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Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

Primary Purpose

Schizophrenia, Psychoses

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Supportive management
Amisulpride
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, psychosis, ultra high risk, prodromal state, early intervention, amisulpride

Eligibility Criteria

14 Years - 36 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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).

Sites / Locations

  • Department of Psychiatry and Psycotherapy University of Cologne

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

supportive management

amisulpride

Arm Description

needs-focused, unspecific supportive management

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

Outcomes

Primary Outcome Measures

improvement of risk related symptoms
Decrease of symptom scores; complete remission of risk related symptoms

Secondary Outcome Measures

Global functioning
Increase of Global Assessment of Functioning (GAF) scores

Full Information

First Posted
September 12, 2005
Last Updated
December 23, 2014
Sponsor
University of Cologne
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
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1. Study Identification

Unique Protocol Identification Number
NCT00204061
Brief Title
Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis
Official Title
Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psychoses
Keywords
schizophrenia, psychosis, ultra high risk, prodromal state, early intervention, amisulpride

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
supportive management
Arm Type
Placebo Comparator
Arm Description
needs-focused, unspecific supportive management
Arm Title
amisulpride
Arm Type
Experimental
Arm Description
24 months amisulpride 50 to 800 mg, needs-focused, unspecific supportive management.
Intervention Type
Behavioral
Intervention Name(s)
Supportive management
Other Intervention Name(s)
Clinical Management
Intervention Description
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
Drug
Intervention Name(s)
Amisulpride
Other Intervention Name(s)
Solian
Intervention Description
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.
Primary Outcome Measure Information:
Title
improvement of risk related symptoms
Description
Decrease of symptom scores; complete remission of risk related symptoms
Time Frame
3, 6, 12, 24 months
Secondary Outcome Measure Information:
Title
Global functioning
Description
Increase of Global Assessment of Functioning (GAF) scores
Time Frame
3, 6, 12, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim Klosterkötter, Professor
Organizational Affiliation
Department of Psychiatry and Psycotherapy University of Cologne
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Psychiatry and Psycotherapy University of Cologne
City
Cologne
State/Province
North Rhine-Westphalia
ZIP/Postal Code
50924
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.kompetenznetz-schizophrenie.de
Description
Click here for more information about this study: Early pharmacological and psychological intervention for late prodromal states of psychosis
URL
http://www.fetz.de
Description
Homepage of co-ordinating center

Learn more about this trial

Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

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