Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

Phase 4

Completed

• Conditions: Psychoses; Schizophrenia
• Interventions: Behavioral: Supportive management; Drug: Amisulpride

• Registration Number: NCT00204061
• Lead Sponsor: University of Cologne

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.

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-23
• Last Update Posted: 2014-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
supportive management	Supportive management	needs-focused, unspecific supportive management
amisulpride	Amisulpride	24 months amisulpride 50 to 800 mg, needs-focused, unspecific supportive management.

Primary Outcome Measures

Name	Time	Method
improvement of risk related symptoms	3, 6, 12, 24 months	Decrease of symptom scores; complete remission of risk related symptoms

Secondary Outcome Measures

Name	Time	Method
Global functioning	3, 6, 12, 24 months	Increase of Global Assessment of Functioning (GAF) scores

Trial Locations

Locations (1)

Department of Psychiatry and Psycotherapy University of Cologne; 🇩🇪 Cologne, North Rhine-Westphalia, Germany