Posted by Racer on October 14, 2007, at 22:25:58
In reply to AZD6765 - Trials - This is upsetting, posted by deniseuk190466 on October 14, 2007, at 16:15:49
While they may have some evidence that the compound will be a good option to treat TRD, they also have to make sure that they are treating depression during the trials. Someone who has failed adequate trials of 5 classes of drugs may have something masquerading as depression -- in which case, they probably won't respond to this one, either.
Most drug trials do exclude a fair number of people. Sometimes they exclude anyone who has any co-occurring disorders, so someone with depression AND anxiety will be excluded, or someone with depression and OCD, or a personality disorder. All of those muddy the water when you're testing a drug to treat depression.
It doesn't seem as though it makes sense, but if they want approval, they have to show that it works. That means giving it to people who are likely to respond to an anti-depressant, even if they're really aiming to treat TRD.
That's my understanding, and simplified some, but i hope it helps.
poster:Racer
thread:789206
URL: http://www.dr-bob.org/babble/20071009/msgs/789308.html