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

• Sponsor: Heinrich-Heine University, Duesseldorf (Other)
• Overall Status: Completed
• CT.gov ID: NCT00159120
• Collaborator: German Federal Ministry of Education and Research (Other), German Research Network On Schizophrenia (Other), Janssen-Cilag Ltd. (Industry), University of Bonn (Other), Humboldt-Universität zu Berlin (Other), Ludwig-Maximilians - University of Munich (Other), University of Göttingen (Other), University of Cologne (Other), Mainz University (Other), University Hospital Tuebingen (Other), Universität Duisburg-Essen (Other), University of Mannheim (Other), University of Jena (Other), Martin-Luther-Universität Halle-Wittenberg (Other), RWTH Aachen University (Other), University of Wuerzburg (Other)
• Enrollment: 71
• Location: 1
• Arms: 2
• Duration (Months): 55
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Psychoses	Other: maintained antipsychotic treatment vs. stepwise drug discontinuation	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Maintenance Treatment vs. Stepwise Drug Discontinuation After One Year of Maintenance Treatment in First-Episode Schizophrenia
• Study Start Date: Nov 1, 2001
• Actual Primary Completion Date: Jun 1, 2006
• Actual Study Completion Date: Jun 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 further maintenance antipsychotic treatment and prodrome-based early intervention	Other: maintained antipsychotic treatment vs. stepwise drug discontinuation; 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	Other: maintained antipsychotic treatment vs. stepwise drug discontinuation; maintained antipsychotic treatment (in low dose) vs. stepwise drug discontinuation; both supplemented by prodrome-based early intervention; 1 year

Outcome Measures

Primary Outcome Measures

1. relapse rate [1 year]

Secondary Outcome Measures

1. psychopathology [1 year]

2. social and cognitive functioning [1 year]

3. side-effects [1 year]

4. drop-out [1 year]

5. quality of life [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf	Düsseldorf	North Rhine-Westphalia	Germany	40629

Sponsors and Collaborators

• Heinrich-Heine University, Duesseldorf
• 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

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here for more information about this study: Pharmacological long-term treatment strategies for relapse prevention in first episode schizophrenia

Publications

• Gaebel W, Möller HJ, Buchkremer G, Ohmann C, Riesbeck M, Wölwer 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.

• ClinicalTrials.gov Identifier: NCT00159120
• Other Study ID Numbers: 01GI 9932 - P 2.2.2.1 / 2
• First Posted: Sep 12, 2005
• Last Update Posted: Jan 30, 2008
• Last Verified: Jan 1, 2008

• Keywords provided by , ,: Schizophrenia; first episode; neuroleptic maintenance treatment; drug discontinuation; prodrome based early intervention
• Additional relevant MeSH terms: Schizophrenia; Antipsychotic Agents

Study Results

No Results Posted as of Jan 30, 2008