Duloxetine ( Cymbalta ) significantly reduced anxiety symptoms in elderly patients with depression, compared with those treated with a sugar pill.

In the eight-week study of people over age 65 with depression, 60 mg of Duloxetine, taken once daily, significantly reduced psychic anxiety symptoms in depressed patients, such as worry, ability to concentrate, tension and irritability, compared to placebo ( mean change 6.2 vs. 0.18 ), as measured by the psychic anxiety question on the Hamilton Depression Scale ( HAMD17 ).

Duloxetine also significantly reduced somatic anxiety -- or physical symptoms often associated with anxiety -- compared with placebo ( mean change of 1.88 vs. 0.99 ), according to the anxiety/somatization subscale of the HAMD17.

" When anxiety symptoms appear in elderly patients with depression it often makes treatment more complicated than when these symptoms emerge alone. This comorbidity is associated with an increased severity of symptoms, including a greater risk for suicide, and often less successful treatment outcomes," explained Olga Brawman-Mintzer, the director of Anxiety Disorders Program at the Medical University of South Carolina.

While depression alone affects two million Americans aged 65 and older, there is considerable overlap between depression and anxiety. Half of those with major depressive disorder actually meet the criteria for an anxiety disorder. Furthermore, one-quarter of those with anxiety disorders meet the criteria for major depressive disorder.

Additional study highlights were:

When elderly patients were analyzed by age:

- Patients under 75 treated with Duloxetine experienced significant improvements in both psychic anxiety symptoms, such as worry and tension, and physical anxiety symptoms, as measured by the anxiety/somatization subscale, compared with those treated with a sugar pill.

- Patients 75 and older treated with Duloxetine showed significant improvements in psychic anxiety, as well. They also showed a numerical advantage on the anxiety/somatization subscale that was not statistically significant, as compared with those treated with a sugar pill.

A statistically significant improvement in the somatic anxiety item of the HAMD17 was not seen in patients treated with Duloxetine.

In this study, Duloxetine was safe and well tolerated, with discontinuations due to adverse events occurring in less than 10 percent of those treated, with no difference between Duloxetine and placebo.

The most common ( equal or greater than 5 percent ) adverse events experienced by patients treated with Duloxetine in this study included dry mouth ( 14.5 percent ), nausea ( 12.6 percent ), constipation ( 10.1 percent ), headache ( 7.2 percent ), dizziness ( 8.2 percent ), diarrhea ( 8.2 percent ), fatigue ( 6.3 percent ) and somnolence ( 5.3 percent ).

Data were gathered from 311 patients with major depression aged 65 and older who participated in a multicenter, parallel, double-blind, placebo- controlled study.
After one week, patients were randomly chosen to receive either Duloxetine 60 mg once daily ( n=207 ) or placebo ( n=104 ) for eight weeks.
At the end of the study, patients entered a one-week, double-blind discontinuation phase where the dose of the study medication was tapered.
A secondary analysis was conducted to measure anxiety using anxiety items 10 ( psychic ) and 11 ( somatic, ) and the anxiety/somatization subscale of the HAMD17.

Serotonin and norepinephrine are two chemicals in the brain and spinal cord called neurotransmitters.
Serotonin and norepinephrine are believed to both mediate core depression symptoms and help regulate the perception of pain.
Disturbances of serotonin and/or norepinephrine may explain the presence of both the emotional and physical symptoms of depression.
Based on pre-clinical studies, Duloxetine is a balanced and potent reuptake inhibitor of serotonin and norepinephrine.
While the mechanism of action of Duloxetine is not fully known, scientists believe its effect on both emotional symptoms and pain perception is caused by increasing the activity of serotonin and norepinephrine in the central nervous system.

Duloxetine is approved in the United States for the treatment of major depressive disorder and the management of diabetic peripheral neuropathic pain, both in adults.
Duloxetine is not specifically indicated for geriatric depression. As duloxetine has not been studied in children, its use is not recommend in those under the age of 18.
In clinical studies, antidepressants increased the risk of suicidal thinking and behavior in children and adolescents with depression and other psychiatric disorders. Anyone considering the use of Duloxetine or any other antidepressant in a child or adolescent must balance the risk with the clinical need. Patients who are starting therapy should be observed closely.

Patients on antidepressants and their families or caregivers should watch for worsening depression symptoms, unusual changes in behavior and thoughts of suicide, as well as for anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme hyperactivity.

In clinical studies of Duloxetine for depression, the most common side effects were nausea, dry mouth, constipation, decreased appetite, fatigue, sleepiness, and increased sweating.
Duloxetine is also approved for the management of neuropathic pain associated with diabetic peripheral neuropathy.
In clinical studies of Duloxetine in these patients, the most common side effects were nausea, sleepiness, dizziness, constipation, dry mouth, increased sweating, decreased appetite, and loss of strength or energy.

Source: Annual Meeting of the American Psychiatric Association. ( APA ), 2005


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