Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis
Schizophrenia, Psychoses
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, psychosis, ultra high risk, prodromal state, early intervention, amisulpride
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 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).
Sites / Locations
- Department of Psychiatry and Psycotherapy University of Cologne
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
supportive management
amisulpride
needs-focused, unspecific supportive management
24 months amisulpride 50 to 800 mg, needs-focused, unspecific supportive management.