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

September 12, 2005
September 12, 2005
January 2001
Not Provided
  • improvement of prodromal symptoms (ERIRAOS-Scale, PANSS)
  • social impairment
Same as current
No Changes Posted
  • social functioning (GAF)
  • depression
Same as current
Not Provided
Not Provided
 
Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis
Not Provided

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Psychoses
  • Behavioral: Clinical Management (CM)
  • Drug: Amisulpride
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
130
June 2005
Not Provided

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).
Both
14 Years to 36 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00204061
01 GI 9935 - P 1.1.3
Not Provided
Not Provided
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
Study Chair: Joachim Klosterkötter, Professor Department of Psychiatry and Psycotherapy University of Cologne
University of Cologne
April 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP