Valdoxan or Agomelatine for Depression

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Valdoxan or Agomelatine: A new depression treatment

About 40-50% of people taking the current antidepressants, or the SSRIs, stop treatment shortly after starting.  This is because that class of medications has certain significant side effects, like nauseua and sexual dysfunction.

Valdoxan, generic agomelatine, is a new medication that is generating a lot of excitement because it seems to be an effective antidepressant that doesn’t have those problems.

Valdoxan is a synthetic analogue to melatonin, a natural substance your body has that plays a role in sleep regulation.  Chemically, it serves to activate the melatonin 1 and 2 receptors, while also acting as an antagonist to 5-Ht2.  This latter activity may serve to promote release or norepinephrine and dopamine.

It’s important to note that Valdoxan has significantly different chemical action than the selective serotonin reuptake inhibitors (SSRIs).

Possible Advantages

Valdoxan may not have the same rate or degree or type of side effects as traditional antidepressants. It may not cause nausea, sexual dysfunction and other common side effects.

It may start working faster, with some efficacy observed at just two weeks, not the four typically needed for antidepressants.

Both these elements may mean that people will be less likely to want to stop taking it and could start expereincing benefit at an earlier time.  In some studies, only 15% stopped use of Valdoxan, which is much less than the rate traditional antidepressants have.

This may mean a very significant advantage over traditional treatment.

Concerns

Several studies of Valdoxan have not shown significant advantage over placebo.

Because Valdoxan is heavily metabolized by the liver, people with some form of liver damage may experience toxicity.  One study showed that some degree of liver impairment could lead to a 50-fold increase in drug concentration.

Valdoxan may, like the SSRIs, increase risk of suicidal ideation.

Efficacy

The number one question people have about any medication is, how well does it work?  It appears that there have been 7 major studies to date which have analyzed the efficacy of Valdoxan for treating depression, and there are others going on to see if it works for generalized anxiety disorder and other conditions.

Positive studies

One study showed that Valdoxan was significantly more effective as a treatment for depression than Prozac.

A study of 711 people treated for depression showed that it was significantly better than placebo and had effect starting at 2 weeks.  Additionally, that study showed that severely depressed people were more likely to respond to Valdoxan than to Paxil.

Another study of 238 people showed a roughly 55% response rate versus 35% response to placebo.

Negative Studies

Several have also shown little or no benefit over placebo.  An unpublished 6 week long study of 414 patients showed that Valdoxan had a response in 53% of those taking it compared to 47% who responded to placebo.  That same study showed that Prozac did have a significant response.

And another 6 week long study of 607 patients showed that neither Valdoxan or Prozac had benefit for treating depression over placebo.

What it means

Valdoxan is not free from the problems that typical antidepressants have, that sometimes they don’t seem to work much better than placebo.  The studies seem to indicate that it is about as effective as traditional antidepressants while having significantly less side effects and possibly faster onset of action.

These advantages may make it extremely popular.  That said, the concerns around its metabolism have yet to fully be addressed, and there may be other issues that time will reveal.

Antidepressants

There is a lot of controversy around antidepressants.  Antidepressants – the Pros and Cons looks at both sides of the story.

Treatment Resistant Depression

Sometimes depression does not respond to treatment.  Here we present 10 ideas for Treating Treatment Resistant Depression.

Dealing with Anxiety

Depression and anxiety tend to come together.  See The Top 25 Anxiety Tips for ideas on how to deal with anxiety.

6 Comments

  1. Kris

    I’m in my ninth week of treatment with Agomelatine, and unfortunately i have to say that i’m disappointed. At first i thought it was fantastic. I was on Zoloft for two months when i found out that Ago is available in UK, so i rushed to my GP for prescription for it and to my surprise she gave it to me. So i’ve quited Zoloft immediately, waited 2 days and started taking Ago 25mg before bed as prescribed. Maybe there was some kind of improvement in sleep, definitely the first couple of days but nothing dramatic as some of the clinical trials participants reported. What i definitely noticed in the first 1-2 days(and only then) was the clearness of mind, it was like someone striped me of all this bullshit thoughts and preconceptions that cause my depression, anxiety . I could see the world and matters as they really are. To good to be true, and it was to good, it started to shade off day by day, even the sleeping benefits started to decline. Also i noticed some hair lose but wasn’t sure it started before or after Agomelatine, i decided to continue.
    So when i had last 6 of the 28 tablets left i decided to upper the dose to 50 mg(2 tabs before bed). Nothing happened in those 2 days on 50 mg, not even sleep improvement. I didn’t have a chance to test this dose longer cause my doc refused to prescribe me this dose reasoning it is new and untested in real life med, i don’t blame him. Ok so i was back on 25mg and… again first few days very good feeling, clear mind, just as at the beginning of the treatment, then few more days and back to normal. Some three days ago i started having annoying repetitive thought while trying to fall asleep, hair lose continues, headaches towards the end of the days, no anti depressive or anxiolytic effects whats so ever and it’s been 45 days!!!! Today i decided to stop it and BACK TO SSRI’s.
    conlusion: I’m sure it will work for some and not for others, it doesn’t for me, i’m a good responder to ssri’s. When i’ve read headlines of some articles about Agomelatine : “BETTER THAN PROZAC” etc,. i had high hopes, but it’s not.

    Rob
    Lotna22@yahoo.co.uk

  2. Dammit!
    I just spent ages typing a long comment, but when I tried to send it my Internet Explorer did something really weird.
    Did you get it or do I need to retype the whole thing?

  3. admin

    If it hasn’t been posted yet, then likely we didn’t get it – sorry. But would appreciate your taking the time to rewrite it =)

  4. Robin

    I too had high hopes, having tried several SSRIs, each with vile side effects and even worse withdrawal effects. I was stuck on Prozac (some help with my anxiety disorder, negligible effect on my phobias but with the brain flashes, nausea etc making it not the ideal medication for me). On the plus side, initially I experienced excellent sleep and I have to say a much improved sleep pattern still, including increased ability to wake up in the morning. Apart from that, after 4 months, I am resigning myself to disappointment AND a suspicion that it is actually causing depression. Has anyone else experienced this? I haven’t shown what I would consider signs of true depression up to now in my life but lately I feel constantly tearful, have periods of nothingness, am lethargic and generally have no will to get myself out of this. It’s like a personality change.

  5. celia

    I have been on agomelatine and since starting it I have had extreme nausea, hair loss, stomach aches and diorrhea, I have decided to stop taking it as the side effects out weighed any of the benefits I was told it would have, and am still waiting to see happen, which I guess i won’t see now I’ve stopped taking it.

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