Would you participate in a clinical medical research study?

[GGT]

Yes or No. Why or Why Not.

Under what circumstances or protocol?



I might have an 'opportunity' to be a guinea pig test subject at University of Pennsylvania's medical psychiatry department. (I'm told that's the dept. in charge, but it was a referral from a referral so it's not quite clear yet.) They're in the beginning stages of creating a study of 18-65 year olds with histories of various types of depression/anxiety/bipolar diseases. It's not a typical medication trial, but something more related to the endocrine system (hormone or insulin therapy, or something similar).

All I know so far is that subjects have to be medication-free for 5 X the half life of any current prescription; all pre-study blood work, radiology, diagnostics and complete physical exam are paid by the university (or their grant funds); subjects are required to travel to Philly once a month to be re-evaluated, plus ongoing phone or internet contact, for a period of two years.

Anyone here been a "subject" in something like this? (My only experience was with Lilly, when they paid students to test shampoos, skin lotions and sunscreen, pretty simple stuff.) What kinds of questions would you ask the intake interviewer?

[Nessus]

Does the question have anything to do with those baby-mangling papers that were touted about the science tabloids again rather recently?

[Dreadnaught]

I assume they cover travel expenses? Any idea what they are looking for? If there's no medication involved, it probably is a lot of routine clinical data collection.

[CitizenCain]

Like any other decision in life - is what you get worth more [to you] than what you're giving up?

You're giving up your time, and, it seems the ability ingest pleasant pharmaceuticals, so you should make sure you get compensated in at least whatever amount that's worth to you.

What other considerations are there?

[Omega]

I'd suggest against it if the drug is still in its embryonic stages of development. There have been several occurrences where the group given the drugs were called back years later and give then, "you might, possibly have a terminal illness because of [insert generic pharmaceutical name]." Honestly, unless the side effects are minimal and the drug is being finalized, I would recommend against it. I'd hate to see you die.

On another note, it's 'Meruka. You're a mature, fully-developed (in all the right places), adult and I'm merely seventeen.

[GGT]

Does the question have anything to do with those baby-mangling papers that were touted about the science tabloids again rather recently?

Baby-mangling papers?

I assume they cover travel expenses? Any idea what they are looking for? If there's no medication involved, it probably is a lot of routine clinical data collection.

I'm told some travel expenses are covered, but that wouldn't be a problem for me. I'm a two hour drive to Philly, and have a sister in the burbs to stay with. I'm there practically every month anyway.

They're looking for alternative ways to treat multi-symptom depressive disorders, since anti-depressants alone aren't always effective (despite the many types and classes, and an explosion of prescribed anti-depressants). Most disorders don't present in isolation anyway, but come coupled with other symptoms and problems. They could be psych-related 'abnormal' or physiologically 'normal-abnormal'.

Examples would be OCD with anxiety that leads to depression over time if untreated (or treated incorrectly). Bipolar disorders that had been well moderated without meds for years, but hit a wall with ageing and/or physical changes (thyroid or adrenal glands). Metabolic or hormonal changes that have depressive components but are often overlooked (low testosterone, menopause, diabetes).

I think it's meant to find a different track than prescribing a secondary "add-on med", like the Abilify and others being pushed in the media now. Sounds like those adjunct meds are gaining popularity for things like ADHD, too BTW. Pretty sure medication or placebos are involved. Not to screen new meds for FDA approval, but "off label use" for meds not usually considered as treatment for depressive disorders. HRT or insulin? I don't really know....

At least I'd get a totally free complete physical, and a differential diagnosis or second opinion from top notch docs!

I haven't been very pleased with my mental health care experiences over the last couple of years, basically punted from GP to internist to psychologist to "medication psychiatrist" to MSW counselor/therapist. That tends to happen with self-pay outpatients like me, since my insurance doesn't cover any of those things. They didn't really care for all the questions I asked, or effort spent finding me affordable generic meds (instead of their routine use of scripts costing $500/month), and there's no follow-up or continuity of care....because there's no third party paying their bills.

*edit---my referral person said the doctor they spoke with chuckled when asked what costs I'd be responsible for. Apparently, almost every other respondent had asked what they would be paid to participate, and once they learned it wasn't a paid study, they hung up the phone. *

The "routine clinical data collection" would be welcomed, actually. There's an interesting family history, including endocrine disorders and neuro pathology in older generations, pre-dating today's fancy high tech diagnostic tools. I'm asking here because....well, I've never known anyone who participated in a clinical trial. Trying to gather my list of questions to ask, things to consider, bases to cover. Suggestions appreciated.

Like any other decision in life - is what you get worth more [to you] than what you're giving up?

You're giving up your time, and, it seems the ability ingest pleasant pharmaceuticals, so you should make sure you get compensated in at least whatever amount that's worth to you.

What other considerations are there?

pfft, all life's decisions are multi-factorial, not simple get/give equations. There are many things to consider. One includes the possibility of something that really "works" for me individually, but can't be continued once the study is over because it didn't work well for enough others. What then?

Another is the possibility that tapering/weaning my current medication will throw me into either another vegetative state that persists for months at a time. Or frequent manic-panic-neurotic periods where everyone around me walks on eggshells, but I've lost the insight to even have a clue. If I'm the control group with placebo only....well, I wouldn't want to put my children through any of that again.

