title: Efficacy and safety of the sigma receptor ligand EMD 57445 (panamesine) in patients with schizophrenia: an open clinical trial.
abstract: EMD 57455 (panamesine) is a new sigma receptor ligand alleged to have antipsychotic effects. Animal studies have demonstrated that EMD 57445 has a functional antidopaminergic activity without extrapyramidal side effects and a c-fos expression pattern similar to that obtained with atypical neuroleptics. Therefore, the substance might be of interest for the treatment of schizophrenia. The present article describes the results of an exploratory open clinical trial that was aimed at determining the appropriate dose range for clinical efficacy and safety of EMD 57455 in patients with an acute episode of schizophrenia. In a treatment period of 4 weeks, 12 patients received EMD 57445 up to 60 mg/day for 4 weeks. Seven patients completed the study: four were classified as responders (as defined by at least a 50% decrease in the BPRS total score), two improved slightly and one patient remained unimproved. The intent-to-treat analysis showed significant improvement in the psychometric variables assessed by the Brief Psychiatric Rating Scale, Clinical Global Impression and Positive and Negative Symptoms Scale. Major side effects were extrapyramidal symptoms in two patients and restlessness in one patient. With respect to efficacy and safety, our data agree with a previous study, except that in our study EMD 57455 was not totally free of extrapyramidal side effects.
authors.affiliation: Department of Psychiatry and Psychotherapy, University of Marburg, Germany. huberm@mailer.uni-marburg.de
authors.forename: M T
authors.initials: MT
authors.lastname: Huber
authors.forename: U
authors.initials: U
authors.lastname: Gotthardt
authors.forename: W
authors.initials: W
authors.lastname: Schreiber
authors.forename: J C
authors.initials: JC
authors.lastname: Krieg
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008024:Ligands; D008297:Male; D008875:Middle Aged; D010080:Oxazoles / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D010880:Piperidines / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D017480:Receptors, sigma / Q000502:physiology*; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology
chemical_list: D014150:Antipsychotic Agents; D008024:Ligands; D010080:Oxazoles; D010880:Piperidines; D017480:Receptors, sigma; C103849:panamesine