Long-term studies of antipsychotic drugs in schizophrenia

Abstract

Studies on long-term efficacy and safety should be a main concern in the evaluation of novel antipsychotics. The present paper is a review of important issues related to the design and performance of such trials. The variability of the natural course of schizophrenia, the variability in treatment response, and the variability of actions of different neuroleptics need to be considered. Long-term studies need to address maintenance of efficacy, prevention of relapse and recurrence, health economics, quality of life and a large number of safety issues in order to get approval for new drug applications and reimbursement on expensive new medicines. Assessment instruments for efficacy, tolerability and safety, need to be supplemented with rating scales for various aspects of psychopathology (positive, negative, deficit symptoms), social and work functioning, drug induced mental side effects, quality of life and accounts of total treatment costs.

A review on schizophrenia and relapse—a quest for user‐friendly psychopharmacotherapy

“…Nevertheless, ‘defining relapse’ is critical as the definition could result in variable relapse rates (as was found to be the case with treatment‐resistant schizophrenia (Suzuki et al ., )) and significantly alter the interpretation of the studies (or relapse rates comparison across the treatments) (Knapp et al ., ). While acknowledging the need to consider a variety of aspects within the illness in the real world (Lewander, ), the field needs to agree upon the definition of relapse in schizophrenia to move forward. In light of the fact that the PANSS has been regarded as a ‘standard’ in clinical trials of schizophrenia (Suzuki, ), its use may be endorsed in research settings.…”

Positiv-und Negativsymptomatik bei chronisch schizophrenen Patienten unter Erhaltungstherapie mit Flupentixol-Decanoat im 12-Monats-Verlauf

“…Der Ausprägungsgrad der Bewegungsstörungen wird zum Untersuchungsende in 97,1 % (n = 33) als allenfalls "minimal" eingestuft ( [28]. Zur Beurteilung der Konstanz möglicher Wirkungen wird allerdings eine Mindestbeobachtungszeit von 6 -12 Monaten vorausgesetzt [35,61].…”

“…In der vorliegenden Untersuchung wird mit einem in Therapiestudien bewährten Testinventar [35] Eine größere Anzahl älterer standardisierter kontrollierter Vergleichsstudien mit den Depotformen anderer Neuroleptika wie Fluphenazin, Haloperidol oder Clopenthixol belegen die zumindest gleichwertige Effektivität von Flupentixol-Decanoat bei der Behandlung schizophrener Psychosen [32]. Besonders im Vergleich mit Fluphenazin-Decanoat zeichneten sich wiederholt Vorteile für Flupentixol-Decanoat in der Beeinflussung von Angst, Depression und Antriebsmangel ab, und zwar bei geringerer Häufigkeit pharmakogener Depressionen [19,27,29,54].…”