Fluperlapine in 104 schizophrenic patients. Open multicenter trial

Twelve parallel, open, uncontrolled therapeutic studies on 3-fluoro-6-(4-methyl-piperazinyl)- 11H -dibenz[b,e]azepine ( fluperlapine , NB-106 689) were performed as a multicenter trial using standardized protocol/case report forms and inclusion and global assessment criteria. 66% of 104 medium to severe acute or relapsed schizophrenic patients showed a very good or good overall benefit (responder rate 80%) with 200-400 mg fluperlapine daily, median 300; 20-1200 mg; 6 weeks. Ratings ( FSCL -NL = (Fischer Symptom Check List Neuroleptics, BPRS = Brief Psychiatric Rating Scale, FSUCL = Fischer Somatic Symptoms and Untoward Effects Check List) showed a quick onset of action (25% improvement in 5 days) and a very good improvement of all important and secondary single symptoms or symptom groups. FSCL -NL and BPRS were highly correlated (R = 0.87). Tolerability was very good or good in 88% of patients (very good in 65%, poor or bad in 12%), mild to moderate fatigue being the most prominent untoward effect (means 25% of patients, max. 31 per control) followed by dizziness, tremor, dry mouth (10%). No drug-induced Parkinsonism was seen. No recurrent or relevant abnormalities in relation to fluperlapine were observed in safety data (circulation, blood, kidney or liver function). Several times paroxysmal dysrhythmias/sharp waves were seen in the EEG, and in our studies 2 patients experienced epileptiform seizures of short duration after overdosage. In one patient showing a granulocytopenia before starting fluperlapine , an agranulocytosis was seen, which normalized quickly after stopping fluperlapine .