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Maintenance Treatment vs. Stepwise Drug Discontinuation in First-Episode Schizophrenia

Primary Purpose

Schizophrenia, Psychoses

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
maintained antipsychotic treatment vs. stepwise drug discontinuation
Sponsored by
Heinrich-Heine University, Duesseldorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, first episode, neuroleptic maintenance treatment, drug discontinuation, prodrome based early intervention

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

further maintenance antipsychotic treatment and prodrome-based early intervention

stepwise drug discontinuation (after 1 year maintenance antipsychotic treatment) and prodrome-based early intervention

Outcomes

Primary Outcome Measures

relapse rate

Secondary Outcome Measures

psychopathology
social and cognitive functioning
side-effects
drop-out
quality of life

Full Information

First Posted
September 7, 2005
Last Updated
January 28, 2008
Sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
German Federal Ministry of Education and Research, German Research Network On Schizophrenia, Janssen-Cilag Ltd., University of Bonn, Humboldt-Universität zu Berlin, Ludwig-Maximilians - University of Munich, University of Göttingen, University of Cologne, Mainz University, University Hospital Tuebingen, Universität Duisburg-Essen, University of Mannheim, University of Jena, Martin-Luther-Universität Halle-Wittenberg, RWTH Aachen University, University of Wuerzburg
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1. Study Identification

Unique Protocol Identification Number
NCT00159120
Brief Title
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

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
German Federal Ministry of Education and Research, German Research Network On Schizophrenia, Janssen-Cilag Ltd., University of Bonn, Humboldt-Universität zu Berlin, Ludwig-Maximilians - University of Munich, University of Göttingen, University of Cologne, Mainz University, University Hospital Tuebingen, Universität Duisburg-Essen, University of Mannheim, University of Jena, Martin-Luther-Universität Halle-Wittenberg, RWTH Aachen University, University of Wuerzburg

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psychoses
Keywords
Schizophrenia, first episode, neuroleptic maintenance treatment, drug discontinuation, prodrome based early intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
further maintenance antipsychotic treatment and prodrome-based early intervention
Arm Title
2
Arm Type
Experimental
Arm Description
stepwise drug discontinuation (after 1 year maintenance antipsychotic treatment) and prodrome-based early intervention
Intervention Type
Other
Intervention Name(s)
maintained antipsychotic treatment vs. stepwise drug discontinuation
Intervention Description
maintained antipsychotic treatment (in low dose) vs. stepwise drug discontinuation; both supplemented by prodrome-based early intervention; 1 year
Primary Outcome Measure Information:
Title
relapse rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
psychopathology
Time Frame
1 year
Title
social and cognitive functioning
Time Frame
1 year
Title
side-effects
Time Frame
1 year
Title
drop-out
Time Frame
1 year
Title
quality of life
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Gaebel, Professor
Organizational Affiliation
Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University of Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf
City
Düsseldorf
State/Province
North Rhine-Westphalia
ZIP/Postal Code
40629
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
15146342
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.
Results Reference
background
PubMed Identifier
22926606
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.
Results Reference
derived
PubMed Identifier
20673559
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.
Results Reference
derived
Links:
URL
http://www.kompetenznetz-schizophrenie.de
Description
Click here for more information about this study: Pharmacological long-term treatment strategies for relapse prevention in first episode schizophrenia

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Maintenance Treatment vs. Stepwise Drug Discontinuation in First-Episode Schizophrenia

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