Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

Sponsor

University of Cologne (Other)

Overall Status

Completed

CT.gov ID

NCT00204061

Collaborator

German Federal Ministry of Education and Research (Other), German Research Network On Schizophrenia (Other), Sanofi-Synthelabo (Industry), Department of Psychiatry University of Bonn (Other), Heinrich-Heine University, Duesseldorf (Other), Ludwig-Maximilians - University of Munich (Other)

124

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Psychoses	Behavioral: Supportive management Drug: Amisulpride	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

Study Start Date :

Jan 1, 2001

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Jun 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: supportive management needs-focused, unspecific supportive management	Behavioral: Supportive management 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. Other Names: Clinical Management
Experimental: amisulpride 24 months amisulpride 50 to 800 mg, needs-focused, unspecific supportive management.	Drug: Amisulpride 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. Other Names: Solian

Arm

Intervention/Treatment

Placebo Comparator: supportive management

needs-focused, unspecific supportive management

Behavioral: Supportive management

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.

Other Names:

Clinical Management

Experimental: amisulpride

24 months amisulpride 50 to 800 mg, needs-focused, unspecific supportive management.

Drug: Amisulpride

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.

Other Names:

Solian

Outcome Measures

Primary Outcome Measures

improvement of risk related symptoms [3, 6, 12, 24 months]
Decrease of symptom scores; complete remission of risk related symptoms

Secondary Outcome Measures

Global functioning [3, 6, 12, 24 months]
Increase of Global Assessment of Functioning (GAF) scores

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 36 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).