Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

NCT00204061 | Completed Phase 4

• 1 other identifier: 01 GI 9935 - P 1.1.3
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Psychoses

Keywords

schizophrenia; psychosis; ultra high risk; prodromal state; early intervention; amisulpride

Outcome Measures

Primary Outcomes (1)

• improvement of risk related symptoms

  Decrease of symptom scores; complete remission of risk related symptoms

  3, 6, 12, 24 months

Secondary Outcomes (1)

• Global functioning

  3, 6, 12, 24 months

Study Arms (2)

supportive management

PLACEBO COMPARATOR

needs-focused, unspecific supportive management

Behavioral: Supportive management

amisulpride

EXPERIMENTAL

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

Drug: Amisulpride

Interventions

Supportive management BEHAVIORAL

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.

Also known as: Clinical Management

supportive management

Amisulpride DRUG

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.

Also known as: Solian

amisulpride

Eligibility Criteria

• Age: 14 Years - 36 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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).

Sponsors & Collaborators

• University of Cologne: lead
• German Federal Ministry of Education and Research: collaborator
• German Research Network On Schizophrenia: collaborator
• Sanofi-Synthelabo: collaborator
• Department of Psychiatry University of Bonn: collaborator
• Heinrich-Heine University, Duesseldorf: collaborator
• Ludwig-Maximilians - University of Munich: collaborator

Study Sites (1)

Department of Psychiatry and Psycotherapy University of Cologne

Cologne, North Rhine-Westphalia, 50924, Germany

Location

Related 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

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Prodromal Symptoms

Interventions

Amisulpride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Joachim Klosterkötter, Professor

  Department of Psychiatry and Psycotherapy University of Cologne

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head of the Department of Psychiatry

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2001
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: December 24, 2014

Record last verified: 2014-12

Locations

DE (1)