Assessment and Comparison of Metabolic Changes in Non-psychotic Adults Taking Iloperidone or Olanzapine or Placebo
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|ClinicalTrials.gov Identifier: NCT01920802|
Recruitment Status : Completed
First Posted : August 12, 2013
Results First Posted : March 20, 2017
Last Update Posted : March 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: olanzapine Drug: iloperidone Drug: Placebo||Phase 4|
Early changes (baseline vs day 3) in leptin will correlate with later changes in weight (at study termination.)
- Olanzapine will cause the greatest increase in calorie consumption from baseline on the multi-item meal compared with iloperidone or placebo.
- Olanzapine subjects will report the greatest frequency/quantity of eating in food diaries, and report increased preference for calorically dense foods (ie, higher fat content) compared to iloperidone or placebo.
- Early markers of endocrine changes caused by olanzapine will be greater than those caused by iloperidone or placebo, and these early changes will correlate with weight gain.
Olanzapine will have greater effects on glucose homeostasis than iloperidone or placebo, and these effects will be separate from effects on body weight and composition.
- Early signs of metabolic disturbance, including glucose intolerance (greater excursion on OGTT) and insulin resistance (higher plasma insulin) will precede any significant weight gain.
- Early evidence of glucose intolerance and/or insulin resistance will predict greater metabolic derangements with further dosing of olanzapine, as evidenced by exacerbated glucose intolerance on OGTT or higher plasma glucose/insulin levels. These effects may not necessarily parallel weight gain.
- Olanzapine will be associated with greater markers of inflammation than iloperidone or placebo.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Quantitative Assessment and Comparison of Metabolic Changes in Non-psychotic Adults Taking the Antipsychotic Medications Fanapt (Iloperidone) or Zyprexa (Olanzapine) or Placebo|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||September 2014|
5mg BID olanzapine for up to 4 weeks
5mg BID up to 4 weeks
Other Name: Zyprexa
6mg BID iloperidone up to 4 weeks
6 mg BID up to 4 weeks
Other Name: Fanapt
Placebo Comparator: placebo
BID placebo up to 4 weeks
BID up to 4 weeks
- Change in Body Weight [ Time Frame: baseline and 6 week visit ]Delineate a pathophysiological mechanism of antipsychotic induced weight gain
- Change in Adiposity [ Time Frame: Baseline to Day 28 ]Total fat mass (excluding head) from baseline to Day 28
- Change in Leptin [ Time Frame: change in baseline to Day 3 ]Leptin levels measured at Day 3 compared to baseline
- Change Glucose in People Taking Olanzapine or Iloperidone [ Time Frame: Baseline to study termination (about 12 weeks) ]To quantify, prospectively, change in glucose from baseline to Day 28
- Change in Insulin [ Time Frame: Baseline to Day 28 ]Change in Insulin levels from baseline to Day 28
- Insulin Resistance [ Time Frame: Baseline to Day 28 ]Homeostatic model assessment for Insulin Resistance (HOMA-IR) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin.
- Change in Food Intake [ Time Frame: Baseline to Day 28 ]Total grams of food consumed
- Change in Lipid Metabolism [ Time Frame: Baseline to Day 28 ]Change in lipid metabolism as measured by cholesterol/HDL ratio
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920802
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Jeffrey Lieberman, MD||New York State Psychiatric Institute|