Methods of providing weight loss therapy in patients with major depression
Inventors
Dunayevich, Eduardo • Tollefson, Gary D.
Assignees
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Publication Number
US-10322121-B2
Publication Date
2019-06-18
Expiration Date
Abstract
Disclosed are methods of providing weight loss therapy, particularly for patients suffering from major depression.
Core Innovation
The invention relates to weight-loss therapy for overweight or obese patients who are suffering from major depressive disorder. It provides a method for reducing symptoms of depression by at least 40% in such patients.
The method is carried out by selecting an obese or overweight patient with major depressive disorder and administering a pharmaceutical composition comprising naltrexone (or a pharmaceutically acceptable salt thereof) and bupropion (or a pharmaceutically acceptable salt thereof). The daily dose of naltrexone is about 4 mg to about 50 mg per day, and the daily dose of bupropion is about 30 mg to about 500 mg.
Embodiments described in the content include using assessment of depression symptoms with the Montgomery-Åsberg Depression Rating Scale (MADRS), the Inventory of Depressive Symptomatology (IDS) / IDS-SR, and Clinical Global Impressions-Improvement (CGI-I), along with measurement outcomes such as weight loss. Example 1 describes a 24-week open-label study showing decreases in depression rating measures and weight loss.
Example 3 outlines a multicenter randomized placebo-controlled trial design intended to evaluate this combination therapy in the stated population using defined endpoints and dose groups.
Claims Coverage
The partial content identifies one independent claim. The independent claim covers administering a specific two-active pharmaceutical composition (naltrexone plus bupropion) to obese or overweight patients with major depressive disorder to achieve a depression symptom reduction threshold, using specified daily dose ranges for each active.
Depression symptom reduction in overweight or obese major depressive disorder patients
Selecting a patient suffering from major depressive disorder who is overweight or obese and reducing symptoms of depression of the patient by at least 40%.
Administration of naltrexone plus bupropion within specified daily dose ranges
Administering a pharmaceutical composition comprising naltrexone (or a pharmaceutically acceptable salt thereof) and bupropion (or a pharmaceutically acceptable salt thereof), wherein the daily dose of naltrexone is about 4 mg to about 50 mg per day and the daily dose of bupropion is about 30 mg to about 500 mg.
Overall, the claim coverage is centered on reducing depression symptoms by at least 40% in obese or overweight patients with major depressive disorder through administration of a pharmaceutical composition containing naltrexone plus bupropion at specified daily dose ranges.
Stated Advantages
Reduces symptoms of depression by at least 40% in an obese or overweight patient with major depressive disorder.
Achieves weight loss therapy outcomes in the described patient population, with Example 1 reporting decreases in depression symptom measures and weight loss.
Documented Applications
Weight-loss therapy in overweight or obese patients suffering from major depressive disorder using a pharmaceutical composition comprising naltrexone and bupropion.
Open-label evaluation in a 24-week study assessing depression rating measures (e.g., MADRS/IDS-SR) and weight loss outcomes in female subjects with major depressive disorder and BMI in the described range.
Multicenter randomized placebo-controlled trial design to evaluate naltrexone plus bupropion in the stated population using predefined endpoints and dose groups.
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