No Depression Articles

New data suggest
that Cymbalta (duloxetine HCl) 60 mg to 120 mg once daily delayed the
onset of a new episode of depression in patients who had previously
responded to the medication and who had recurrent depressive
disorder, defined in the study as those patients who experienced at
least three depressive episodes in the previous five years, compared
with placebo (p < .001).?  Results from the 52-week maintenance phase
of the longest controlled duloxetine study completed to date were
presented at a meeting of a major scientific society today.
Additionally, patients who were treated with duloxetine were less
likely (p < .001) to experience a new episode of depression than
those who received placebo (recurrence rates were 14.4 percent vs.
33.1 percent, respectively).
Previous research has shown that up to 85 percent of patients with
depression will experience depressive recurrences.(i) The number of
episodes,(ii) their duration(iii) and the presence of lingering
depressive symptoms increase the risk of recurrence, or future
episodes of depression.(iv)
In the placebo-controlled maintenance phase of the study that
followed initial open-label acute and continuation treatment phases,
the most common adverse events (those occurring in at least 5 percent
of patients in any treatment group) were headache, insomnia,
dizziness, fatigue, back pain, common cold and flu.
Additional Study Findings
– Time to worsening of depressive symptoms was significantly longer (p = .006) in the duloxetine-treated group compared with the placebo-treated group.?  Worsening was defined as a 50 percent increase from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD17) total score and a Clinical Global Impressions of Severity (CGI-S) score of 3 or more at any time during the maintenance phase.
– Patients taking duloxetine experienced less worsening in symptom severity during the 52-week maintenance phase as measured by efficacy measures including the HAMD17 total score and subscales, the CGI-S and the Patient’s Global Impression of Improvement (PGI-I) scales, compared with those taking placebo (p-values < .01).
– Patients taking duloxetine experienced a similar worsening in somatic symptom severity during the 52-week maintenance phase as measured by Visual Analog Scales (VAS) for pain and the Symptom Questionnaire-Somatic Subscale (SQ-SS), compared with those taking
placebo (p-values .05).
– The proportion of duloxetine-treated patients who discontinued the study due to treatment-emergent adverse events during the acute, continuation and maintenance phases was 6.6 percent, 6.1 percent and 4.1 percent, respectively.?  Following were the most common
treatment-emergent adverse events:
- Acute phase: nausea, headache, dry mouth and excessive sweating
– In addition, there was one person who did not complete the acute
phase due to a completed suicide, which was determined by study investigators not to be attributed to treatment.
- Continuation phase: headache, common cold and excessive sweating
- Maintenance phase: headache, back pain and common cold
Methods
The 52-week maintenance phase was preceded by up to 34
weeks of open-label treatment with duloxetine 60-120 mg once daily.
Of the 514 patients initially entered into the study, 288 patients
met response criteria at the end of up to 34 weeks treatment and were
entered into the 52-week, double-blind, maintenance phase of the
study.?  During the maintenance phase, patients were randomly assigned
to receive either duloxetine at the dose to which they had previously
responded, or placebo.
The primary endpoint of the study was time to recurrence of a major
depressive episode during 52 weeks of maintenance treatment, as
assessed by any of the following recurrence criteria: a CGI-S score
/ = 4 and meeting DSM-IV criteria for major depressive disorder;
three consecutive visits meeting re-emergence criteria or 10 total
re-emergence visits; or study discontinuation due to lack of
efficacy.?  Secondary measures included the HAMD17 total score and
subscales, CGI-S and PGI-I scales, SQ-SS and VAS for pain.?  Safety
and tolerability were assessed via analysis of treatment-emergent
adverse events, vital signs, weight, ASEX for sexual functioning and
laboratory measures.?  The primary study manuscript has already been
submitted for review with a view to publication in a peer-reviewed
medical journal.
About Duloxetine
Duloxetine is approved in the United States for the acute and
maintenance treatment of major depressive disorder, the acute
treatment of generalized anxiety disorder, and the management of
diabetic peripheral neuropathic pain and fibromyalgia in adults aged
18 years and older.?  Duloxetine is not approved for use in pediatric
patients.
Important Safety Information
Duloxetine is approved to treat major depressive disorder and
generalized anxiety disorder, and to manage diabetic peripheral
neuropathic pain and fibromyalgia. Antidepressants can increase
suicidal thoughts and behaviors in children, adolescents, and young
adults.?  Patients should call their doctor right away if they
experience new or worsening depression symptoms, unusual changes in
behavior, or thoughts of suicide. Be especially observant within the
first few months of treatment or after a change in dose. Duloxetine
is approved only for adults 18 and over.
Duloxetine is not for everyone. Patients should not take duloxetine
if they have recently taken a type of antidepressant called a
monoamine oxidase inhibitor (MAOI), are taking Mellaril(R)
(thioridazine), or have uncontrolled glaucoma. Patients should speak
with their doctor about any medical conditions they may have
including kidney problems, glaucoma, or diabetes. Patients should
talk to their doctor if they have itching, right upper belly pain,
dark urine, yellow skin or eyes, or unexplained flu-like symptoms,
which may be signs of liver problems. Severe liver problems,
sometimes fatal, have been reported. They should also talk to their
doctor about alcohol consumption. Patients should tell their doctor
about all their medicines, including those for migraine, to avoid a
potentially life-threatening condition. Taking duloxetine with NSAID
pain relievers, aspirin, or blood thinners may increase bleeding
risk.?  Patients should consult with their doctor before stopping
duloxetine or changing the dose and if they are pregnant or nursing.
Patients taking duloxetine may experience dizziness or fainting upon
standing. The most common side effects of duloxetine include nausea,
dry mouth, sleepiness, and constipation. This is not a complete list
of side effects.
For full Patient Information, visit
For full Prescribing Information, including Boxed Warning and
medication guide, visit
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of first-in-class and best-in-class pharmaceutical
products by applying the latest research from its own worldwide
laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Ind., Lilly provides
answers — through medicines and information — for some of the
world’s most urgent medical needs. Additional information about Lilly
is available at
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it
operates globally with 135 affiliates in 47 countries and almost
38,900 employees. Since it was founded in 1885, the family-owned
company has been committed to researching, developing, manufacturing
and marketing novel products of high therapeutic value for human and
veterinary medicine. In 2007, Boehringer Ingelheim posted net sales
of 10.9 billion euro while spending one fifth of net sales in its
largest business segment Prescription Medicines on research and
development. For more information please visit

This press release contains forward-looking statements about the
potential of Cymbalta for the maintenance treatment of major
depressive disorder, and reflects Lilly’s current beliefs. However,
as with any pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization.
There is no guarantee that the product will continue to be
commercially successful. For further discussion of these and other
risks and uncertainties, see Lilly’s filings with the United States
Securities and Exchange Commission. Lilly undertakes no duty to
update forward-looking statements.
(i)? ?  Mueller TI, Leon AC, Keller MB, et al. "Recurrence after recovery from major depressive disorder during 15 years of observational follow-up." Am J Psychiatry 1999;156:1000-1006.
(ii)?  Maletic, V., et al. "Neurobiology of depression: an integrated view of key findings." Int J Clin Pract. 2007 Buy amoxil pills Dec;61(12):2030-40.
(iii) Ibid.
(iv)?  Ibid.
Boehringer Ingelheim
View drug information on Cymbalta.
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