Clinical trial NCT00159120: Maintenance Treatment vs. Stepwise Drug Discontinuation in First-Episode Schizophrenia
Official title: Maintenance Treatment vs. Stepwise Drug Discontinuation After One Year of Maintenance Treatment in First-Episode Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Psychoses
Keywords: Schizophrenia
first episode
neuroleptic maintenance treatment
drug discontinuation
prodrome based early intervention
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: After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions prodrome based early intervention take place.

Detailed description: After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions pharmacologic early intervention strategies in case of early sign of relapse will be applied.

Eligibility criteria: Inclusion Criteria:

* Patients after 1 year of maintenance treatment after their first-episode in schizophrenia (according ICD-10 F20)
* Age between 18 and 55
* Informed consent
* One year neuroleptic maintenance treatment
* Reaching stable course

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 at the Heinrich-Heine-University of Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf, Germany
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.
citation: Seemuller F, Schennach R, Mayr A, Musil R, Jager M, Maier W, Klingenberg S, Heuser I, Klosterkotter J, Gastpar M, Schmitt A, Schlosser R, Schneider F, Ohmann C, Lewitzka U, Gaebel W, Moller HJ, Riedel M; German Study Group on First-Episode Schizophrenia. Akathisia and suicidal ideation in first-episode schizophrenia. J Clin Psychopharmacol. 2012 Oct;32(5):694-8. doi: 10.1097/JCP.0b013e3182677958.
citation: Gaebel W, Riesbeck M, Wolwer W, Klimke A, Eickhoff M, von Wilmsdorff M, Lemke M, Heuser I, Maier W, Huff W, Schmitt A, Sauer H, Riedel M, Klingberg S, Kopcke W, Ohmann C, Moller HJ; German Study Group on First-Episode Schizophrenia. Relapse prevention in first-episode schizophrenia--maintenance vs intermittent drug treatment with prodrome-based early intervention: results of a randomized controlled trial within the German Research Network on Schizophrenia. J Clin Psychiatry. 2011 Feb;72(2):205-18. doi: 10.4088/JCP.09m05459yel. Epub 2010 Jun 29.