Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

University of Cologne1 site in 1 country124 target enrollmentJanuary 2001

ConditionsSchizophrenia Psychoses

InterventionsSupportive management Amisulpride

DrugsAmisulpride

Overview

Phase: Phase 4
Intervention: Supportive management
Conditions: Schizophrenia
Sponsor: University of Cologne
Enrollment: 124
Locations: 1
Primary Endpoint: improvement of risk related symptoms
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2001

End Date

June 2005

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Cologne

Responsible Party

Principal Investigator

Stephan Ruhrmann

Deputy Head of the Department of Psychiatry

University of Cologne

Eligibility Criteria

Inclusion Criteria

•General criteria
•Age between 14 and 36 years
•male or female, in- or outpatients
•written informed consent, for patients below 18 years also signed by parents
•Special criteria (present within the last three months prior to the study)
•Attenuated Positive Symptoms (APS)
•Presence of at least one of the following symptoms: ideas of reference, odd beliefs or magical thinking, unusual perceptual experiences, odd thinking and speech, suspiciousness or paranoid ideation
•Symptoms have to appear several times per week for a period of at least one week
•Brief Limited Intermittent Psychotic Symptoms (BLIPS)
•Duration of episode less than one week, interval between episodes at least one week

Exclusion Criteria

•Diagnostic and Statistical Manual of Mental Disorders (DSM) IV diagnosis of schizophrenia, schizophreniform,schizoaffective, delusional or bipolar disorder, at any time of life.
•DSM-IV diagnosis of brief psychotic episode with a duration of more than one week, at any time time of life, or BLIPS within one week before inclusion.
•DSM-IV diagnosis of delirium, dementia, amnestic and other cognitive disorders, mental retardation, mental disorders due to a general medical condition or mental disturbances due to psychotropic substances.
•Abuse of alcohol or drugs within the last three months prior to the study; exception: cannabis user have to be drug-free during four weeks prior to the study. In case of drug abuse, it has to be determined, whether present prodromal symptoms appeared before any drug abuse; If not, symptoms have to be still present after a drug-free period of 3 months (hallucinogens, amphetamines), or four weeks (cannabis).