Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

Conditions
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Schizophrenia, Psychoses

Intervention / Treatment
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* Behavioral: Supportive management
* Drug: Amisulpride


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: supportive management<br>needs-focused, unspecific supportive management | Behavioral: Supportive management<br>* The needs-focused intervention could include psychoeducation, crisis intervention, family counselling and assistance with education or work-related difficulties, according to need. Regular psychotherapy was not permitted.<br>* Other names: Clinical Management;|
| Experimental: amisulpride<br>24 months amisulpride 50 to 800 mg, needs-focused, unspecific supportive management. | Drug: Amisulpride<br>* Daily doses could range from 50 to 800 mg, with increments of 50 mg at first step and 100 mg at further steps. As a guideline, it was suggested that the dosage be increased as long as attenuated or brief limited intermittent positive symptoms were present. The interval between such steps should be at least 14 days if brief limited symptoms were absent and the APS score had improved.<br>* Other names: Solian;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of risk related symptoms | Decrease of symptom scores; complete remission of risk related symptoms | 3, 6, 12, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global functioning | Increase of Global Assessment of Functioning (GAF) scores | 3, 6, 12, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, psychosis, ultra high risk, prodromal state, early intervention, amisulpride