Effects of supidimide in schizophrenic inpatients undergoing neuroleptic maintenance therapy with haloperidol.
Forty schizophrenic inpatients, on constant low-dosage maintenance therapy with haloperidol, entered a superimposed, double-blind, placebo-controlled clinical trial with supidimide 2 x 200 mg per day. The double-blind phase lasted 5 days and was preceded and followed by single-blind base line and washout periods, respectively, during which all patients received matching placebos. The therapeutic effects were evaluated by BPRS, NOSIE, a post-sleep questionnaire, and, in a subgroup of patients, by objective monitoring of movements during sleep. Supidimide substantially relieved sleep disturbances, as demonstrated by subjective (p less than 0.05; n = 20) and objective (p less than 0.1; n = 3) measurements. In addition, the following drug-related effects (p less than 0.05 versus base line and placebo) on daytime behaviour were observed: a decrease in "somatic concern" (BPRS), items related to agitation (BPRS), "irritability" and "manifest psychosis" (NOSIE), and a slight increase in "retardation" (NOSIE). No adverse effects attributable to supidimide were detected. It is concluded that supidimide exerts beneficial effects on day-time behaviour and sleep in agitated schizophrenic patients undergoing low-dosage maintenance neuroleptic therapy.
D000328:Adult; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D006220:Haloperidol / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D011569:Psychiatric Status Rating Scales; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D012890:Sleep / Q000187:drug effects; D013792:Thalidomide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013997:Time Factors
D013792:Thalidomide; D006220:Haloperidol; C027948:supidimide