Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204061
Status:
COMPLETED
Last Update Posted:
2014-12-24
First Post:
2005-09-12
Brief Title:
Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis
Sponsor:
University of Cologne
Organization:
University of Cologne
Study Overview
Official Title:
Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None