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Duloxetine Study Shows Reduction in Core Anxiety Symptoms in Patients With Generalized Anxiety Disorder

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Duloxetine Study (Cymbalta), Shows Reduction in Core Anxiety Symptoms in Patients With Generalized Anxiety Disorder

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Drug Trials and Comparisons

MIAMI, March 24 /PRNewswire-FirstCall/ -- A new study of approximately 500 patients evaluated the safety and efficacy of the antidepressant Cymbalta® (duloxetine HCl) on the core anxiety symptoms in patients with generalized anxiety disorder. Cymbalta significantly reduced core anxiety symptoms and associated painful physical symptoms and improved functional impairment associated with the illness. Results will be announced on Saturday, March 25, in two separate presentations(i,ii) at the Anxiety Disorders Association of America (ADAA) Annual Conference.

In this nine-week study, Cymbalta significantly improved core anxiety symptoms such as anxious mood, fears and tension by 51 percent in patients taking 60mg/day and by 50 percent in patients taking 120mg/day compared to an improvement of 32 percent in patients taking sugar pill. Patients taking both 60mg/day and 120mg/day had significantly greater response and remission rates compared to patients taking sugar pill. In addition, Cymbalta significantly reduced overall pain by 41 percent and 37 percent respectively, compared to 16 percent in patients taking sugar pill. Cymbalta patients also reported greater improvement in quality of life as measured by the Sheehan Disability Scale, Quality of Life Enjoyment and Satisfaction Questionnaire and European Quality of Life 5 Dimensions, including improved ability to perform everyday activities at work, home, and in social situations compared to sugar pill.

"While it is important to evaluate anxiety symptoms such as excessive worry and irritability, it is also important to evaluate associated painful physical symptoms and functioning because many patients also report these symptoms," said Christer Allgulander, MD, associate professor, senior lecturer, Karolinska Institutet, and lead author on the study. "These data suggest that not only was Cymbalta able to significantly improve the core anxiety symptoms, but it also reduced painful physical symptoms associated with the disorder and improved functioning resulting in improved quality of life."

"We are encouraged by these results that suggest Cymbalta may address a broad range of core anxiety symptoms and the associated physical symptoms that are often reported in patients with generalized anxiety disorder," said James Russell, MD, medical advisor, Eli Lilly and Company.

Study Highlights

* Compared to sugar pill, patients receiving Cymbalta 60mg/day and 120mg/day experienced significant improvement in symptom severity and disability associated with generalized anxiety disorder, including:

-- Significantly greater improvement in the severity of anxiety symptoms, such as anxious mood, fears and tension, as measured by the Hamilton Anxiety Scale. (average improvement 60mg = 51%, 120mg = 50%, sugar pill = 32%)

-- Greater response rates (58%, 56%, 31%, respectively)

-- Greater sustained improvement rates (64%, 67%, 43%, respectively)

* Patients receiving Cymbalta 60mg/day and 120mg/day experienced greater remission rates compared to those receiving sugar pill (31%, 38% and 19%, respectively).

* Compared to sugar pill, patients receiving Cymbalta 60mg/day and 120mg/day reported significant improvement in ratings on the Visual Analogue Scale for Pain for each of the following pain items:

-- Overall pain (average improvement 60mg = 41%, 120mg = 37%, sugar pill = 16%)

-- Headaches (34%, 38%, 13%, respectively)

-- Back pain (44%, 46%, 14%, respectively)

-- Shoulder pain (47%, 43%, 19%, respectively)

-- Interference due to pain (39%, 41%, 10%, respectively)

-- Pain during waking hours (42%, 43%, 12%, respectively)

* In this study, the most common adverse events (occurred at a rate of greater than or equal to 5 percent and at least twice the rate of placebo) were nausea, dizziness, dry mouth, fatigue, hyperhidrosis, insomnia, constipation, diarrhea, decreased libido, anorexia, somnolence, vomiting and sedation.

