Clinical trial NCT00159133: Prodrome-Based Early Intervention With Antipsychotics vs. Benzodiazepines in First-Episode Schizophrenia
Official title: Prodrome-Based Early Intervention With Antipsychotics vs. Benzodiazepine in Patients With First-Episode Schizophrenia After One Year Maintenance Treatment Under Further Maintenance Treatment vs. Stepwise Discontinued Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Psychoses
Keywords: Schizophrenia
first episode
prodrome based early intervention
antipsychotics - benzodiazepine
maintenance treatment
drug discontinuation
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: German Research Network On Schizophrenia
name: Janssen-Cilag Ltd.
name: University of Bonn
name: Humboldt-Universität zu Berlin
name: Ludwig-Maximilians - University of Munich
name: University of Göttingen
name: University of Cologne
name: Mainz University
name: University Hospital Tuebingen
name: Universität Duisburg-Essen
name: University of Mannheim
name: University of Jena
name: Martin-Luther-Universität Halle-Wittenberg
name: RWTH Aachen University
name: University of Wuerzburg
First posted: 2005-09-12
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prodrome based early intervention with an antipsychotic drug vs. benzodiazepine was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. Two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment, the other one after stepwise drug discontinuation.

Detailed description: In case of early signs of a relapse prodrome based early intervention with an antipsychotic drug (Haloperidol, Risperidone and other) vs. benzodiazepine (Lorazepam) was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. Two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment (Haloperidol, Risperidone and other) , the other one after stepwise drug discontinuation.

Eligibility criteria: Inclusion Criteria:

* First-episode in schizophrenia (according ICD-10 F20)
* Age between 18 and 55
* Informed consent
* One year neuroleptic maintenance treatment

Exclusion Criteria:

* Residence outside of the catchment area
* Legal reasons
* Insufficient knowledge of the german language
* Substance abuse or addiction
* Pregnancy
* Serious physical illness
* Organic brain disease
* Contraindication to neuroleptic treatment

Primary outcomes:
measure: relapse rate
timeFrame: 1 year
Secondary outcomes:
measure: psychopathology
timeFrame: 1 year
measure: social and cognitive functioning
timeFrame: 1 year
measure: side-effects
timeFrame: 1 year
measure: drop-out
timeFrame: 1 year
measure: quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf
state: North Rhine-Westphalia
Study officials:
affiliation: Department of Psychiatry and Psychotherapy, University of Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf
name: Wolfgang Gaebel, Professor
role: STUDY_CHAIR
References:
citation: Gaebel W, Moller HJ, Buchkremer G, Ohmann C, Riesbeck M, Wolwer W, Von Wilmsdorff M, Bottlender R, Klingberg S. Pharmacological long-term treatment strategies in first episode schizophrenia--study design and preliminary results of an ongoing RCT within the German Research Network on Schizophrenia. Eur Arch Psychiatry Clin Neurosci. 2004 Apr;254(2):129-40. doi: 10.1007/s00406-004-0509-y.