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ADHD Double Blind Trial??

Has ANYONE had to go through a Double Blind Trial?

Here’s some background:

My ds (8) is in 2nd grade.  At the start of kindergarten I realized that he wasn’t sleeping at night.  I put a deer camera in his room and recorded him for about 2 weeks.  He was moving non stop all night long and sitting up quite a bit…sometimes it looked like he was awake and some he was still sleeping…like sleep walking just never leaving his bed.  We started seeing a pediatric neurologist, had a sleep study done that came back perfect..nothing wrong with him.  Neuro was shocked at the footage we took her.  He was put on imipramine for quite some time until he developed side effects that caused me to pull him from it.  No meds at all during the last quarter of 1st grade and his teacher started reporting behavior issues. Saw our pediatrician, who sent us to an ADHD specialist, results came back “on the fence” so he said to continue working with the neurologist.  She then put ds on gabapentin and did a 2nd sleep study which also came back perfectly normal.  She had no reason or diagnosis other than that I reported he was waking rested even though he was still moving all night long.
 
Fast forward to 2nd grade…1st qtr was good.  2nd quarter his behavior marks weren’t very good. Started getting reports daily from teacher.  Refusing to do work, throwing tantrums in class, disruptive and disrespectful towards classmates and teachers.  Seemed very depressed.  3rd qtr was even worse. We removed the gabapentin.and we saw the neuro again and she had us do a re-eval for ADHD which came back as yes, he qualifies so let’s do this trial.  At this point, I was reaching for ANYTHING AND EVERYTHING to find out what could be causing issues with him…I had to at least rule out ADHD if not to diagnose him.  It was to the point I was looking to pull him from school and homeschool but it was too late in the year I was told, so I sat in his class a few times…just so that the behavior wouldn’t happen and the class could have some uninterrupted learning.

The neuro had us start this DOUBLE BLIND TRIAL.  Meaning, no one except pharmacy would know what week was a real rx and what week was a sugar pill.  and we’d do this for 4 weeks and at the end of each week, we’d report back (the teacher, ds, and myself each had our own report).  One week would be concerta 18mg, One week would be concerta 36mg and 2 weeks would be a placebo.

Week 1…my son LOVED LIFE LOVED HIMSELF and LOVED SCHOOL.  He was such a happy child.  He actually had AWESOME marks from the teacher’s daily behavior plan that we had to start him on before the trial.  The SAME math test that he’s been stuck on since the start of 3rd qtr which WHEN he chose to do the test, he was lucky if he got a 12 out of 50….but on the Week one pill from the study, he got a 46/50 and was so proud and a few days later told me he couldn’t WAIT to take it again because he KNEW he was going to pass it!!  He was even waking rested and movements were less…not a lot less..but enough to make a difference in how he wakes up.

This week was week 2 and we are right back to where we were before starting the trial. He told me he wants to feel like he did when he took the pill before (meaning week 1). 

Now mind you…all the pills look the same…we don’t know what week is what.  This week has gotten progressively worse…so today I skipped and gave him a week 4 pill just to see if there was a difference from the week 2 pill.  (and there is…he’s so happy and co-operative today..good report from school and NO I didn’t tell anyone that I skipped and gave a week 4 pill)

So today I called the neuro and asked to be taken off the trial and told them all of what has been happening.  The assistant told me in a round about way so that “I wouldn’t know” that week 1 was not a medication.  She said she had to word it so that she wasn’t telling me it wasn’t a med but so that I would know.  Then she said that they alternated weeks.  So I asked"so then you are telling me that week 1 wasn’t a med which means week 2 is a med?”  she said yes. 

Now, here’s the kicker…the day after easter…the day after indulging in sugar…he had an awesome day at school.  They are refusing to pull us from the trial.  I argued that it’s not fair to my child to hate his life, himself, school, everything for another whole week.  If the placebo is just a sugar pill…and monday after indulging in sugar was a good day…what is going on??  His appetite is decreased this week..noticeably. 

I asked if there was anyway they made a mistake in writing down what was what week.  She said no, she double checked everything :(

I’m at a complete loss.  I made an appt with our pediatrician for next week to get his input and maybe a point in another direction.  HEEEELLLLLP!!!

Replies

You cannot be forced to participate in a study period.  Did the neurologist give you the OPTION to participate in it or did the neurologist make you feel like you had to participate or really, really should participate, or what?

Posted by BC on Apr 26, 2014 at 4:11am

When this was 1st brought up, the neuro said “we could go ahead and try the adhd medications through a double blind trial if that’s what you want to do”.  At that point, I had no idea there was any other way, I wanted to try and rule out or diagnose adhd and so I agreed to it. 

Today when I spoke to the clinic and told them I wanted to be done etc…they said they “really need me to finish the the week 3 and 4” 

And the more I sit on this the more upset I get because I sat there and told them how depressed he is and hates life and himself, and their actions were “we need you to continue with the trial”.  I’m telling them how bad my son is emotionally (not to mention behaviorally) and they choose to do nothing?!?  No 8 year old should feel the way he feels and say the things he says. 

Obviously there is SOMETHING wrong, it may not be ADHD, but if they have the list of what week was what and they see that our results aren’t jiving…don’t you think when I tell them how he’s feeling and things he’s saying they’d say whoa..something isn’t right…let’s move on??!! 

So frustrated!!

Posted by lovemyfamilyof5 on Apr 26, 2014 at 7:56am

My opinion is that they seem much more interested in their research study than in the well-being of their study participants.  Your particular situation/circumstances are not one in which I would have advised you to participate in this particular study.  There are plenty of other “research subjects” out there who would have no major problems with taking the long, scenic route to get to diagnosis & treatment.

