View clinical trials related to Schizophrenia, Undifferentiated.
Filter by:In the recent context of deinstitutionalization and longitudinal studies pointing to a large number of positive long-term outcommes for people affected by a psychiatric disorder (schizophrenia, bipolar disorder, eating disorder, severe personality disorder, etc.), the possibility of overcoming the consequences of a psychiatric pathology emerges as a solid fact. Therefore, the existence of this possibility calls for the identification of the determinants underlying of the various outcomes over time of those affected by a severe psychiatric disorder, in particular those likely to underpin the most positive developments. While it is well known from a medical point of view that certain dimensions affect the prognosis of persons affected by a severe psychiatric disorder (such as the persistence of negative symptoms or cognitive disorders in schizophrenic disorders), prognosis from a purely medical perspective (and putting aside the role of the person and his environment) seems to be able to account only for a modest proportion of the prognosis of people affected by a serious psychiatric disorder. It is this fact that has gradually led to the emergence of complementary models capable of enriching the understanding of the determinants of the future of people affected by a severe psychiatric disorder, in particular models inviting to separate "becoming of the person" from the " psychiatric disorder "to take into account the" personal role of the person "in his or her own healing. This perspective is the "recovery" perspective. Recovery process is defined as a personal trajectory which includes the person's experiences and the reactions of his / her environment following the installation of a psychiatric disorder, which can support a mode of release of the status of "psychiatric patient". Recovery thus implies an "approach underpinned by the understanding of the human response to pathology" (Noiseux) and, one might add, of its environment. However, while these studies point to a number of crucial dimensions involved in the recovery of a severe psychiatric disorder, one of the important limitations of these studies is the distance from any psychopathological consideration, thus setting aside the possibility of specific processes of recovery depending of the pathology. The identification of recurrent experiential logics specific to the various psychiatric disorders therefore appears to be an important field of investigation. It would potentially be able to guide the development of new therapeutic devices based on the recovery model.
This study is designed to evaluate whether asenapine, which is approved by the United States Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is generally safe and well tolerated in adolescents with schizophrenia. This is an extension of base study P05896 (NCT01190254), which means participants must have completed participation in the 8-week base study in order to qualify for this extension study P05897. Participants in this extension study will receive open-label asenapine for 26 weeks. Throughout the study, observations will be made on each participant at various times to assess the long-term safety, tolerability and efficacy of the study treatment.
This study is designed to evaluate whether asenapine, which is approved by the United States Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is also effective in adolescents with schizophrenia. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 2.5 mg or 5 mg twice daily [BID]) or placebo for 8 weeks. Throughout the study, observations will be made on each participant at various times to assess the efficacy and safety of the study treatment. The primary objective of the trial is to demonstrate significant superiority of at least one asenapine dose to placebo, as measured by the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at Day 56.