Methods

In this study of patients with generalized anxiety disorder, 168 patients were randomly assigned to receive 60mg of Cymbalta a day, 170 patients received 120mg of Cymbalta a day and 175 patients received a sugar pill. Patients with a recent diagnosis (within six months) of major depression were excluded from this study. The primary endpoint of the study was effect on anxiety symptoms as measured by the Hamilton Anxiety Scale (HAMA). Changes from baseline to endpoint were analyzed using ANCOVA. Secondary measures included effects on associated pain and functioning. Pain was assessed using a Visual Analogue Scale. Functional outcomes, such as the ability to complete everyday activities at work, home, and in social situations, were measured using the Sheehan Disability Scale (SDS), the Quality of Life Enjoyment and Satisfaction Questionnaire short form (Q-LES-Q-SF) and the European Quality of Life 5 Dimensions (EQ-5D).

About Generalized Anxiety Disorder

Approximately four million Americans are diagnosed with generalized anxiety disorder each year.(iii) Symptoms persist for at least six months and can include exaggerated worry or chronic anxiety and irritability, which can lead to poor concentration, and procrastination, as well as physical symptoms like muscle tension, fatigue and nausea.(iv) Episodes of generalized anxiety disorder may be brought on, or worsened by, stressful life events. The illness also tends to be chronic with periods of exacerbation and remission.(v)

About Cymbalta

Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core depression symptoms and help regulate the perception of pain. It is common for anxiety disorders to be associated with other disorders, such as depression.(vi)

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 due to increasing the activity of serotonin and norepinephrine in the central nervous system.

Cymbalta is approved in the United States for the treatment of major depressive disorder and the management of diabetic peripheral neuropathic pain, both in adults. Cymbalta is not approved for use in pediatric patients.

Important Safety Information

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 Cymbalta 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 for worsening depression symptoms, suicidal thoughts or behavior, or unusual changes in behavior. Cymbalta is not approved for use in patients under the age of 18.

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. Call the doctor if you have thoughts of suicide or if any of these symptoms are severe or occur suddenly. Be especially observant at the beginning of antidepressive treatment or whenever there is a change in dose.

Prescription Cymbalta is not for everyone. People who are allergic to Cymbalta or the other ingredients in Cymbalta should not take it. If you have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI), are taking Mellaril® (thioridazine) or have uncontrolled narrow- angle glaucoma, you should not take Cymbalta. Talk with your doctor before taking Cymbalta if you have liver or kidney problems, glaucoma or consume large quantities of alcohol. Women who are pregnant should talk with their doctor before taking Cymbalta. Nursing while taking Cymbalta is not recommended. Tell your doctor if you are taking other prescription or nonprescription medications.

In clinical studies of Cymbalta for depression, the most common side effects were nausea, dry mouth, constipation, decreased appetite, fatigue, sleepiness, and increased sweating. Nausea was the most common side effect. For most people, the nausea was mild to moderate, and usually subsided within one-to-two weeks. Cymbalta is also approved for the management of neuropathic pain associated with diabetic peripheral neuropathy. In clinical studies of Cymbalta 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. In all clinical trials, most people were not bothered enough by side effects to stop taking Cymbalta. Your doctor may periodically check your blood pressure. Don't stop taking Cymbalta without talking to your doctor.

For full Patient Information, visit www.Cymbalta.com.

For full Prescribing Information, including Boxed Warning, visit http://www.cymbalta.com/.

(i) Duloxetine as an Effective Treatment for Improving Painful Physical Symptoms and Functioning Associated with Generalized Anxiety Disorder; C Allgulander, H Koponen, J Erickson, Y Pritchett, M Detke, S Ball, J Russell

(ii) A Fixed Dose Study of the Efficacy and Safety of Duloxetine for the Treatment of Generalized Anxiety Disorder; H Koponen, C Allgulander, Y Pritchett, J Erickson, M Detke, S Ball, J Russell

(iii) National Institute of Mental Health. "Facts About Generalized Anxiety Disorder." Available at: http://www.nimh.nih.gov/publicat/gadfacts.cfm. Accessed on: February 6, 2006

(iv) National Mental Health Association. "Anxiety Disorders." Available at: http://www.nmha.org/pbedu/anxiety/anxdis.cfm. Accessed on: February 7, 2006

(v) APA. "Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition." 1994, pp 472-476.

