Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

Schizophrenia Clinical Trial

Official title:

Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204061
• Other study ID #: 01 GI 9935 - P 1.1.3
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: December 23, 2014
• Start date: January 2001
• Est. completion date: June 2005

Study information

• Verified date: December 2014
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 36 Years

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychoses
• Psychotic Disorders
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psycotherapy University of Cologne	Cologne	North Rhine-Westphalia

Sponsors (7)

Lead Sponsor	Collaborator
University of Cologne	Department of Psychiatry University of Bonn, German Federal Ministry of Education and Research, German Research Network On Schizophrenia, Heinrich-Heine University, Duesseldorf, Ludwig-Maximilians - University of Munich, Sanofi-Synthelabo

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of risk related symptoms	Decrease of symptom scores; complete remission of risk related symptoms	3, 6, 12, 24 months	No
Secondary	Global functioning	Increase of Global Assessment of Functioning (GAF) scores	3, 6, 12, 24 months	No

External Links

•   Click here for more information about this study: Early pharmacological and psychological intervention for late prodromal states of psychosis
•   Homepage of co-ordinating center