PRESS RELEASES

Study Suggests Depressed Men May Benefit from Testosterone Replacement Therapy

FOR IMMEDIATE RELEASE:
January 01, 2003

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Belmont, MA - A preliminary study (abstract) published today in the American Journal of Psychiatry suggests that transdermal testosterone replacement gel, in conjunction with conventional antidepressants, may improve mood, anxiety, libido and other aspects of depression in difficult-to-treat men who fail to respond to antidepressants alone. Researchers from McLean Hospital in Belmont, MA, conducted the study in treatment-resistant depressed men with low testosterone levels.

"These results are promising for men who find current antidepressants ineffective," said Harrison G. Pope, Jr., MD, principal investigator in the Biological Psychiatry Laboratory at McLean Hospital. "Based on our observations, low testosterone levels may be unexpectedly common in depressed men who do not respond to conventional antidepressants. Doctors and patients should consider screening for low testosterone in these cases."

In this randomized, placebo-controlled study, investigators added a testosterone transdermal gel to the existing antidepressant medications of depressed men who were not improving with these medications alone. These men were between the ages of 30 and 65, and were selected because they displayed low-normal morning serum total testosterone levels and normal prostate specific antigen (PSA) levels. Of 56 men screened, 24 (43.6%) displayed low-normal morning serum total testosterone levels (<350 ng/dl). Of these men, 22 were randomized into the study and 19 completed the eight-week trial. The investigators administered the Hamilton Rating Scale for Depression (HAM-D), the Clinical Global Impression-Severity Scale (CGI-Severity Scale) and the Beck Depression Inventory (BDI) to assess each subjectís change in depression over two-week intervals.

The subjects randomized to testosterone replacement gel (n = 12) improved significantly more than subjects on placebo (n = 10) on the HAM-D. The improvement was evident on both the psychological aspects of depression (such as depressed mood, guilt and psychological anxiety) and the somatic aspects of depression (such as sleep, appetite and libido). Testosterone replacement gel also was associated with significantly greater rates of decrease in CGI-severity scores. A significant difference was not found on the BDI. Side effects were modest, although one man described increased difficulty in urination and withdrew from the study.

"Our trial, although preliminary, was planned to help guide future studies," said Pope. "More research is needed to carefully assess the long-term benefits and risks of testosterone replacement therapy."

According to data from the National Comorbidity Survey, a seminal U.S. study on the prevalence of mental illness, approximately eight percent of American men over the age of 30 will exhibit major depressive disorder in a given year.1 Antidepressant medication will be partially or completely ineffective for many of these men.

Research support provided by Unimed Pharmaceuticals, Inc., a wholly owned, independently operated subsidiary of Solvay Pharmaceuticals, Inc.

Reference:

1) Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshleman S, Wittchen HU, Kendler KS. Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States. Results from the National Comorbidity Survey. Arch Gen Psychiatry 1994; 51: 8-19.

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