(vi) Anxiety Disorders Association of America "Medications for Anxiety Disorders" Available at: http://www.adaa.org/GettingHelp/AnxietyDisorders/chart.htm. Accessed on March 13, 2006.

Source: Eli Lilly and Company

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I have GAD, and will be the first to admit that it really does hold the anxiety down. When something happens that would normally make me go into a tailspin, I feel a very gentle amount of anxiety. It's just enough to let me know that I need to do something!

Jackie :hearts:

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I have found that cymbalta at the 60mg dosage for me has not helped much if at all with anxiety attacts for me.

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MomOf7: Have you asked your doctor about increasing your dosage? I notice a few people on this board state that they have been prescribed a higher dosage. I think one person talks about it below under "Cymbalta Success Stories" and another under the blog about "How Cymbalta takers are doing".

I have found that cymbalta at the 60mg dosage for me has not helped much if at all with anxiety attacts for me.

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I know I had to be on Lexparo for 7 mo. for the anxiety to go down and am wondering if this is true for Cymbalta.

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I have been taking Cymbalta now for over a year, 60 mg. a day. Anyone here on 90 mg. a day? Cymbalta not helping me at all. I have depression,lots of phobias,ocd,social phobia is getting really bad,....thanks.

Duloxetine Study (Cymbalta), Shows Reduction in Core Anxiety Symptoms in Patients With Generalized Anxiety Disorder

CYMBALTA.jpg

Drug Trials and Comparisons

MIAMI, March 24 /PRNewswire-FirstCall/ -- A new study of approximately 500 patients evaluated the safety and efficacy of the antidepressant Cymbalta

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Dk6217, I'm sorry to hear the the Cymbalta is not working for you. Did it seem to work for awhile and now it's not? I was told that the therapeutic dosage is anywhere from at least 60-90 mg. a day. Have you asked your doctor if you can increase your dosage? I believe there are some people who are members of this forum who take 90 mg. or more successfully, so hopefully they will see this and let you know how they are doing. I'm certainly not an expert since I've only been on it for a little over a month, although it seems to be helping me quite a bit.

I have been taking Cymbalta now for over a year, 60 mg. a day. Anyone here on 90 mg. a day? Cymbalta not helping me at all. I have depression,lots of phobias,ocd,social phobia is getting really bad,....thanks.

Duloxetine Study (Cymbalta), Shows Reduction in Core Anxiety Symptoms in Patients With Generalized Anxiety Disorder

CYMBALTA.jpg

Drug Trials and Comparisons

MIAMI, March 24 /PRNewswire-FirstCall/ -- A new study of approximately 500 patients evaluated the safety and efficacy of the antidepressant Cymbalta

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My GP recently prescribed me Cymbalta and gave me samples. The first night I had an incredible anxiety attack. I figured it was a reaction, took a Xanax and managed to go to sleep and wake up normal (for a horribly depressed individual.) Is this a fluke and should I try it again, or should I take this as a sign and ask for a different med?

Let's All Heal,

Tony

Duloxetine Study (Cymbalta), Shows Reduction in Core Anxiety Symptoms in Patients With Generalized Anxiety Disorder

CYMBALTA.jpg

Drug Trials and Comparisons

MIAMI, March 24 /PRNewswire-FirstCall/ -- A new study of approximately 500 patients evaluated the safety and efficacy of the antidepressant Cymbalta

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I forgot to mention that I had previously tried Cymbalta for about two weeks (for chronic pain and eleven year non-stop headache from viirus) before I was majorly depressed like I am now and it made me feel just kind of numb in my mind and in certain parts of my anatomy. Did I not give it a long enough chance and, of course, things are very different now. It gave me an anxiety attack at night on the first pill this time, which it did not do before. Has anyone else experienced these things and do you think this medication is not for me? Has anyone with these reactions had any success with any other drug?

