Maintenance Treatment vs. Stepwise Drug Discontinuation in First-Episode Schizophrenia
January 28, 2008 updated by: Heinrich-Heine University, Duesseldorf
Maintenance Treatment vs. Stepwise Drug Discontinuation After One Year of Maintenance Treatment in First-Episode Schizophrenia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
71
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Rhine-Westphalia
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Düsseldorf, North Rhine-Westphalia, Germany, 40629
- German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
further maintenance antipsychotic treatment and prodrome-based early intervention
|
maintained antipsychotic treatment (in low dose) vs. stepwise drug discontinuation; both supplemented by prodrome-based early intervention; 1 year
|
|
Experimental: 2
stepwise drug discontinuation (after 1 year maintenance antipsychotic treatment) and prodrome-based early intervention
|
maintained antipsychotic treatment (in low dose) vs. stepwise drug discontinuation; both supplemented by prodrome-based early intervention; 1 year
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
relapse rate
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
quality of life
Time Frame: 1 year
|
1 year
|
|
psychopathology
Time Frame: 1 year
|
1 year
|
|
social and cognitive functioning
Time Frame: 1 year
|
1 year
|
|
side-effects
Time Frame: 1 year
|
1 year
|
|
drop-out
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Wolfgang Gaebel, Professor, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University of Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2001
Primary Completion (Actual)
June 1, 2006
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
September 7, 2005
First Submitted That Met QC Criteria
September 7, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
January 30, 2008
Last Update Submitted That Met QC Criteria
January 28, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01GI 9932 - P 2.2.2.1 / 2
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