ABSTRACT
A double-blind multicentre study comparing the efficacy and safety of remoxipride in controlled-release formulation (REM-CR), given once a day, and immediate-release formulation (REM-IR) and haloperidol, given twice daily, was conducted in patients with schizophrenic illness. In total, 150 inpatients were randomized: 49, 51 and 50 in the REM-CR, REM-IR, and haloperidol groups, respectively. The mean daily dose of REM-CR during the last week of treatment was 361 mg, that of REM-IR 332 mg. In the haloperidol group the corresponding dose was 12.5mg per day. The study treatment period was four weeks. The median BPRS total score was 37.5 in the REM-CR group at start of treatment, and 14.5 at last rating (n = 38). For the REM-IR group and the haloperidol group the corresponding figures were 36.0 and 38.0 at start of treatment and 18.0 (n = 43) and 16.5 (n = 40) at last rating. No statistically significant differences were found between the treatments. Therapy-emergent extrapyramidal symptoms (Simpson & Angus rating scale) were significantly (p less than 0.05) more frequent and more severe during haloperidol than during REM-CR and REM-IR treatment, despite significantly higher concurrent use of anticholinergic drugs in the haloperidol group.--REM-CR was comparable in efficacy and tolerability to REM-IR. The tolerability profile favoured both remoxipride formulations over haloperidol. Evaluation of the clinical chemistry, haematology, and cardiovascular data showed no clinically significant deleterious effects on any organ system for either drug.
Subject(s)
Antipsychotic Agents/therapeutic use , Benzamides/therapeutic use , Haloperidol/therapeutic use , Schizophrenia/drug therapy , Adolescent , Adult , Antipsychotic Agents/administration & dosage , Antipsychotic Agents/adverse effects , Basal Ganglia Diseases/physiopathology , Benzamides/administration & dosage , Benzamides/adverse effects , Delayed-Action Preparations , Double-Blind Method , Female , Haloperidol/adverse effects , Humans , Male , Middle Aged , Psychiatric Status Rating Scales , RemoxiprideABSTRACT
A double-blind multicentre study was undertaken to compare the efficacy and safety of remoxipride in a controlled release (CR) formulation given once daily with haloperidol twice daily in patients with schizophrenic illness. In total, 114 patients were included. All were diagnosed as schizophrenic or schizophreniform according to DSM-III. Their mean daily dose of remoxipride CR during the last week of treatment was 385 mg. In the haloperidol group the corresponding dose was 17 mg per day. The intended study period was 4 weeks with at least a one-day washout. No significant differences were found between treatments regarding efficacy variables. The median total Brief Psychiatric Rating Scale (BPRS) score was 40 in the remoxipride CR group at start of treatment and 21 at last valid rating. For the haloperidol group the corresponding figures were 40 and 22. Treatment-emergent extrapyramidal symptoms (Simpson and Angus rating) occurred statistically significantly more frequently and were more severe during haloperidol than during remoxipride CR treatment despite a statistically significantly higher concurrent use of anticholinergic drugs in the haloperidol group.
Subject(s)
Antipsychotic Agents/administration & dosage , Benzamides/administration & dosage , Haloperidol/administration & dosage , Psychotic Disorders/drug therapy , Schizophrenia/drug therapy , Schizophrenic Psychology , Acute Disease , Adolescent , Adult , Aged , Antipsychotic Agents/adverse effects , Basal Ganglia Diseases/etiology , Benzamides/adverse effects , Delayed-Action Preparations , Dose-Response Relationship, Drug , Double-Blind Method , Drug Administration Schedule , Female , Haloperidol/adverse effects , Humans , Male , Middle Aged , Psychiatric Status Rating Scales , RemoxiprideABSTRACT
The clinical stages of alcoholic delirium include: autonomic-motor excitation; epileptic attacks; psychopathological symptoms; and terminal sleep. The course of these symptoms, their relationship to one another and their severity are discussed.