Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

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.

Conditions

• Schizophrenia
• Psychoses

Interventions

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.

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.

Sponsors & Collaborators

• German Federal Ministry of Education and Research

  collaborator OTHER_GOV

• German Research Network On Schizophrenia

  collaborator NETWORK

• Sanofi-Synthelabo

  collaborator INDUSTRY

• Department of Psychiatry University of Bonn

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• University of Cologne

  lead OTHER

Principal Investigators

• Joachim Klosterkötter, Professor · Department of Psychiatry and Psycotherapy University of Cologne

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

36 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-01-31

Primary Completion

2005-06-30

Completion

2005-06-30

Countries

• Germany

Study Locations