Psycho-Babble Medication Thread 508689

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Agomelatine Sounds Interesting! UK aproval?

Posted by Tom Twilight on June 6, 2005, at 17:36:27

Agomelatine sounds like an interesting option, a ray of light among all the Cymbaltas and Desvenlafaxines that are flooding the AD markets.

Does anyone have any idea when it will be aproved in the UK? Or America for that matter?

Determination of the dose of agomelatine, a melatoninergic agonist and selective 5-HT2C antagonist, in the treatment of major depressive disorder: a placebo-controlled dose range study
by
Loo H, Hale A, D'haenen H.
Service Hospitalo Universitaire de Sante Mentale et de Therapeutique,
Hopital Sainte Anne, Paris, France; bTrust Headquarters,
St Martin's Hospital, Canterbury, Kent, UK;
cAcademisch Ziekenhuis VUB,
Bruxelles, Belgium.
Int Clin Psychopharmacol 2002 Sep;17(5):239-47

ABSTRACT

Agomelatine (S 20098) has a unique and new pharmacological profile. It is a melatoninergic agonist and selective antagonist of 5-HT2C receptors, and has been shown to be active in several animal models of depression. The aim of this study was to determine the active dose of agomelatine in the treatment of major depressive disorder (DSM-IV criteria). The methodology used was a conventional double-blind design comparing three different doses of agomelatine (1, 5 and 25 mg once a day) with placebo over an 8-week treatment period. Paroxetine was used as the study validator. Seven hundred and eleven patients with a baseline mean score of 27.4 on the 17-item Hamilton Rating Scale for Depression (HAM-D) were included. On the pivotal analysis, the mean final HAM-D total score (Full Analysis Set LOCF) demonstrated agomelatine 25 mg to be statistically more effective than placebo. This was confirmed by other analyses and criteria (responders, remission, subpopulation of severely depressed patients, Montgomery-Asberg Depression Rating Scale, Clinical Global Impression-Severity of Illness). Agomelatine 25 mg alleviated the anxiety associated with depression, as measured on Hamilton Anxiety Scale. Paroxetine was found to be effective on pivotal analysis and most of the secondary criteria used to validate the study methodology and population. Agomelatine, whatever the dose, showed good acceptability with a side-effects profile close to that of placebo. In conclusion, this study demonstrates that agomelatine is efficient in the treatment of major depressive disorder and that 25 mg is the target dose.

 

Re: Agomelatine Sounds Interesting! UK aproval?

Posted by linkadge on June 6, 2005, at 17:52:44

In reply to Agomelatine Sounds Interesting! UK aproval?, posted by Tom Twilight on June 6, 2005, at 17:36:27

Even if it doesn't make it on its own this sounds like a intersting adjunctive to other meds.

It might reverse sleep and sexual side effects of certain meds.


Linkadge

 

Re: Agomelatine Sounds Interesting! UK aproval?

Posted by SLS on June 6, 2005, at 18:03:31

In reply to Re: Agomelatine Sounds Interesting! UK aproval?, posted by linkadge on June 6, 2005, at 17:52:44

> Even if it doesn't make it on its own this sounds like a intersting adjunctive to other meds.

This is exactly the way I feel about ritanserin. We will never see it because it is a drug without an indication. I think it is time that drug manufacturers begin petitioning the FDA for approval of psychiatric drugs that are only efficacious when used as adjuncts. Afterall that's what they do for AEDs like Lamictal, Neurontin, Topamax, Keppra, and Gabitril. Gepirone would have probably been a great adjunct to antidepressant and anxiolytic medications. By itself, it probably does very little.


- Scott


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