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

Browse trials for

• Metabolic Syndrome 1,964
• Syndrome 9,217
• Schizophrenia 3,471
• Psychotic Disorders 1,626

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 64 is close to the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.

Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.

Study arms

• Experimental
  Aripiprazole

  Drug: Aripiprazole

• Active comparator
  Control group (Oanzapine, risperidone, or quetiapine)

  Drug: Oanzapine, risperidone, or quetiapine

Interventions

• DrugAripiprazole

  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

  Also known as: Abilify, BMS-334039

• DrugOanzapine, risperidone, or quetiapine

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

Primary outcomes

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.

   Time frame: Baseline to Weeks 4, 8, and 16

2. Mean Baseline Fasting Non-HDL Levels

   Time frame: At baseline (Day 1)

Secondary outcomes

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.

   Time frame: 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

   Time frame: Baseline to Week 16

3. Mean Changes From Baseline in Fasting Glucose Levels

   Time frame: Baseline to Week 16

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

   Time frame: 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.

   Time frame: 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.

   Time frame: 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.

   Time frame: Baseline to Weeks 4, 8, and 16

8. Mean Changes in Weight From Baseline

   Time frame: Baseline to Weeks 4, 8, and 16

9. Median Changes in Body Mass Index From Baseline

   Time frame: Baseline to Weeks 4, 8, and 16

10. Mean Changes in Serum Prolactin Levels From Baseline

    Time frame: Baseline to Weeks 4, 8. and 16

Baseline characteristics

Related links

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