What does double blind mean? Is there a chance I won’t get the real medication?
Double blind means that neither you nor us will know which form of the medication you are getting, only the coordinator will know. The FDA mandates that the protocol for this study provide the patient with one form of the drug for 12 weeks and then switch to the alternate form for 12 weeks. What that means is that you will receive one form (active or inactive) of the drug for 12 weeks and then you will receive the alternate form for the second 12 weeks. The order in which the medication is distributed is kept under code, and not released until the report forms have been submitted to our office and interpreted. After you’ve completed the 6 month double blind phase, if your results are favorable, you will be provided with the active form of the medication in exchange for the questionnaires and daily records. You may remain on the medication until such time as the FDA approves the medication.