Posted by BC on Apr 26, 2014 at 8:37pm

Here are your rights as a participant in a double blind study. If you are told differently, you need to take what you have learned from the study and see a different doc. Ask that new doc. for the meds your son was on during that week. You should no difficulty getting them.

I actually teach a section on ethics in research in my psychology classes. I also have a degree in research methods. So, I feel very comfortable giving you this information.

In any study, if a treatment results in a therapeutic effect, the researcher has the legal obligation to halt it and place the subject permanently on the effective treatment. The subject is under no obligation to continue participating in the trial. As a parent, you also have the right to withdraw your child from the study at any time. You can then request information about the type of treatment your child received, which resulted in the therapeutic effect. If your neurologist or anyone tells you otherwise, they are violating the law and I would get a lawyer if they make any kind of threat to you for asking to withdraw. Violating these principals can result in the inability to conduct research. It can also result in a loss of funding, which is the lifeblood of any study.

I hope you find this information helpful.
Sue H in PC, Ohio

Posted by SueH on Apr 26, 2014 at 11:09pm

The thing I thought of was this… studies show that going onto a stimulant medication slowly (e.g. starting at the lowest does and moving up) results in a better result in the end for the patient.  My son started with 10mg of Biphentin (it’s a Ritalin cousin) one week, 15mg the next, then 20mg and we stopped at 30mg.  I don’t see a humongous difference myself, but my son is happy again.  He’s 11 and like yours was doing fine up to a point (diagnosed with ADHD two years ago but our Dr said no to drugs), but was slowly unraveling… he was refusing to work in class and had even walked out a couple times!  By Christmas of this year I thought he’d have a mental breakdown.  Seriously.  I fought and got him in to see ADHD specialists downtown, he went on the medication and things have improved!  His teachers say he may not be like everyone else (he still needs plenty of accommodations) but he’s *willing* to work again, and for them, and for him, that’s a huge improvement.

Switching from one drug to another, and at different dosages all within the same month seems irresponsible to me.  Especially when it’s not for your son’s benefit, but for a study’s.  I’d listen to the others here and insist that they tell you what he was on that first week.  If it turns out it was a placebo, still leave the study and go get some help for your son.  We’re seeing a psychiatrist for the ADHD now, and it’s made a world of difference… if only because she works entirely with kids and mostly ADHD kids.

Posted by Rai0414 on Apr 27, 2014 at 2:32am

“In any study, if a treatment results in a therapeutic effect, the researcher has the legal obligation to halt it and place the subject permanently on the effective treatment.”

I haven’t looked up the specific numbers or anything, btw, but researchers are obligated to “halt” a study when the data shows that a certain number of study participants are experiencing a significant therapeutic effect.  Those rules/regulations are put in place primarily for earlier “Phase” testing where it is not yet clear how many people will benefit from a drug and how beneficial that drug (or other therapeutic intervention) will truly be.

As a study of this type commences, once the numbers show there is a clear and significant benefit being derived by those subjects who are being given one regimen whereas the subjects who are being denied that same regimen are not deriving those same benefits, this is when a researcher now has the moral/ethical duty to “halt” the study, unblind all participants, and give those who were denied the regimen which produced a pre-determined significant level of success the opportunity to switch (be given this very beneficial regimen).

Researchers have no obligation to “halt” a study when one subject experiences a great benefit.  Or was there something my pharmacology teacher left out when we were taught how drug studies work?

Posted by BC on Apr 27, 2014 at 5:32am

No child should be put through that. Making a child feel bad about themselves knowingly is unethical in my opinion. Tell them in no uncertain terms you will not put your child through this yo-yo and you are done with the study.

Find another neurologist and seek a second opinion.

I feel like they probably weren’t truthful with you when they told you what the medications were so far, especially if they are pushing you to finish the study. I would think giving you that information at that point would make the data gleaned from your son unreliable.

Keep following your gut.

Penny
ADDconnect Moderator & Mom to Tween Boy with ADHD and LDs

Posted by adhdmomma on Apr 28, 2014 at 4:48pm

Just want to reiterate what Penny said (and add a bit, too).  If the study truly is what it was represented to you as being—“double blind”—then the receptionist was bluffing (making you think she knew the med when she did not).  If the study truly is what it was represented to you as being—“double blind”—but the receptionist DOES know what med (or placebo) he was taking that completely invalidates the study (all data obtained is a sham) and legally/ethically that study needs to be halted. 

There is another possibility though—that it is not a “real” double-blind study at all, but a slightly deceptive way this practice has come up with to aid in their own data collection.  They may be using the term “double-blind” fairly loosely and using that to “test” the accuracy of the observers’ reports (two parents, one teacher, one patient).  The placebo effect is a real phenomenon.  If what the receptionist claimed is true (that he was given a placebo) but ALL the observers reported they saw a clear benefit, the medical provider can then conclude that all parties were experiencing the placebo effect. 

I can make a case for it being set up so that all patients are given placebo on Week 1 and Week 2 because that gives some time for whatever placebo effect might take place at the beginning (Week 1) to wash out.

Regardless of which of the different possibilities is true it needs to be reported to the treating physician and dealt with properly.  They need to be called on the carpet for either conducting a study that is purportedly double-blind but is not or misrepresenting a study to be double-blind when they know it is not, (or the receptionist simply making it appear that she knows something she does not).

(And please let us know how that turns out, the speculation is very intriguing; I’d love to know what’s really going on here).  Regardless, I don’t think your son was a good candidate for any of these various “studies.”

Posted by BC on Apr 28, 2014 at 5:45pm

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