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

Sponsor

Heinrich-Heine University, Duesseldorf (Other)

Overall Status

Completed

CT.gov ID

NCT00159133

Collaborator

German Federal Ministry of Education and Research (Other), German Research Network On Schizophrenia (Other), Janssen-Cilag Ltd. (Industry), University of Bonn (Other), Humboldt-Universität zu Berlin (Other), Ludwig-Maximilians - University of Munich (Other), University of Göttingen (Other), University of Cologne (Other), Mainz University (Other), University Hospital Tuebingen (Other), Universität Duisburg-Essen (Other), University of Mannheim (Other), University of Jena (Other), Martin-Luther-Universität Halle-Wittenberg (Other), RWTH Aachen University (Other), University of Wuerzburg (Other)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Psychoses	Drug: antipsychotics vs. Lorazepam (Drugs)	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2001

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Jun 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Early intervention with benzodiazepines in case of prodromal symptoms of an impending relapse	Drug: antipsychotics vs. Lorazepam (Drugs) Early intervention with low-dose antipsychotics vs. lorazepam (up to 3 mg/day) in case of early warning signs of an impending relapse;
Active Comparator: 2 Early intervention with antipsychotics in case of prodromal symptoms of an impending relapse	Drug: antipsychotics vs. Lorazepam (Drugs) Early intervention with low-dose antipsychotics vs. lorazepam (up to 3 mg/day) in case of early warning signs of an impending relapse;

Arm

Intervention/Treatment

Experimental: 1

Early intervention with benzodiazepines in case of prodromal symptoms of an impending relapse

Drug: antipsychotics vs. Lorazepam (Drugs)

Early intervention with low-dose antipsychotics vs. lorazepam (up to 3 mg/day) in case of early warning signs of an impending relapse;

Active Comparator: 2

Early intervention with antipsychotics in case of prodromal symptoms of an impending relapse

Drug: antipsychotics vs. Lorazepam (Drugs)

Early intervention with low-dose antipsychotics vs. lorazepam (up to 3 mg/day) in case of early warning signs of an impending relapse;

Outcome Measures

Primary Outcome Measures

relapse rate [1 year]

Secondary Outcome Measures

psychopathology [1 year]
social and cognitive functioning [1 year]
side-effects [1 year]
drop-out [1 year]
quality of life [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf	Düsseldorf	North Rhine-Westphalia	Germany	40629

Investigators

Study Chair: Wolfgang Gaebel, Professor, Department of Psychiatry and Psychotherapy, University of Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf