Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Patent
1998-06-18
1999-09-28
Jarvis, William R. A.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
A61K 3155
Patent
active
059589213
DESCRIPTION:
BRIEF SUMMARY
This invention relates to a method for treating depression using
Major Depressive Disorder is associated with a high mortality. Up to 15% of individuals with severe Major Depressive Disorder die by suicide. Epidemiological evidence also suggests that there is a fourfold increase in death rates in individuals with Major Depressive Disorder who are over age 55 years. Individuals admitted to nursing homes with Major Depressive Disorder have a markedly increased likelihood of death in the first year.
Depression is a prevalent condition. The lifetime risk for Major Depressive Disorder in community samples has varied from 10% to 25% for women and 5% to 12% for men. The prevalence of Major Depressive Disorder appear to be unrelated to ethnicity, education, income, or marital status.
The ompound is described in U.S. Pat. No. 5,229,382 ('382), herein incorporated by reference in its entirety.
The presently claimed invention provides a method for treating depressive signs and symptoms comprising administering an effective amount of a compound to a patient in need thereof.
Additionally, the present invention provides a method for treating major depression comprising administering an effective amount of a compound to a patient in need thereof. is a compound of Formula(I): ##STR1## and is described in the '382 patent. The '382 patent teaches that can be useful for the treatment of psychotic conditions and mild anxiety states.
Surprisingly, and in accordance with the present invention, Applicants have discovered that can be useful for treating depressive signs and symptoms.
The usefulness of for treating depressive signs and symptoms can be demonstrated by clinical trial.
Such effectiveness for the treatment, amelioration and/or prevention of depressive signs and symptoms was shown in the following clinical trial:
The study was an international double-blind, parallel trial conducted in one thousand nine hundred ninety six (1,996) subjects. Individuals were randomized 2:1 to either or haloperidol (5 to 20 mg per day) for six weeks. Subjects were evaluated weekly using the MADRS standardized assessment tool. Depressive signs and symptoms were related to suicidality. was statistically significantly better than haloperidol in baseline endpoint MADRS total score change. A statistically significant number of subjects in the haloperidol treatment group demonstrated a worsening of depressive signs and symptoms. effective over a wide dosage range, the actual dose administered being dependent on the condition being treated. For example, in the treatment of adult humans, dosages of from about 1 to 40 mg, and most preferably 5 to 30 mg per day may be used. A once a day dosage is normally sufficient, although divided doses may be administered. For treatment of depressive signs and symptoms in a human, a dose range of from about 2.5 to 30 mg, preferably 5 to 25 mg per day is suitable. Radiolabelled can be detected in the saliva and thus the compound can potentially be monitored in patients to assess compliance.
The ompound will normally be administered orally for the treatment of depressive signs and symptoms, or may be administered by injection and, for this purpose, it is usually employed in the form of a pharmaceutical composition. Other suitable formulations are taught in the '382 patent.
As used herein, the term "mammal" shall refer to the Mammalia class of higher vertebrates. The term "mammal" includes, but is not limited to, a human. The term "treating" as used herein includes prophylaxis of the named condition or amelioration or elimination of the condition once it has been established.
For the treatment of depressive signs and symptoms, the patient may be a non-human mammal. In such instances, the compound may be administered as a feed additive, tablet, or transdermally.
Methods for preparing are provided by the '382 patent; however, the following examples may be instructive as well.
EXAMPLE 1
##STR2##
In a suitable three neck flask the following was added: For example, the preparation of the Intermediate 1 is taught in t
REFERENCES:
patent: 5229382 (1993-07-01), Chakrabarti et al.
patent: 5605897 (1997-02-01), Beasley, Jr. et al.
Eli Lilly and Company
Jarvis William R. A.
Palmberg Arleen
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