Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

This study has been completed.
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 (Responsible Party):
Stephan Ruhrmann, University of Cologne
ClinicalTrials.gov Identifier:
NCT00204061
First received: September 12, 2005
Last updated: December 23, 2014
Last verified: December 2014
  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: Supportive management
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
Official Title: Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • improvement of risk related symptoms [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
    Decrease of symptom scores; complete remission of risk related symptoms


Secondary Outcome Measures:
  • Global functioning [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
    Increase of Global Assessment of Functioning (GAF) scores


Enrollment: 124
Study Start Date: January 2001
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Solian

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 (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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Stephan Ruhrmann, Deputy Head of the Department of Psychiatry, University of Cologne
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: December 23, 2014
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
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on July 07, 2015