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Agomelatine for Depression: A Breakthrough!?

How did I feel when I boned-up on agomelatine? Excited, impressed, out-of-the-loop, miffed, and cautious. Quite a combo, don’t you think?

I was really taken when I read about the efficacy of agomelatine in the treatment of depression. But I gotta’ tell ya’, I felt a little silly because I’d never heard of it.

I’m thinking much of that had to do with agomelatine not being available in the US.

What is Agomelatine?

Agomelatine (brand names: Valdoxan, Melitor, Thymanax) is an antidepressant developed by Servier Laboratories Ltd. It’s been approved for the treatment of adult major depressive disorder in Europe and Australia.

Servier sold the rights to market agomelatine in the United States to Novartis. It’s currently undergoing phase III clinical trials in the US. Novartis says the drug is scheduled for submission to the Food and Drug Administration (FDA) no earlier than 2012 (you gotta’ be kiddin’ me).

Agomelatine is known as a melatonergic agonist and a 5-HT2c antagonist. Yada, yada – bottom-line: it doesn’t work like modern antidepressants. It has no impact upon the (re)uptake of serotonin, norepinephrine, or dopamine.

The chemical structure of agomelatine is very similar to that of melatonin – catch the root name. It’s known as an analogue – a chemical compound that is structurally similar to another but differs slightly in composition.

Fewer Side Effects

Because agomelatine doesn’t increase levels of serotonin; it’s potential for gastrointestinal, sexual, and metabolic side effects is less than traditional antidepressants.

And how ’bout this? Agomelatine has no discontinuation side effects. Want to quit taking it? Do it!

Agomelatine has a positive impact upon sleep. It has no abuse potential.

Performance

It’s been reported that agomelatine has provided relief in the first week of treatment. (Frankly, I almost omitted that because I don’t want to fuel unrealistic hopes.) Agomelatine is rated very high in terms of maintenance of symptom-relief.

That said, there are unpublished randomized controlled trials that have failed to show that agomelatine is more effective than placebo.

By the way, use caution if you suffer from severe kidney and liver disease, or are a senior.

Research Findings Have Its Back

A study featuring agomelatine was published just two days ago in the online edition of The Lancet. The authors of the study are Ian B. Hickie, MD, University of Sydney, Camperdown, Australia and Naomi L. Rogers, PhD, Central Queensland University, Mackay, Australia.

According to Hickie and Rogers…

“Melatonin analogues provide a new and efficacious mechanism for producing notable phase shifts in human beings.”

From Rogers…

“Many of the traditional antidepressant treatments are effective in alleviating the mood and depressive symptoms but other symptoms, such as sleep disturbance, remain. These other symptoms can have a significant impact on quality of life, daily functioning, and also have other health impacts.”

“There is evidence that improving sleep-wake patterns and circadian rhythms improves mood symptoms, and that disturbances to the circadian and sleep-wake systems may worsen mood symptoms. In patients with depression there is evidence that sleep disturbance often occurs prior to the first onset of depressive symptoms and may also be a marker for relapse of symptoms in many patients.”

That’s All Folks!

I don’t know – if you ask me, agomelatine sounds like it’s a breakthrough medicine. But I have to wonder why Servier sold the US marketing rights to Novartis.

chipur readers in Europe and Australia may be using it right now. I wonder, is it worthy of its hype?

Feedback would really be helpful. Just use the comment box…

FYI – Here’s a link to a piece I did on melatonin back in January.