Phase 4
Completed N=31
Assessment and Comparison of Metabolic Changes in Non-psychotic Adults Taking Iloperidone or Olanzapine or Placebo
Healthy
Source: ClinicalTrials.gov NCT01920802 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Change in Body Weight — 3.2; 0.8; 0.4 kg
◆ Published Evidence
Established
29citations · ~4 / year
Pathophysiology of drug induced weight and metabolic effects: findings from an RCT in healthy volunteers treated with olanzapine, iloperidone, or placebo.
Summary
The purpose of this pilot randomized clinical trial is to begin to delineate the pathophysiological changes associated with antipsychotic associated metabolic side effects. The study will be performed in 36 healthy people between the ages of 18 and 30, who have never taken an antipsychotic, will undergo baseline laboratory tests before being randomized to 5mg BID of olanzapine or 6mg BID of iloperidone or placebo to take for up to 4 weeks. The primary outcome measure will be a correlation of early changes in leptin with weight gain. We will also record changes in food intake, resting metabolic rate, oral glucose tolerance and fasting insulin and glucose levels, lipids and inflammation markers. Subjects will be followed closely to monitor for safety throughout the 4-week study and will be discontinued if there is a medically significant change in metabolic status or other antipsychotic side effects. Metabolic assessments will be performed again at the time of discontinuation or at the end of an 4-week period, and change from baseline in the two treatment groups will be compared.
Linked Publications
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Pathophysiology of drug induced weight and metabolic effects: findings from an RCT in healthy volunteers treated with olanzapine, iloperidone, or placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight |
3.2; 0.8; 0.4 | — |
| PRIMARY Change in Adiposity |
11942; 14741; 11690; 13312; 16366; 12081 | — |
| SECONDARY Change in Leptin |
2.47; 1.76; 1.16 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female between the ages of 18-35 with no history of any Axis-I diagnosis
- Does not meet criteria for substance abuse or dependence in the past six months
- Female subjects will use barrier-method, non-hormonal contraception
- Capacity to understand all the relevant risks and potential benefits of the study (informed consent)
- Must be able to speak and read English
Exclusion Criteria
- Current or past Axis I psychiatric diagnosis, including alcohol or substance abuse or dependence (except nicotine or caffeine), but not including minor Axis I disorders (e.g. simple phobia)
- Lifetime use of psychotropic medications, including antipsychotics, antidepressants, mood stabilizers, and anxiolytics
- Presence or history of medical or neurological illness that, in the judgment of the investigator, could influence the results of the study
- Diagnosis of diabetes, hemoglobin A1C > 6.5, hypertension, or dyslipidemias, or elevated random or fasting glucose, abnormal lipid levels, BP 130/85
- BMI 25 or 35, and/or waist circumference >35 inches for females, 40 inches for males
- Subjects who are pregnant or breast-feeding or planning to become pregnant during the study
- Acute suicidality
- Meets criteria for a Diagnostic and Statistical Manual, Version 4 (DSM-IV) defined eating disorder
- Use of, or clinical indication for, one or more of the following medications: lithium, anti-epileptic medication, steroids (oral or inhaled), stimulants, serotonin reuptake inhibitors, mirtazapine, tricyclic antidepressants, thyroid supplementation, sibutramine, metformin, thiazolidinediones, beta-blockers, clonidine, niacin
- Subjects who have had >10% change in their body weight within the three months prior to enrollment
- HIV positive subjects
- Presence of mental retardation or pervasive developmental disorder
- History of recent (within 6 months) significant self-injurious behavior or violence
- Daily multivitamin or B-complex vitamin use
- A known history of dieting and difficulty with weight loss
- A strong family history of diabetes and/or heart disease
- History of congenital long QT syndrome or prolonged corrected QT interval (QTc) on screening EKG (>450ms)
- Concomitant use of any medication that inhibits 2D6 or 3A4 metabolism
- Low serum potassium or magnesium
Data sourced from ClinicalTrials.gov (NCT01920802) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.