Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cologne
• Collaborators: Department of Psychiatry University of Bonn; German Federal Ministry of Education and Research; German Research Network On Schizophrenia; Heinrich-Heine University, Duesseldorf; Ludwig-Maximilians - University of Munich; Sanofi-Synthelabo
• Treatments: Amisulpride; Sulpiride; Sultopride

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).