This is not a minor concern since many first-line treatments for psychiatric conditions involve alternative indications. Tricyclics were the standard antipanic drugs for many years, but none were ever presented to the FDA and awarded this indication. Clinicians can legally prescribe a drug for alternative indications, but restricted publicity may preclude awareness of its use. Also, insurance companies may not cover the cost of a drug prescribed for unapproved indications. In addition to these issues, there are pertinent, unanswered, clinical questions regarding approved drugs.
Most pharmaceutical trials are short-term, and the optimum maintenance dose is often unaddressed.
In the case of antidepressants, this issue has not been subjected to a comparative, randomized trial since approval of the first antidepressant drugs over 30 years ago. This is a formidable obstacle for clinical practice that is not likely to be resolved within the current system of clinical trials. Refractory cases are also rarely studied. Withdrawal syndromes and their care are similarly neglected. Basic information necessary to exercise sound clinical judgment is often not available.