Effect of Short Term Atypical Antipsychotic Administration Compared to Placebo on Hepatic Insulin Extraction

Completed · Phase 1 · Has a placebo group

Conditions studied: Normal Non-fluency

In brief

Within the past 20 years, there has been a striking increase in the incidence of obesity 1;2, type 2 diabetes mellitus (T2DM) 3-5, and cardiovascular diseases (CVD) in the schizophrenic population 6-8 . Large NIH-funded trials indicate that the prevalence of metabolic syndrome is twice to three times greater in schizophrenic patients on a specific class of drug termed the "atypical antipsychotics" (AAPs), of which olanzapine is an example, as compared to matched controls 8. Identification of the pathophysiological mechanisms contributing to metabolic disease in schizophrenic patients on AAPs has been hampered by the inability to differentiate underlying disease from treatment-emergent complications. In addition, despite falling within the same drug class, different AAPs exhibit differential associations with metabolic disease. Olanzapine is one of the AAPs associated with the greatest weight gain and degree of metabolic impairments.

Key facts

Study ID

NCT02447835

Run by

Michael Rickels

People needed

15

Starts

2012-08-01

Expected to finish

2014-12-01

Last updated by the study team

2015-05-19

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and women ages 18-40
• BMI 19-24.5kg/m2
• Systolic BP <130mm Hg
• Diastolic BP <85mm Hg
• Subjects capable of giving informed consent, with no past or present psychiatric history
• Only women on oral contraceptives with constant dosing regimens or Depo-Provera for >3 months, to ensure uniform hormonal delivery throughout the study duration
• No medications except as above noted
• Weight stable
• Minimal exercise regime that includes walking, running or biking

You may not qualify if…

• History of heart disease, colitis, autonomic neuropathy, hepatic or renal disease
• DSM-IV diagnosis of past or present psychiatric history, including clinically significant depression
• Drug/Alcohol dependence, homelessness, or inability to give informed consent
• History of asthma, congenital obstructive bladder, peptic ulcer, vasomotor instability, epilepsy, Parkinsonism, elevated thyroid hormone levels
• Diagnosis of diabetes
• BMI>25 kg/m2
• Prescription medication (excluding the contraceptive methods described above)
• Hemoglobin <11
• Abnormal laboratory tests which are clinically significant per the investigator
• Females pregnant or lactating
• Females: not taking hormonal contraceptives; taking hormonal contraceptives of varying dosage throughout the month
• Currently on a weight loss diet
• Moderate to significant exercise regime that includes swimming, weight lifting or other form of exercise not reproducible within CTRC.

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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