Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis
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.
Behavioral: Supportive management
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis|
- improvement of risk related symptoms [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]Decrease of symptom scores; complete remission of risk related symptoms
- Global functioning [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]Increase of Global Assessment of Functioning (GAF) scores
|Study Start Date:||January 2001|
|Study Completion Date:||June 2005|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
Placebo Comparator: supportive management
needs-focused, unspecific supportive management
Behavioral: Supportive management
The needs-focused intervention could include psychoeducation, crisis intervention, family counselling and assistance with education or work-related difficulties, according to need. Regular psychotherapy was not permitted.
Other Name: Clinical Management
24 months amisulpride 50 to 800 mg, needs-focused, unspecific supportive management.
Daily doses could range from 50 to 800 mg, with increments of 50 mg at first step and 100 mg at further steps. As a guideline, it was suggested that the dosage be increased as long as attenuated or brief limited intermittent positive symptoms were present. The interval between such steps should be at least 14 days if brief limited symptoms were absent and the APS score had improved.
Other Name: Solian
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204061
|Department of Psychiatry and Psycotherapy University of Cologne|
|Cologne, North Rhine-Westphalia, Germany, 50924|
|Study Chair:||Joachim Klosterkötter, Professor||Department of Psychiatry and Psycotherapy University of Cologne|