Get Good,

Tony

Duloxetine Study (Cymbalta), Shows Reduction in Core Anxiety Symptoms in Patients With Generalized Anxiety Disorder

CYMBALTA.jpg

Drug Trials and Comparisons

MIAMI, March 24 /PRNewswire-FirstCall/ -- A new study of approximately 500 patients evaluated the safety and efficacy of the antidepressant Cymbalta

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I had increased anxiety when I first took Cymbalta, but nothing as serious as an anxiety attack. I stuck with it and am now doing great. I'm being treated for GAD. I have had other SSRIs/SNRIs (Zoloft and Lexapro) give me that type of reaction (panic attack) and I personally chose not to stay on them. You may be braver than I am, but since I felt like it defeated the purpose, I chose to try something else. I've seen many people though who stuck with it and were glad they did, so maybe you should get your MDs opinion.

I forgot to mention that I had previously tried Cymbalta for about two weeks (for chronic pain and eleven year non-stop headache from viirus) before I was majorly depressed like I am now and it made me feel just kind of numb in my mind and in certain parts of my anatomy. Did I not give it a long enough chance and, of course, things are very different now. It gave me an anxiety attack at night on the first pill this time, which it did not do before. Has anyone else experienced these things and do you think this medication is not for me? Has anyone with these reactions had any success with any other drug?

Get Good,

Tony

Duloxetine Study (Cymbalta), Shows Reduction in Core Anxiety Symptoms in Patients With Generalized Anxiety Disorder

CYMBALTA.jpg

Drug Trials and Comparisons

MIAMI, March 24 /PRNewswire-FirstCall/ -- A new study of approximately 500 patients evaluated the safety and efficacy of the antidepressant Cymbalta

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hi my names joe please PM me to help me with this please

i was just put on 30mg for a week just took my first 30mg today and

60mg for the next week. im also on wellbutrin xl 300mg. klonopin 2mg

for 30 days and thats the last time the doc is gonna give me another

script. so will the cymbalta help as good as the klonopine. the

klonopine helps so much for my socian anxiety. so im gonna be out of

klonopine in 15 days. so is the cymbalta gonna help me cause i have

home schhol because of the anxiety i had i just couldnt stand being

around so many ppl i would just strar sweating shaking. so what else

is out there that could help me. i have server anxiety an social

phobia. and i hate it so much. and when i run out of my klonopin i

take my ambein because it helps a lot for my anxiety a lot.

please email me back please. Joe D.

ps. im only 17 years old and i just wanna get better or i cant take

this much longer its destroying my life

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hi my names joe please PM me to help me with this please

i was just put on 30mg for a week just took my first 30mg today and

60mg for the next week. im also on wellbutrin xl 300mg. klonopin 2mg

for 30 days and thats the last time the doc is gonna give me another

script. so will the cymbalta help as good as the klonopine. the

klonopine helps so much for my socian anxiety. so im gonna be out of

klonopine in 15 days. so is the cymbalta gonna help me cause i have

home schhol because of the anxiety i had i just couldnt stand being

around so many ppl i would just strar sweating shaking. so what else

is out there that could help me. i have server anxiety an social

phobia. and i hate it so much. and when i run out of my klonopin i

take my ambein because it helps a lot for my anxiety a lot.

please email me back please. Joe D.

ps. im only 17 years old and i just wanna get better or i cant take

this much longer its destroying my life

Joe,

I can't say for certain that the Cymbalta is going to help you with your social anxiety, but it is prescribed for anxiety, and it has helped me with mine. I do think it is a better choice than Klonopin for anxiety, but that is just an opinion. I wouldn't expect Cymbalta to start helping you immediately as you've felt with the Klonopin, because it can take 6-8 weeks for it to become fully active and balanced in your system. I am glad I'm taking it.

