, and 16

  7. Mean Change From Baseline in Impact of Weight on Quality of Life (IWQoL-Lite) Scores

    The IWQoL-Lite is a 31-item self-report survey that assesses the impact of weight on quality of life (QoL) in obese patients. Total score=the sum of scores(ranging from 1-5 for each item) for all 31 items. The sum is then rescaled to a 0-100 scoring, with 0 representing the poorest and 100 the best QoL. The survey also assesses improvements in QoL that occur with weight losses of 5% or greater and deteriorations in QoL with weight gain of 5% or greater. A change of 7.8 to 12.0 points from baseline=meaningful improvement. A change of -4.5 to -7.6 points from baseline=meaningful deterioration.

    Measured: Baseline to Weeks 4, 8, and 16

  8. Mean Changes in Weight From Baseline

    Measured: Baseline to Weeks 4, 8, and 16

  9. Median Changes in Body Mass Index From Baseline

    Measured: Baseline to Weeks 4, 8, and 16

  10. Mean Changes in Serum Prolactin Levels From Baseline

    Measured: Baseline to Weeks 4, 8. and 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionMar 2010
  4. Study completionMar 2010

Why it stopped: Slow Accrual

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00857818
Sponsor's protocol ID
CN138-564
Status last verified
Jul 2011
First submitted
6 Mar 2009
Last updated
2 Dec 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aripiprazole and Oanzapine, risperidone, or quetiapine in people with Schizophrenia and Schizoaffective Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 14 sites in Canada.

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 8 inclusion and 17 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 2 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 14 sites in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 21 Jul 2011). 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 (Non-HDL) Cholesterol Levels (time frame: Baseline to Weeks 4, 8, and 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00857818.

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 2 Dec 2013.

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