Clinical Trials for BP

[Muddler]

A large number of studies are recruiting for clinical trials for BP. Go to clinicaltrials.gov & search under BP. You'll find reference to 318 studies. Some are as benign as nutritional supplements, others are for Seroquel, genetic studies etc. Take your pick. Makes interesting reading.

We know that BP is a problem condition to treat. Here's your opportunity to do something about it. Some of these trials are international - not only US-based.

[Luna]

One thing puzzles me.
What I'd like to know, particularly with regard to medication trials, is how they handle your current meds. It's easy if what you have isn't working for you and you've tried all the others. I'd take the chance then and enroll. But if they're going to take you off your current meds...? And if they don't, will they actually get accurate results? If I was stable on a combo, I might be prepared to take the new one WITH my own meds (barring no negative interactions). But wouldn't there be too many confounding variables if everyone was on different meds?

BUT what happens if you are randomised to the placebo ONLY? You'd then be unmedicated, and such a trial would never pass ethical scrutiny and approval, (which is mandatory) as it would be an unacceptable risk to your health. Yet most of the studies we still read about, compare the drug with placebo.

The Declaration of Helsinki, (http://www.wma.net/e/policy/b3.htm) a World Medical Assembly document, is an international ethics agreement, pertaining to human experimentation, to protect volunteers from human rights abuses. In recent times (ie I think in the 2000s) concern was raised about the use of placebo. If the trial subject had a condition, for which he needed treatment (which is usually the case, what's the point otherwise?) randomising that subject to placebo only would be very unethical. So they added the following paragraph in 2004:

32. The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention (my emphasis), except in the following circumstances:
* The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or
* Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option.

And the thing with BP is that there is NO standard 'best current proven intervention". Each one is individually tailored. So how do they handle those very confounding variables of volunteers all being on individual "best interventions"? Beats me. But there must be an answer.

[Zooie]

I've spent 14 years being a lab rat for pdocs to practice their voodoo on me with one med after another. Barring the side effects, at least the meds targeted the BPD. The very thought of being the unlucky dupe that had to take a placebo scares the living s*** out of me!

The only trial(s) I would ever consider being a part of would be if I had incurable cancer and had absolutely nothing to lose by trying a new treatment, and I don't think they would use a placebo in that case to boot.

I know they have to test meds on humans at some point, but count me out!

[Luna]

My pdoc currently has two trials running, one for bipolar mania and one for bipolar depression. He's talked to me about both.

The mania trial is testing the efficiency of SeroquelXR alone, or in combination with lithium, for acute mania. As far as I know, SeroquelXR isn't yet available in South Africa, so it's probably a local trial before local release.

The depression trial is to test a new drug, called lorazodone. I can find NOTHING about it online, so it must be brand new. I am totally guessing here, but from the last part of the name, it sounds as if it might be in the same class as trazodone (Desyrel, Molipaxin) and nefazodone (Serzone). From Wiki: "Trazodone is a psychoactive drug of the piperazine and triazolopyridine chemical classes that has anti-depressant, anxiolytic, and hypnotic properties." I'd probably have jumped at this one, before we tried Seroquel but now I don't think so...

On Monday last, the pdoc told me more about the SeroquelXR trial. IF I were to join it, I would be hospitalised for a short period, maybe just for a day. I guess it depends on how severe the mania is. That's no big deal to me. My Wellbutrin and Lamictin would then be stopped. That's a much bigger deal to me. My Seroquel swould be switched to the XR version. I'm interested for mainly one reason and that is whether my akathesia would be reduced by the XR, because of more stable blood levels. And if the XR is better for me, I'd have access to it before release. So I'm asking whoever can answer this from experience: If you had akathesia or Restless Legs Syndrome while taking Seroquel, did a switch to the XR help? Did the XR help more than the immediate release, with other SEs?

The reason I am pondering, is that I know how I get when I'm manic. I'm most agreeable and friendly (except when crossed...) and I could easily just agree to join, if it was suggested to me, without having thought it out carefully. Doctors are supposed to put their patients' needs over the needs of the trial, but doctors also have a vested interest in recruiting patients, since trials are very lucrative for doctors... Given all other treatment options being equal, I'm guessing the doc is more likely to recommend the trial. There's a fine line with these things. The cynical me asks: would he really pick the best option for me?

So far I'm leaning towards not doing it. Why mess with the Wellbutrin/Lamictin/Setoquel combo when it has helped so much? My pdoc pointed out to me that if I became more manic, he'd have to stop the Wellbutrin anyway. There's that. But the prospect of lithium if Lamictin needed to be replaced, doesn't thrill me. However if SeroquelXR as monotherapy proved to work equally well from both sides, that would be very good. And then there's the reckless excitement of doing a drug trial just for the experience; I was on the investigating end for so long, it'd be fun to try the other side...

Anyone else been in clinical trials and pondered these things before joining? What made up your mind, either way?

[Zooie]

Luna, I haven't tried XR but have a comment about getting off your anti-D. Isn't that what Wellbutrin is? If not, just ignore the following.

When they put me on Seroquel last year, they took me off Prozac, my anti-D, because they said Seroquel would target the depression too. Well, all went ok for a bit, but then I fell into the biggest Black Hole I've been in for a while. I can't take enough Seroquel to counteract the depression I guess, and was immediately put back on Prozac.

Just a note I felt I needed to add to your decision. Just be careful gal!

[Luna]

Yup, Wellbutrin is 'my' AD. I just love this stuff. The issue of how much Seroquel and in what form, pales into insignificance, compared with the scary prospect of stopping the WB. ALL three drugs I'm on, target depression: 1. WB, the AD, 2. Lamictin, the mood stabiliser from the depressive side, and 3. Seroquel, the panacea that resists classification, just approved for BP depression.

I think you just made up my mind (thanks!) I suspect if I get any more manic (and I don't go on the trial), the pdoc's next step will not be more Seroquel, but less Wellbutrin. He won't stop it all, just decrease. That's okay, just don't take it all away. I hear what you say about your Prozac. And for that matter, let me just hang on to the Lamictin. I don't think this trial is in my best interests.

And that is another reason for me to rein in the current mania, with the self-help stuff I'm learning...