I'm sorry that you are feeling so down, but you are doing the right thing by working on getting help. Continue to let us know how you are doing and read some of the other posts. It might give you some the answers and help you are looking for.

Sincerely,

Maddie

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I have GAD, and will be the first to admit that it really does hold the anxiety down. When something happens that would normally make me go into a tailspin, I feel a very gentle amount of anxiety. It's just enough to let me know that I need to do something!

Jackie :hearts:

I found it held the anxiety down a little too much a first. I felt too loosey-goosey. Now (four weeks in) the anti-anxiety effects are lessening (at the same time the ant-depressant effects are picking up). It's at about the right amount now, but I'm concerned it will continue to drop.

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I've been on this med for 4 years, and it's still working well. I was concerned that after a couple of years, the effects would 'poop' out and I would have to increase the dose, but it's fine!

Jackie

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That's good to know. I think things have stabilized somewhat. I no longer feel "stoned" calm and I am getting mildly anxious, but you need some of that to function in the world or you are just a puddle of goo, and I'm still better able to shrug my shoulders and say "**** it." The anti-d effects do seem to be picking up. I've had my mood plunge a couple of times, but it doesn't dive as deep, and seems to struggle back up quicker. And when I'm up, wow. :hearts: Didn't someone call Cymbalta "sunshine in a bottle"?

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Im with JKM on the anxiety thing, I was a raving lunatic for years and years when it came to anxiety..and after I got on cymbalta--what would normally throw me into a raging fit of despair mixed with worry and throwing things and yelling and dwelling and crying and really really freaking out...now I only feel a mild amount of anxiety. Truely, I am NOTHING like I used to be, and I credit alot of it to cymbalta. of course I think working with a therapist and doctors helped a whole lot, but getting on cymbalta is something I should have done a long time ago.

I have noticed after almost 5 months of being on it that some of my problems have somewhat peeked their heads out a little more than I would like lately but at this point Im just so grateful that I feel better and Im different than I used to be that Im kinda just dealing with it lol.

Im just riding that train....

-Sweet P

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I have been on Cymbalta for 2 1/2 years now and my experience on it has been mostly positive. The only problem is that sometimes (about once every couple of weeks) my anxiety still gets the best of me and I need to take a Xanax or something to calm me down. I am on the highest effective dosage according to my doctor (120 mg) so I know that the next time I go in with this complaint, I will be switched to something else. I've come down off of a different med before and it was awful, so I'm worried about having to be (or at least appear to be!) functional while going through that. I'm not really sure if I should just wait it out and see if things get better over time, or have my doctor switch me to something else....is this as good as it gets??

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Kateach

Some time has passed since your post, if you are still active on the forum I would like to hear how your are doing with cymbalta. I'm on 60mg and think I may need a higher dose or something else / additional. Your comments would be appreciated. Thanks!

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Maddielouise. I am now on 90 mg and things are going good. I feel a little tired and my mouth is dry again. I'll go back to my shrink for a follow up in 2 months. I foresee no problems and expect side effects to lessen by then. Thanks !

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I had increased anxiety when I first took Cymbalta, but nothing as serious as an anxiety attack. I stuck with it and am now doing great. I'm being treated for GAD. I have had other SSRIs/SNRIs (Zoloft and Lexapro) give me that type of reaction (panic attack) and I personally chose not to stay on them.

...............................................................................................

Brodon

Edited by Brodon

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It doesn't help me with anxiety. Try it with some Xanax. For me, it does the trick.

Hi Crazyguy,

I think it's worth asking your Dr. about an increase to 90 mg. if you don't think 60 is helping.

Sincerely,

MaddieLouise

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I been on Cymbalta (Duloxetine) for 9 years this has been a miracle for me. It helps with anxiety, my chronic pain, my fibromyalgia, my bipolar now just find something to help with anger I'd be perfect. The only side effect I have had is nightmares if I forget to take it that's it. I love my medicine.

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