Status:
COMPLETED
Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis
Lead Sponsor:
University of Cologne
Collaborating Sponsors:
German Federal Ministry of Education and Research
German Research Network On Schizophrenia
Conditions:
Schizophrenia
Psychoses
Eligibility:
All Genders
14-36 years
Phase:
PHASE4
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 ...
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 wor...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00204061
Start Date
January 1 2001
End Date
June 1 2005
Last Update
December 24 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Psychiatry and Psycotherapy University of Cologne
Cologne, North Rhine-Westphalia, Germany, 50924