Saturday, July 7, 2007

Clinical research trial update

It's been 10 weeks since I started a clinical research trial for a new medication. I won't bother with the technical name, but it's sort of a new-and-improved version of Effexor XR. Phase I of the study was double-blind, so I don't know if I was taking the drug or a placebo, but because I'd taken Effexor XR a year ago and gotten sick as a dog, I assumed I was on the placebo.

I was severly depressed when I entered the study and for the first 4 weeks, I felt no improvement, further evidence that I was taking the placebo. Almost overnight though, after I hit the 4-week mark, I started feeling better. Not great, but not bad. At the time I posted about possibly feeling "normal", whatever that means.

Two weeks ago I entered Phase 2, which is the "open-label" phase. I now know for sure that I'm taking 200 mg of the new med (I started with 100 mg during the first week). I was definitely expecting the awful queasiness and nausea this time, but again it didn't happen. How could that be? For the first week I noticed some remnants of Restless Leg Syndrome, but those have quieted down now. So, I'm happy to report that this medication not only hasn't had any horrible side-effects (yet), but it also appears to be working.

Well, actually there has been one side effect that I must mention. The medication has had dulled my appetite substantially. I'm still eating, but much smaller portions. In the 2 weeks since open-label, I've lost 6 lbs and 1 full dress size! I'd gained 20 lbs from the Effexor before, and it took me a year to lose 10 lbs (OK - I really WANTED to lose the weight, but I didn't try THAT hard), so to have lost another 6 lbs in 2 weeks is awesome.

I'm still watching for signs of hypomania, but so far other than this persistent insomnia which is not responding to therapy for sleep apnea, things are looking good.

I realize that this experience may not be the norm, but I wanted to post about it because I've seen so many negative posts about clinical trials and I wanted to report a more favorable experience. I realize that clinical trials are not for everyone, but in some cases, particularly if you are without medical insurance as I was at the time I started, it is definitely worth considering.

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