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Halo

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Cipralex Approved in Europe for the Treatment of Obsessive Compulsive Disorder

Yahoo News

Thursday January 18, 12:45 pm ET
An Exciting New Treatment Option for Patients With This Chronic, Disabling Disorder

COPENHAGEN, Denmark, January 18 /PRNewswire/ -- H. Lundbeck A/S is pleased to announce the approval of Cipralex? (escitalopram) in Europe for the treatment of obsessive-compulsive disorder (OCD). The approval is based on two pivotal studies demonstrating that Cipralex? is effective and well-tolerated in the treatment of OCD with the added benefit of encouraging rates of remission and relapse prevention in OCD patients. 1,2 OCD is a chronic, highly debilitating disorder that is characterised by recurrent, distressing thoughts and impulses (obsessions) and/or repetitive behaviours (compulsions).3 It is the 10th leading cause of disability of all medical conditions in the industrialised world and affects all aspects of quality of life.4

"The approval of Cipralex? in OCD is exciting news for patients living with this disabling condition," said Professor Joseph Zohar, Division of Psychiatry, Sheba Medical Center, Tel Aviv, Israel and President of the International College of Obsessive Compulsive Spectrum Disorders (ICOCS). "Society often underestimates the impact of OCD on daily life and it is vital for patients to have access to a treatment that is both well-tolerated and effective in reducing the symptoms and associated social disability that patients with OCD encounter on a daily basis."

One pivotal study by Stein et al., demonstrated that treatment with Cipralex? provided significant symptom relief, improvement in social disability and good tolerability in what was described in the study as a very large cohort of OCD patients. The 24-week study investigated the efficacy and tolerability of Cipralex? and found that:1

- Both 10 and 20mg/daily Cipralex? were efficacious and well-tolerated in the treatment of OCD1

- Compared with placebo, Cipralex? 20mg/day was associated not only with lower symptoms scores mid-way through the study but also with earlier onset, increased response and increased remission rates1

- Cipralex? was better tolerated than paroxetine, with fewer withdrawals from the Cipralex? group due to adverse events1

Another study, by Fineberg et al., was designed to compare the efficacy of Cipralex? with that of placebo in preventing relapse over 24 weeks in outpatients with OCD who had responded to 16 weeks prior open-label treatment with Cipralex?.2 This is important because although 50-60% of patients with OCD currently respond to treatment, only a minority of those patients achieve remission.5

Results included:

- Cipralex? 10 or 20 mg/day was well tolerated by patients with OCD, had an effect on OCD-symptoms during 16 weeks of open-label treatment and significantly reduced the risk of relapse in patients with OCD during continued treatment of up to 24 weeks2

- The primary efficacy analysis showed a statistically significantly superior effect of Cipralex? relative to placebo on the time to relapse of OCD, with a 52% rate of relapse in the placebo group versus a 23% rate in the Cipralex? group2

- The risk of relapsing was 2.7 times higher for the placebo group compared to patients treated with Cipralex?2

"Given the chronic nature of OCD and associated serious disability, we need to focus not only on the acute phase, but also on how to prevent relapse. As the patient needs to take the medication for extended periods of time, the tolerability of the compound is a key factor in increasing patient adherence to treatment." continued Professor Zohar. "Cipralex? is an effective and well tolerated treatment with encouraging data on remission and relapse prevention and is therefore a valuable addition to our current options for OCD therapy."

Notes to Editors

About the clinical studies

Dose finding study:

In a double blind placebo controlled study, 458 OCD patients were randomised to either Cipralex? at one of the two doses (10mg or 20mg), or 40mg paroxetine or placebo. The duration of the study was 24 weeks with a primary efficacy assessment after 12 weeks (acute treatment).1

At week 12 - the primary efficacy endpoint - 20mg Cipralex? showed a statistically significant greater improvement in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) compared to placebo (p<0.005). 10mg Cipralex? compared to placebo was (p=0.052). At week 24 dosages of Cipralex? 10mg (p<0.05) and 20mg (p<0.005) showed a statistically significant greater improvement in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) than in the placebo group - as did paroxetine 40mg (p<0.05).1

Relapse prevention study

The long-term efficacy was further supported by a relapse prevention study, where 320 patients (intention-to-treat), following treatment with Cipralex? for 16 weeks, were randomised to either placebo or Cipralex? for a further 24 weeks of double-blind treatment.2

The primary endpoint was time to relapse. The result of this primary analysis showed a significant difference in favour of Cipralex? (p<0.001). The number of relapses during treatment with Cipralex? (23%) was significantly lower compared to the patients in the placebo group (52%) (p<0.001). The risk of relapsing was 2.7 times higher for the placebo group compared to patients treated with Cipralex?.2

About OCD

OCD affects between 2-3% of the general population and is associated with significant functional disability and economic costs.1 OCD has a number of manifestations but involves having both obsessions and compulsions. A common obsession is around dirt, germs and contamination. As compulsions are acts performed repeatedly in hopes of obtaining relief from obsessions, those with OCD may wash compulsively to the point that their hands become raw and inflamed.

- Up to 2/3 of individuals with OCD suffer from co-morbid depression at some time during their illness6

- Symptomatology often starts as early as childhood or adolescence and affects a majority of the patients for their whole life, requiring long-time care and treatment7

- OCD affects men and women equally3

- OCD often goes unrecognised. On average, people with OCD see three to four doctors and spend 9 years seeking treatment before they receive a correct diagnosis. Studies find that it takes an average of 17 years from the time OCD begins for people to obtain appropriate treatment8

About the ICOCS

The International College of Obsessive Compulsive Spectrum Disorders (ICOCS) is primarily aimed at advancing, promoting and facilitating research into the causes and consequences of obsessive compulsive disorder and obsessive compulsive spectrum disorders. The organisation intends to aid and stimulate mental health professionals and others to develop research projects in this field, and to help coordinate research efforts amongst members.

The ICOCS also intends to increase public health awareness in regard to OCD and OC spectrum disorders with the hope of improving diagnosis and encouraging better deployment of resources for assessment and treatment.

For more information on the ICOCS, please visit www.icocs.org

About Lundbeck

H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of drugs for the treatment of psychiatric and neurological disorders. In 2005, the company's revenue was DKK 9.1 billion (approximately EUR 1.2 billion). The number of employees is approx. 5,000. For further information, visit www.lundbeck.com

References

1) Stein DJ, Tonnoir B, Andersen EW, Fineberg NA. Escitalopram in the treatment of obsessive-compulsive disorder. Data presented at 19th ECNP Congress, September 2006, Paris, France.

2) Fineberg NA, Lemming O, Stein DJ, Tonnoir B. Escitalopram in relapse prevention in patients with obsessive-compulsive disorder. Data presented at 19th ECNP Congress, September 2006, Paris, France.

3) Obsessive Compulsive Disorder. National Institute of Mental Health (NIMH). Last accessed on 23.08.06 from http://www.nimh.nih.gov/Publicat/ocdfacts.cfm

4) Eisen JL, Mancebo MA, Pinto A, Coles ME, Pagano ME, Stout R, et al. Impact of obsessive-compulsive disorder on quality of life. Comprehensive Psychiatry 2006; 47 (4); 270-5.

5) Ballenger JC. Remission rates in patients with anxiety disorders treated with paroxetine. J Clin Psychiatry. 2004 Dec; 65(12):1696-707

6) Fineberg NA, Johansen T, Chamberlain SR. Depression within OCD: from neurobiology and clinical responses toward endophenotypes. University of Hertfordshire, Hatfield, UK.

7) Hollander E. Anxiety and OC spectrum disorders. Mount Sinai School of Medicine, New York USA.

8) About OCD. Obsessive Compulsive Foundation. Last accessed on 23.08.06 from http://www.ocfoundation.org/what-is-ocd.html

Media contacts

For more information, or to arrange a telephone interview with a representative from the International College of Obsessive Compulsive Spectrum Disorders (ICOCS), please contact:


Paul Gittins
Ruder Finn UK Ltd
Tel: +44-207-462-8922
Mobile: +44-7958-533-462
Email : pgittins@ruderfinn.co.uk
 

stargazer

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Curious what else this drug might treat. In the past week, I have experienced a period of fairly deep depression, followed by a neutral period, followed by a hypomanic period with sleeplessness and excessive goal-oriented activity. However, other areas of my life are fine, that I can't quite explain--I've succeeded in overcoming some bad habits that had been holding me back spiritually, and in terms of my self-esteem. I'm also replacing them with positive habits: I've been running again, and I've actually meditated every single day for the past week, without resistance. As a result, my confidence had increased--until tonight, when suddenly I fell prey to symptoms of PTSD, spoiling everything! (I posted about it on my PTSD thread.)

That aside, when I was hypomanic recently, I began editing some pieces of music I had composed, and I am certain that the focus on detail was sympomatic of something very much like OCD. But do I actually have OCD? Probably not. That's why I wonder if cipralex might also treat hypomania.

If I'm not making much sense, it's because my thought processes are unusually scattered this evening.
 

David Baxter

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Cipralex is an SSRI (Selective Serotonin Reuptake Inhibitor), similar to Proizac, Effexor, Celexa, Zoloft, etc. The SSRIs are sometimes used to treat the depressive symptoms in bipolar disorder but usually not alone, since in relieving the depressive symptoms they may also trigger hypomanic episodes.

Several SSRIs are also helpful in the treatment of various anxiety disorders, including OCD and PTSD.
 

stargazer

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In present confusion, I mis-spoke. I am looking for something which will treat PTSD. Maybe the cipralex will also help with depression, which I've been having a lot lately also. The depakote I'm on usually keeps me from having severe hypomania, but it's not full-proof. I think diet and exercise are very important, too. Anyway, my PTSD is what attacked me tonight, and what has me anxious.
 

