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.
Investigators
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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