Methods for preventing antipsychotic-induced weight gain

A technology of antipsychotic drugs and drugs, applied in the direction of drug combination, pharmaceutical formula, nervous system diseases, etc.

Inactive Publication Date: 2006-11-01
CORCEPT THERAPEUTICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these studies must still establish a clear and compatible relationship between AP-induced weight gain and specific hormones such as insulin and cortisol

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0099] Example 1: Inhibition or reversal of AP-induced weight gain with mifepristone

[0100] The following examples illustrate how the method of the invention can be practiced.

[0101] patient selection

[0102] Individuals who are intended to be administered chronically with AP or have already been administered chronically and have substantially gained body weight as a result. A patient typically has normal Cortisol levels for his or her age. Dosage regimen and administration of mifepristone

[0103] A glucocorticoid receptor (GR) antagonist, mifepristone, was used in this study. Administered at a dose of 200 mg per day. Subjects were dosed with 200 mg of mifepristone daily for six months and evaluated as described below. The dose can be adjusted if necessary and further evaluated periodically throughout the course of treatment.

[0104] Mifepristone tablets are commercially available, eg, from Shanghai Hualian Pharmaceutical Co., Ltd., Shanghai, China.

[0105] Weig...

Embodiment 2

[0107] Example 2: Measuring Cortisol Levels

[0108] To measure cortisol levels in the patients in Example 1, the afternoon cortisol test measurement was used and served as a baseline cortisol measurement. Cortisol levels were measured on Day 0, two weeks after drug treatment (Day 14), and at each observation up to six months, and at regular observations thereafter.

[0109] Blood Cortisol levels were measured using the "Double Antibody Cortisol Kit" (Diagnostic Products Corporation, Los Angeles, CA). This test is a competitive radioimmunoassay in which 125I-labeled cortisol competes with cortisol from clinical samples at the antibody site and was performed essentially using the manufacturer's supplied reagents and following the manufacturer's instructions . Briefly, blood was collected by venipuncture and serum separated from the cells. Samples were stored at 2-8°C for up to 7 days, or frozen at -20°C for 2 months. Samples were brought to room temperature (15-28° C.) by g...

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PUM

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Abstract

This invention generally pertains to the field of psychiatry. In particular, this invention pertains to the discovery that agents capable of inhibiting the binding of cortisol to its receptors can be used in methods for preventing antipsychotic-induced weight gain. Mifepristone, a potent specific glucocorticoid receptor antagonist, can be used in these methods. The invention also provides a kit for preventing AP-induced weight gain in a human including a glucocorticoid receptor antagonist and instructional material teaching the indications, dosage and schedule of administration of the glucocorticoid receptor antagonist.

Description

technical field [0001] The present invention relates to the discovery of agents which inhibit the biological action of the glucocorticoid receptor and are useful in methods of preventing weight gain induced by antipsychotic drugs. Background technique [0002] Antipsychotic (AP) drugs are the most important therapeutic modality used to treat various psychiatric disorders. In order for these drugs to be most effective, their adverse side effects, especially those associated with long-term administration, must be minimized. However, numerous reports based on extensive clinical studies have shown that 40-80% of patients on chronic AP administration exhibit substantial weight gain, eventually exceeding their ideal body weight by 20% or more ( See, eg, Umbricht et al., J. Clin. Psychiatry 55 (Suppl. B): 157-160, 1994; Baptista, Acta Psychiatr. Scand. 100: 3-16, 1999). This unwanted weight gain can significantly impair the effectiveness of psychosis treatments. First, people wh...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/00A61K9/20A61K31/00A61K31/5513A61K31/565A61K31/567A61K31/569A61K31/575A61K45/06A61P3/04A61P25/00C07J43/00
CPCA61K31/00A61K31/5513A61K31/567A61K31/575A61K45/06A61P25/00A61P25/18A61P3/04A61P43/00A61K2300/00A61K31/56
Inventor 约琵夫·K·贝拉诺夫艾伦·F·斯彻特贝格
Owner CORCEPT THERAPEUTICS INC
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