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

Phase 4

Completed

• Conditions: Schizophrenia; Psychoses
• Interventions: Other: maintained antipsychotic treatment vs. stepwise drug discontinuation

• Registration Number: NCT00159120
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Study Timeline

• Study Start: 2001-11
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-28
• Last Update Posted: 2008-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	maintained antipsychotic treatment vs. stepwise drug discontinuation	further maintenance antipsychotic treatment and prodrome-based early intervention
2	maintained antipsychotic treatment vs. stepwise drug discontinuation	stepwise drug discontinuation (after 1 year maintenance antipsychotic treatment) and prodrome-based early intervention

Primary Outcome Measures

Name	Time	Method
relapse rate	1 year

Secondary Outcome Measures

Name	Time	Method
psychopathology	1 year
social and cognitive functioning	1 year
side-effects	1 year
drop-out	1 year
quality of life	1 year

Trial Locations

Locations (1)

German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf; 🇩🇪 Düsseldorf, North Rhine-Westphalia, Germany