Pharmacological long-term treatment strategies in first episode schizophrenia--study design and preliminary results of an ongoing RCT within the German Research Network on Schizophrenia.
In first-episode schizophrenia the advantage of new atypical neuroleptics compared to low-dose haloperidol as well as the indicated duration of neuroleptic maintenance treatment has still to be based on empirical evidence. Accordingly, a multi-center study on the optimization of acute and long-term treatment in first-episode schizophrenia is currently being carried out as part of the German Research Network on Schizophrenia. This paper reports on the design, methods and preliminary results of the two-year randomized double-blind study comparing risperidone and low-dose haloperidol within the framework of psychological interventions. In the second treatment year, relapse rates under continued neuroleptic treatment are compared with those under stepwise drug withdrawal substituting instead prodrome-based early intervention (intermittent treatment). As to the results, by November 2003 142 first episode patients (ICD-10 F20) have been included in the long-term study. One-year relapse rates were very low (3.8 %). On average, symptoms as well as drug side-effects decreased steadily under maintenance treatment. Although compliance on average was high, about 60% of the patients dropped out during the first study year. More pronounced psychopathology, (neurological) side-effects, lower compliance at study entry and absence of psychological treatment seemed to enhance the risk for drop-out. In conclusion, treatment in first episode schizophrenia is effective under both (further on blinded) neuroleptics; however these patients are at high risk for treatment drop-out. This emphasizes the need for a special support program.
Gaebel
Wolfgang
W
Department of Psychiatry and Psychotherapy, Heinrich-Heine-University Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstrasse 2, 40629 Duesseldorf, Germany. wolfgang.gaebel@uni-duesseldorf.de
Möller
Hans-Jürgen
HJ
Buchkremer
Gerd
G
Ohmann
Christian
C
Riesbeck
Mathias
M
Wölwer
Wolfgang
W
Von Wilmsdorff
Martina
M
Bottlender
Ronald
R
Klingberg
Stefan
S
D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004409:Dyskinesia, Drug-Induced / Q000150:complications / Q000453:epidemiology; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D010349:Patient Compliance; D010352:Patient Dropouts; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D012008:Recurrence; D018967:Risperidone / Q000627:therapeutic use; D012559:Schizophrenia / Q000188:drug therapy* / Q000453:epidemiology; D012565:Schizophrenic Psychology; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D018967:Risperidone