Clinical trial NCT00204061: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Psychoses
Keywords: schizophrenia
psychosis
ultra high risk
prodromal state
early intervention
amisulpride
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: German Research Network On Schizophrenia
name: Sanofi-Synthelabo
name: Department of Psychiatry University of Bonn
name: Heinrich-Heine University, Duesseldorf
name: Ludwig-Maximilians - University of Munich
First posted: 2005-09-20
Enrollment: 124
Sex: ALL
Minimum age (years): 14
Maximum age (years): 36
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: improvement of risk related symptoms
timeFrame: 3, 6, 12, 24 months
Secondary outcomes:
measure: Global functioning
timeFrame: 3, 6, 12, 24 months
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Department of Psychiatry and Psycotherapy University of Cologne
state: North Rhine-Westphalia
Study officials:
affiliation: Department of Psychiatry and Psycotherapy University of Cologne
name: Joachim Klosterkötter, Professor
role: STUDY_CHAIR
References: