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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Schizophrenia, Psychoses

Intervention / Treatment
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* Other: maintained antipsychotic treatment vs. stepwise drug discontinuation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>further maintenance antipsychotic treatment and prodrome-based early intervention | Other: maintained antipsychotic treatment vs. stepwise drug discontinuation<br>* maintained antipsychotic treatment (in low dose) vs. stepwise drug discontinuation; both supplemented by prodrome-based early intervention; 1 year<br>|
| Experimental: 2<br>stepwise drug discontinuation (after 1 year maintenance antipsychotic treatment) and prodrome-based early intervention | Other: maintained antipsychotic treatment vs. stepwise drug discontinuation<br>* maintained antipsychotic treatment (in low dose) vs. stepwise drug discontinuation; both supplemented by prodrome-based early intervention; 1 year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychopathology |  | 1 year | 
| social and cognitive functioning |  | 1 year | 
| side-effects |  | 1 year | 
| drop-out |  | 1 year | 
| quality of life |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, first episode, neuroleptic maintenance treatment, drug discontinuation, prodrome based early intervention