Prodrome-Based Early Intervention With Antipsychotics vs. Benzodiazepines in First-Episode Schizophrenia

Study Overview
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Brief Summary
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Prodrome based early intervention with an antipsychotic drug vs. benzodiazepine was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. Two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment, the other one after stepwise drug discontinuation.

Detailed Description
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In case of early signs of a relapse prodrome based early intervention with an antipsychotic drug (Haloperidol, Risperidone and other) vs. benzodiazepine (Lorazepam) was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. Two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment (Haloperidol, Risperidone and other) , the other one after stepwise drug discontinuation.

Official Title
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Prodrome-Based Early Intervention With Antipsychotics vs. Benzodiazepine in Patients With First-Episode Schizophrenia After One Year Maintenance Treatment Under Further Maintenance Treatment vs. Stepwise Discontinued Drugs

Conditions
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Schizophrenia, Psychoses

Intervention / Treatment
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* Drug: antipsychotics vs. Lorazepam (Drugs)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First-episode in schizophrenia (according ICD-10 F20) Age between 18 and 55 Informed consent One year neuroleptic maintenance treatment 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Early intervention with benzodiazepines in case of prodromal symptoms of an impending relapse | Drug: antipsychotics vs. Lorazepam (Drugs)<br>* Early intervention with low-dose antipsychotics vs. lorazepam (up to 3 mg/day) in case of early warning signs of an impending relapse;<br>|
| Active Comparator: 2<br>Early intervention with antipsychotics in case of prodromal symptoms of an impending relapse | Drug: antipsychotics vs. Lorazepam (Drugs)<br>* Early intervention with low-dose antipsychotics vs. lorazepam (up to 3 mg/day) in case of early warning signs of an impending relapse;<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, prodrome based early intervention, antipsychotics - benzodiazepine, maintenance treatment, drug discontinuation