David Baxter

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One of the SSRIs might help with that, SG. Talk to your doctor about this.
 

stargazer

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Again, I can't see him till the 20th, as he has to come up from the nearest large city. He's only here in town every three months. But I'll talk to him when I see him--about this, and other things.

I just canceled my therapy appointment this morning. Sleep is my absolute priority. I have spent too many nights in my life in this condition.
 

David Baxter

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I just canceled my therapy appointment this morning.

That's unfortunate. It probably would have helped. How long do you have to wait for the next one?
 

stargazer

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I see her every two weeks, but in the case of a cancellation, we often can reschedule to an earlier time, if she has an Opening. I'm still awake, by the way (obviously) so if I can tough it out for another two hours, I can probably still show up. I doubt she's received my e-mails yet, as it is not yet six in the morning in California.

I'm just so out-of-it, intellectually and emotionally, and physically drained from total lack of sleep over the past few days, I am doubtful I can even make it over there and back. Fortunately, though, the bus station is right across the street from me.

I guess what I'm saying is, in my present state, I am having a really hard time making up my mind about anything.

I also sent about fifteen angry e-mails to my friend John, when I was considerably more worked up a few hours ago than I am now. And he has nothing to do with this situation! I think I just needed an outlet for my energy, which was so highly charged at the time as to be unmanageable.
 

David Baxter

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If you think you can make it, it might be a good idea - even if you cut the appointment short. It might be very helpful for your therapist to see you while you're in this state - it could help her to see the full extent of the PTSD.
 
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If you think you can make it, it might be a good idea - even if you cut the appointment short. It might be very helpful for your therapist to see you while you're in this state - it could help her to see the full extent of the PTSD.

I agree. The last appointment I had with my therapist I the most anxious I think I have ever been or at least close to it and I was shaking and just really disconnected and he started talking about the ocd and then he stopped and said, "You don't really want to talk about that do you?" and we started talking about the traumas or at least one of them and PTSD and I started to understand better and I hope he could understand me better.

I hope you can at least make it very soon to your appointment.
 
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About the article, isn't Cipralex Lexapro? That is intersting because of the different meds I have taken that one seemed to help me the most. But I am afraid of the weight gain side effect. Interesting.
 

stargazer

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I agree it will be good for the therapist to see me in this state. Similarly, the director of the teen opera company should hear my student's CD in its current state, despite her insistence that she sing it "perfectly" before he gets to hear it. This way, he can address her issues, and help me correct her problems.

So I'm hanging on. The bus leaves in an hour and a half. I'm going to go get breakfast and maybe coffee. (There's a diner down the corner.)

The cleaning lady is a funny person, and I enjoy talking to her when she gets up to clean the bathrooms. She seems to think I'm a little more savvy than the rest of the clientelle here, and she doesn't yell at me the way she's always yelling at them. She has a humorous sort of unsophistication about her, like a character in a Dickens novel. She's really quite charming in that regard.

This is all totally centering around the mother of the students, though, in my mind. If I offend her, even if I am in the right, I will be crushed. We've had such a positive relationship, for almost three years, and I have been totally taken with the diligence and talent of the girls.

I need to keep the girls at least through the 10th, because they are two of the seven singers on my big recording project. They're irreplaceable. So I hope the mom and dad don't get mad at me. He's also a really big guy, and he's kind of scary.

But I am thinking that after the 10th, if I can afford it, maybe I should just drop the account. I think about the girls all the time, because I don't have enough kids. I even wrote a long poem about it.
 

stargazer

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The last appointment I had with my therapist I the most anxious I think I have ever been or at least close to it and I was shaking and just really disconnected and he started talking about the ocd and then he stopped and said, "You don't really want to talk about that do you?" and we started talking about the traumas or at least one of them and PTSD and I started to understand better and I hope he could understand me better.

Janet, I just saw your post. I am glad you said this. One of my conflicts is: I often don't want to talk about it. And then, conversely, I'll be in some professional situation where you're supposed to leave your personal stuff at home, and I DO want to talk about it. I need to learn how to compartmentalize, and I need to learn what therapy's for, and to appreciate it.

Thank you all for all of your support.
 

Halo

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About the article, isn't Cipralex Lexapro? That is intersting because of the different meds I have taken that one seemed to help me the most. But I am afraid of the weight gain side effect. Interesting.

Yes Janet in the US it is marketed under the name of Lexapro. I know for myself personally being on it for almost 2 years now, I have gained some weight on it but each person is different. I found that the amount of weight that I gained on this medication was not much different than all the others that I have tried in the past. As you probably know, many, if not all of these medications indicate that weight gain is a possible side effect however each person is different and it may or may not happen for all.
 

stargazer

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OK, I know Lexapro. Never taken it, but my old landlady's daughter was on it for depression. I think I've known a couple other people who have taken it too. I was just curious.
 

David Baxter

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I thought that Lexapro was Celexa in Canada - citalopram - which is similar to but not exactly the same as Cipralex (escitalopram).


Edit: Never mind. Janet and Nancy are correct. Lexapro is escitalopram / Cipralex.
 

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