I'd gladly spend some time now, in exchange for saving future time and relationships, that might otherwise be wasted in states of depression and anxiety. Life isn't easily led when it's exhaustively erratic or chaotic, then dormant do-nothing paralysis, with huge shifts between ups and downs. It's heartbreaking as a parent to overhear my kids use language like, "uh oh, she's having a crazy day" or "has she taken her pills yet?" or...."do you think it's okay to leave her alone for the weekend?"

Not sure what kind of pharmaceuticals you're taking, but mine have side effects that are NOT pleasant. They're not feel-good pills, uppers or downers, one for happy day, one for energy, one for mellow mood, yet another for 8 hours of sleep. It doesn't work that way. I wouldn't want to live the rest of my life popping pills like that even if it did work.

[Omega]

Although your mental help might skyrocket to deity-levels, think about the physical problems you'll be plagued by. You could have a cool drug addiction like Dr. House, or your liver might deteriorate beyond a salvageable point. Maybe try to jog, swim, hike, or indulge in other high endorphine-releasing activities. If you do hard drugs that will sort of defeat the purpose, but they are always a safe, viable alternative, haha.

[GGT]

yeah, haha. Look kid, don't push me, or I'll compare you to the 17 yr old nazi in Sound of Music.

[CitizenCain]

pfft, all life's decisions are multi-factorial, not simple get/give equations. There are many things to consider. One includes the possibility of something that really "works" for me individually, but can't be continued once the study is over because it didn't work well for enough others. What then?

Fractions? That's how probabilities are generally handled in quantitative equations. For example, if I go all in on a flush draw (~36% chance of hitting), my "expected value" is .36*(amount of money in the pot)... which is why I try to avoid going all in on flush draws.

The bigger problem is definitely quantifying the "value" of all those intangible benefits and risks.

Not sure what kind of pharmaceuticals you're taking, but mine have side effects that are NOT pleasant. They're not feel-good pills, uppers or downers, one for happy day, one for energy, one for mellow mood, yet another for 8 hours of sleep. It doesn't work that way. I wouldn't want to live the rest of my life popping pills like that even if it did work.

My bad - you hear anti-depressants, you think "happy pills." But if that's the case, it would seem like giving up the... "not happy" (?) pills wouldn't be a significant cost. Or might not be a significant cost, at least.

yeah, haha. Look kid, don't push me, or I'll compare you to the 17 yr old nazi in Sound of Music.

Cut him some slack... it's not like he had a choice of what propaganda he was exposed to in public school. "D.A.R.E. to stay off drugs!!!"

Oh what a tangled web we weave, when force the government to deceive [our kids]!

[Aimless]

Find out what the substances are and get a better idea of long- and short-term side-effects. Decide how long a term you're worried about. Identify the possible rewards that matter to you. Figure out what the effects of discontinuing your current medication may be in the short and intermediate term. You can always drop out of the study if you want to.

[Nessus]

Baby-mangling papers?

Unethical medical research papers from a while back that are still getting quotations, not really relevant to this, sorry. (Research ethics but totally different scenario)

[GGT]

Thanks, minx. This one Figure out what the effects of discontinuing your current medication may be in the short and intermediate term. is the hard part. It's not like my primary physician made the referral, and I'll have to ask if/how he's required to be part of this gig. Whether sending in copies of my chart with a narrative, alerting them if I show up in his office as a basket case, or whatever.

A paradox that should be controlled for, right? Seeking depressive types to participate in a study about sub-optimal treatment for depressive disorders, who have to make the decision to end meds, in order to enter the study? Sounds a bit like asking agoraphobics to meet at the Galleria Mall Food Court at noon, to find ways to treat their agoraphobia.



<PS to Omega: sorry if my bad sarcasm didn't translate over the intarweb, or if Cain's post confused you. It's just not a haha funny thing, that's all. >

[Dreadnaught]

1) Are you on meds that would have to end?

2) Are they going to try a different med?

If the answer to 1 is yes, it seems risky. If the answer to number 2 is yes, it could be interesting.

[GGT]

Yes to both.

I'm not "happy" with the medication "trials" I've already been through. Very long processes with fairly bad continuity and follow-up. I've become one of those patients lost in the medical-psychiatric circular loops.



*First phone interview intake sent me to a second intake interview, which promptly ended with my cordless phone battery dying.

[CitizenCain]

"Discontinuation symptoms" (AKA withdrawal) for most anti-depressants are pretty vicious, particularly if you don't ween down the dosage gradually. I'd pass unless they're offering really good money.

[GGT]

It's not a paid study, Cain. I mentioned that earlier.

Ok so here goes:

I've talked to two people so far, both were very nice [and obviously asking questions from the same list]. They're doing a couple of studies on depression concurrently, so I had to make sure they weren't going to divert me into the herbal supplements study (St. John's Wort, etc.)

[Omega]

Did they describe how potent the concoction is? Or what active ingredients they use? Sounds like a pretty powerful, potentially detrimental drug if it cures such severe manic-depression.

[Lebanese Dragon]

It would just be a cost benefit-analysis, and when it came to the first round of tests, I'd probably opt out unless I was desperate, and needed whatever they were testing to work on me for some health related reason.