Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

NCT ID: NCT00204061

Last Updated: 2014-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31
• Study Completion Date: 2005-06-30

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.

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.

Conditions

Schizophrenia; Psychoses

Keywords

schizophrenia; psychosis; ultra high risk; prodromal state; early intervention; amisulpride

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

supportive management

needs-focused, unspecific supportive management

Group Type: PLACEBO_COMPARATOR

Supportive management

Intervention Type: BEHAVIORAL

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.

amisulpride

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

Group Type: EXPERIMENTAL

Amisulpride

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DRUG

Other Intervention Names

Clinical Management; Solian

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).

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

German Research Network On Schizophrenia

NETWORK

Sponsor Role: collaborator

Sanofi-Synthelabo

INDUSTRY

Sponsor Role: collaborator

Department of Psychiatry University of Bonn

OTHER

Sponsor Role: collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: collaborator

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Stephan Ruhrmann

Deputy Head of the Department of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joachim Klosterkötter, Professor

Role: STUDY_CHAIR

Department of Psychiatry and Psycotherapy University of Cologne

Locations

Department of Psychiatry and Psycotherapy University of Cologne

Cologne, North Rhine-Westphalia, Germany

Countries

Germany

Related Links

http://www.kompetenznetz-schizophrenie.de

Click here for more information about this study: Early pharmacological and psychological intervention for late prodromal states of psychosis

http://www.fetz.de

Homepage of co-ordinating center

Other Identifiers

01 GI 9935 - P 1.1.3

Identifier Type: -

Identifier Source: org_study_id