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

Schizophrenia Clinical Trial

Official title:

Maintenance Treatment vs. Stepwise Drug Discontinuation After One Year of Maintenance Treatment in First-Episode Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00159120
• Other study ID #: 01GI 9932 - P 2.2.2.1 / 2
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: January 28, 2008
• Start date: November 2001
• Est. completion date: June 2006

Study information

• Verified date: January 2008
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychoses
• Schizophrenia

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

Locations

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

Sponsors (17)

Lead Sponsor

Collaborator

Heinrich-Heine University, Duesseldorf

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

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relapse rate		1 year	No
Secondary	psychopathology		1 year	No
Secondary	social and cognitive functioning		1 year	No
Secondary	side-effects		1 year	Yes
Secondary	drop-out		1 year	No
Secondary	quality of life		1 year	No

External Links

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