early pharmacological and psychological intervention for late prodromal states of psychosis

Conditions: Schizophrenia; Psychoses

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.

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.

Eligibility criteria:
inclusion criteria: 1. 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 2. 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 and / or * brief limited intermittent psychotic symptoms (blips) * duration of episode less than one week, interval between episodes at least one week * symptoms resolve spontaneously * presence of at least one of the following symptoms: hallucinations, delusions, formal thought disorder, gross disorganized or catatonic behavior 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).

Keywords: schizophrenia psychosis ultra high risk prodromal state early intervention amisulpride