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Clinical Trials/NCT00159120
NCT00159120
Completed
Phase 4

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

Heinrich-Heine University, Duesseldorf1 site in 1 country71 target enrollmentNovember 2001

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Heinrich-Heine University, Duesseldorf
Enrollment
71
Locations
1
Primary Endpoint
relapse rate
Status
Completed
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2001
End Date
June 2006
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Heinrich-Heine University, Duesseldorf

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

Outcomes

Primary Outcomes

relapse rate

Time Frame: 1 year

Secondary Outcomes

  • psychopathology(1 year)
  • social and cognitive functioning(1 year)
  • side-effects(1 year)
  • drop-out(1 year)
  • quality of life(1 year)

Study Sites (1)

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