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Question
Posted by: Talulah | 2010-09-10

Childhood depression studies

Hi CS in our community paper yesterday I saw the kidswithdepression site advertising that parents of depressed young kids (6-11) come forward and take part in a clinical study. My little girl is struggling with a lot of late and is acting out on various levels. I do want her to get assistance but I can''t afford it privately - is it safe to participate in clinical trails? The children will be on placebos for 10 weeks and for 7 weeks thereafter, on this trial drug/s.

As a parent, what should I do to have peace in my heart that the drug trials are safe? They are being conducted simultaneously across the world, at five or six key sites I think, one of which is South Africa.

How does one decide on the safety of drug trials? Which pharmaceutical company is testing the drug is not mentioned on the site.

Also, could u advise how one generally gets to hear about clinical trials? How are these made known to the public? This is the first one I have ever seen in the media.

thanks

Talulah

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Our expert says:
Expert ImageCyberShrink

I wish there was a general answer to this question. Generally, one should be safe taking part in a PROPERLY designed and conducted clinical trial - if it has been considered and passed by the Ethics committee of a major university medical school, which should have looked into all possible risks and benefits. And special consideration should have been given when the trial is to be involving children.
Generally, earlier trials with animals and well human voluneeers, should have already proved that the m edication is safe and potentially effective, before the authorities would approve moving on to broader trials in patients, that is, people with a disorder.
From time to time I see ads in the media about such trials. I think they should mention at least which drug company is sponsoring it. Inquire further - in a trial involving children, they should provide the parents with a details print-out pamphlet about the drug, what is already known about it, the risks and benefits, exactly how the trial will be condicted, and it should specify that the company will be responsible for any and all expenses, not only those that are a routine part of the trial, but if the child gets sick or needs further treatment.
Usually, too, is the person responds well to the drug, there will be an agreement that the company will continue to supply the drug free of charge for as long as the patient requires it. If this was not so, there'd be the sad situation o someone doing well on a medicine they coul;dn't otherwise afford, who ould have to stop taking it and perhaps relapse.
The design described, starting with 10 weeks on placebo and then on the drug, sounds a bit odd. The point of using a placebo ( an inactive pill that looks like the drug ) is to have a trial where at random, some of the kids would be taking the drug and some the placebo, and then halfway through, they'd be swopped over, so those on placebo would not receive the drug, and vice versa. This way the doctors and nurses dealing with the patient shouldn't know which the person is receiving, so their rating of the effectiveness won't be biased by their expectations, and with the swap-over, everyone will at some time receive both the active drug and the placebo. At the end, a proper analysis of the results will show whether the drug was significantly more helpful than the placebo.
Anyhoe if you contact them and express an interest in taking part, they should meet with you and perhaps your child, to discuss all this with you, and to help you make a final decision about it.

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Our users say:
Posted by: cybershrink | 2010-09-10

I wish there was a general answer to this question. Generally, one should be safe taking part in a PROPERLY designed and conducted clinical trial - if it has been considered and passed by the Ethics committee of a major university medical school, which should have looked into all possible risks and benefits. And special consideration should have been given when the trial is to be involving children.
Generally, earlier trials with animals and well human voluneeers, should have already proved that the m edication is safe and potentially effective, before the authorities would approve moving on to broader trials in patients, that is, people with a disorder.
From time to time I see ads in the media about such trials. I think they should mention at least which drug company is sponsoring it. Inquire further - in a trial involving children, they should provide the parents with a details print-out pamphlet about the drug, what is already known about it, the risks and benefits, exactly how the trial will be condicted, and it should specify that the company will be responsible for any and all expenses, not only those that are a routine part of the trial, but if the child gets sick or needs further treatment.
Usually, too, is the person responds well to the drug, there will be an agreement that the company will continue to supply the drug free of charge for as long as the patient requires it. If this was not so, there'd be the sad situation o someone doing well on a medicine they coul;dn't otherwise afford, who ould have to stop taking it and perhaps relapse.
The design described, starting with 10 weeks on placebo and then on the drug, sounds a bit odd. The point of using a placebo ( an inactive pill that looks like the drug ) is to have a trial where at random, some of the kids would be taking the drug and some the placebo, and then halfway through, they'd be swopped over, so those on placebo would not receive the drug, and vice versa. This way the doctors and nurses dealing with the patient shouldn't know which the person is receiving, so their rating of the effectiveness won't be biased by their expectations, and with the swap-over, everyone will at some time receive both the active drug and the placebo. At the end, a proper analysis of the results will show whether the drug was significantly more helpful than the placebo.
Anyhoe if you contact them and express an interest in taking part, they should meet with you and perhaps your child, to discuss all this with you, and to help you make a final decision about it.

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