Clinical Trial: Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

Brief Summary: The study will provide an empirical basis for a pharmacological treatment option. An open-label, randomized, multi-centre parallel group design is used. An intensified clinical management (CM), which allows needs-based psychological crisis intervention, is compared to a combination of such a CM and the atypical neuroleptic amisulpride. The central hypothesis is that the combination of a clinical management with an atypical neuroleptic is the superior treatment.

Detailed Summary: The first diagnosis of schizophrenia is preceded by a long lasting period comprising an untreated psychotic and a prodromal state. The duration of untreated psychosis correlates with a significant worsening of several outcome variables and persons fulfilling criteria of a prodromal state are already suffering from prodromal symptoms and from a significant deterioration of social and vocational functioning. However, a sufficient strategy for early intervention is still lacking. The study will provide an empirical basis for a pharmacological treatment option. An open-label, randomized, multi-centre parallel group design is used. An intensified clinical management (CM), which allows needs-based psychological crisis intervention, is compared to a combination of such a CM and the atypical neuroleptic amisulpride. For analysis 130 patients will be recruited within three years, the treatment period is two years.
Sponsor: University of Cologne

Current Primary Outcome: improvement of risk related symptoms [ Time Frame: 3, 6, 12, 24 months ]

Decrease of symptom scores; complete remission of risk related symptoms


Original Primary Outcome:

  • improvement of prodromal symptoms (ERIRAOS-Scale, PANSS)
  • social impairment


Current Secondary Outcome: Global functioning [ Time Frame: 3, 6, 12, 24 months ]

Increase of Global Assessment of Functioning (GAF) scores


Original Secondary Outcome:

  • social functioning (GAF)
  • depression


Information By: University of Cologne

Dates:
Date Received: September 12, 2005
Date Started: January 2001
Date Completion:
Last Updated: December 23, 2014
Last Verified: December 2014