Clinical development, registration and off-label-use with regard to psychopharmacotherapy in rehabilitation

The presentation intends to broach the issue of clinical development and formal registration for psychiatric drugs which are also used in rehabilitation medicine. Due to the historical shift from national to European registration procedures in the EU, new compounds for major psychiatric disorders (e.g. Major Depression) are centrally evaluated by the EMEA (European Agency for the Evaluation of Medicinal Products; United States: FDA). Clinical development programs of the pharmaceutical industry follow the CPMP (Committee for Proprietary Medicinal Products) guidelines (Note For Guidance On Clinical Investigation Of Medicinal Products), and refer mainly to syndromal diagnostic criteria of major psychiatric disorders according to ICD and DSM. Furthermore, they refer primarily to the proof of efficacy and safety in acute disease states. Instead, psychopharmacotherapy in the field of rehabilitation is frequently driven by different and more symptomatic indications. Long-term outcomes and other specific aspects of rehabilitation medicine (e.g. work- and driving ability) are important for psychopharmacotherapy in rehabilitation. Thus, there is a need to consider those issues in particular with regard to off-label-use and to generate evidence by non-registration trials in the field of rehabilitation.