Guess he showed you Apos.
Tranquilis,
Allow me to start off that I am aware that there are many published meta-analyses documenting the effectiveness of various anti-depressants vs placebo reviewing only double-blind control studies. They work and neuropharmocologists have some very god ideas of how they work.
But.
These same meta-analyses point out several problems. There is a huge variation in the placebo response rate between studies. It is not clear that “major depression” or “severe” or “mild” means the same thing study to study. Some studies which show a positive effect have a less than robust response identified (compared to placebo). While the accusation that docs “prescribe them nearly at random to anyone who steps into their office” is absolutely without foundation, it is true that, despite several generations of DSM, the identification of these conditions and measurement of their severity is still an extremely subjective process, which makes scientific study difficult. Are there any studies which document the reliabilty of the interview/DSM approach? I mean something like, has anyone had a group of patients interviewed on videotape, then shown that tape to a thousand different board-certified psychiatrists, and asked each of them, independently, to give the patients a DSM label? My suspicion is that there would be a fair amount of variabilty, or that “favorite” labels would be used for a variety of patients who could be placed in a variety of classifications … including normal. And since the treatment is perhaps not always much different between anxiety and depression and so on … maybe it doesn’t matter much in any practical sense. But the lack of any proven reproducible measuring instrument, makes serious study hard to interpret.
Now that’s cogent and thoughtful. The short answer, DSeid, is that actually, I rather agree with you, and have similar questions. Truth be told, on the subject of psycoactive drugs, much of the research is, by necesity, quite subjective. This can be combated to a degree by increasing the size and duration of a study, but IRL, three are limits to this approach. The final and ultimate clinical trial comes after approval, when te population at large is exposed to a drug that is only mostly understood.
This is by no fault of the Pharma, nor of the investigator, nor of the FDA (OR EMEA, or MOH, or whomever), but rather of the fact that humans are tremendously variable, often in very subtle ways. Psycoactive drugs are worse than many n this regarde, because they’re using methods of action that are only somewhat understood to combat conditions that are only somewhat understood, and their efficacy can only be determined through subjective interviews. One can simple do a blood count and say 'Aha! You’re less depressed today!"
In general, within one pharma’s studies, you can count on definitions of terms, clinical approaches, and the like to be pretty consistant. This will only become increasingly true as Document Management becomes more efficient. A Clinical Trial Protocol tends to be reused time and again, creating generations of similar descendant protocols, with similar terms, definitions, questionares, and methodologies used in each itteration. This is good in terms of cost savings, efficiency, speed, and consitancy, but may be a troubling if there’s an error or ommission in the protocol. Further, Pharmas don’t share protocols, so definitions, questionares, and methodologies can vary significantly between individual Pharmas.
What’s necessary, IMO, but hasn’t happened, and shows no sign of happening anytime soon, is an industry-wide agreed set of terms, definitions, methodologies, and practices. Well, that, and a lot more basic research.
That’s a lot of work, and may frankly be impossible, but it’s worth a good look.
I was working towards a point, but seem to have lost it somewhere. Oh, well… There’s too much here to delete. 
Gad! That was ugly!
One can’t simply do a blood count and say 'Aha! You’re less depressed today!"
While we’re on the topic of clinical trials and depression, have there been any developments with the implant that stimulates the vagus nerve? A year or two ago, I heard that they were starting clinical trials to see if it could be used to treat depression. I haven’t heard a thing about since then.
Further off the topic- Assuming it does work, is it possible to stimulate the vagus by placing electrodes on the skin rather than under it? I wonder if I can rig up something from old walkmans.
Ahunter3-Please expand and further detail your position. This is definitely the right thread. In past threads, your views on the failings of the mental health system have been well thought out and you seem motivated by a desire to help other mental health consumers (remember way back when, in the days when we were just patients?). So, post away!
I’m not familliar with this one. Sounds interesting, though, and I’d like to see the studies. Lemme see what I can dig up.
IIRC the implant was authorized by the FDA for treatment of epilepsy and some other conditions which produce seizures.
The manufacturer was testing the implant’s effectiveness on depression.
I can’t recall any dates or other details at the moment.
Sorry.
Was it an implanted drug, or was it a medical device? If the former, I may be able to find something. If the latter, I have a sister who’s pretty heavy on medical devices.
The implant stimulated the vagus electrically. I don’t recall any kind of drug being involved. An electrode was placed in the neck. The body of the unit was placed below the collar bone(or should I say clavicle? Will I come off as dumb with collar bone or will I come off as smug with clavicle?)
The results of the second vagus stimulation study should be out any day now: http://www.cyberonics.com/new_indications/depression_study_info.htm
There ya go! I learn something new every day around here!
My second-oldest sister is the bio-medical devices expert in the family (Bio-Medical Device Validation Engineer). I’m one of two pharma types in the family.
Outlook good so far. But of course a larger sample size is needed to get meaningful results.
Which brings me back to-
Can the vagus be stimulated without actually sticking electrodes under the skin? As an aspiring Mad Scientist and Son of Ether (pronounced eh-ther not to be confused with ee-ther), the idea of building an electrical device(possibly with vacuum tubes) to cure my depression holds great appeal.
Well, they’re using transcranial magnetic stimulation for depression. It’d probably work on the vagus nerve as well.
There’s enough information on the web that a sufficiently mad scientist and son of the aether could cobble together a tms unit in the basement and forgo the expense and discomfort of hospital based ECTs and etc.
–That’s probably a bad idea though.
Lots of Links
Oh, it’s definitely a bad idea. I’m just trying to work out the specifics. The chances that I’ll make things worse are quite low.
In a certain percentage of people, placebos will work as well as the actual medication. In the case of anti-depressants, I believe I know why this is. Cognitive Behavior Therapy is a type of therapy completely unconcerned with how or why one is depressed or anxious. It is a method of forcing one to confront falsely held beliefs, such as “I will die if I don’t skip every 3rd tile” or “life sucks and will never get better”, and replace them with rational thoughts. In the process of changing the way one thinks about things, actual changes occur within the brain chemistry. So one can conceivably become less anxious or depressed and actually change the chemistry in the brain that makes one anxious or depressed through training the brain to think differently.
With a placebo, certain individuals are so invested in the belief they are on a medication that will make them less anxious or depressed, that they likely undergo the same brain chemistry changes that would take place through Cognitive Behavior Therapy. So they do, in effect, get the chemical response they would get by taking the medication.
I am a person who has OCD. My daughters have OCD, Tourette Syndrome, and one of them has depression. They were both diagnosed at a young enough age that it is obvious to me these disorders are chemical and not psychological. Both respond well to medication. I used to take Luvox myself, and responded well to it. I stopped taking it to participate in a study. I was offered CBT for 12 weeks, medication free. I had enough success with CBT that I no longer take medication.
My oldest daughter has also now undergone CBT. She is not medication free, but is able to take less. Just like the placebo effect does not work for everyone, CBT cannot help everyone. But one CAN make actual changes in brain chemistry through belief. I do not have the cites, but I have seen pictures of brain scans done on individuals before CBT and after, and there is a measurable difference in the brain activity in the orbital cortex. This same difference can be seen between “normal brains” and OCD brains.