Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 1999 by University of Cologne.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
German Research Network On Schizophrenia
Sanofi-Synthelabo
Department of Psychiatry University of Bonn
Heinrich-Heine University, Duesseldorf
Ludwig-Maximilians - University of Munich
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00204061
First received: September 12, 2005
Last updated: NA
Last verified: April 1999
History: No changes posted
  Purpose

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 Intervention Phase
Schizophrenia
Psychoses
Behavioral: Clinical Management (CM)
Drug: Amisulpride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • improvement of prodromal symptoms (ERIRAOS-Scale, PANSS)
  • social impairment

Secondary Outcome Measures:
  • social functioning (GAF)
  • depression

Estimated Enrollment: 130
Study Start Date: January 2001
Estimated Study Completion Date: June 2005
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.

  Eligibility

Ages Eligible for Study:   14 Years to 36 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
    • Presence of at least one of the following symptoms (assessed by ERIraos):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 (assessed by ERIraos): Hallucinations, Delusions, Formal thought disorder, Gross disorganized or catatonic behavior

Exclusion Criteria:

  • 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 psy-chotropic 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204061

Locations
Germany
Department of Psychiatry and Psycotherapy University of Cologne
Cologne, North Rhine-Westphalia, Germany, 50924
Sponsors and Collaborators
University of Cologne
German Federal Ministry of Education and Research
German Research Network On Schizophrenia
Sanofi-Synthelabo
Department of Psychiatry University of Bonn
Heinrich-Heine University, Duesseldorf
Ludwig-Maximilians - University of Munich
Investigators
Study Chair: Joachim Klosterkötter, Professor Department of Psychiatry and Psycotherapy University of Cologne
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00204061     History of Changes
Other Study ID Numbers: 01 GI 9935 - P 1.1.3
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
schizophrenia
psychosis
ultra high risk
prodromal state
early intervention
amisulpride

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Sultopride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014