Status:
COMPLETED
Assessment and Comparison of Metabolic Changes in Non-psychotic Adults Taking Iloperidone or Olanzapine or Placebo
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Healthy
Eligibility:
All Genders
18-35 years
Phase:
PHASE4
Brief 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...
Detailed Description
Study hypotheses: 1. Early changes (baseline vs day 3) in leptin will correlate with later changes in weight (at study termination.) 1. Olanzapine will cause the greatest increase in calorie cons...
Eligibility Criteria
Inclusion
- 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
- 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 \< 19, history of BMI \>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
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01920802
Start Date
November 1 2012
End Date
September 1 2014
Last Update
March 20 2017
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032