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

This study has been completed.

First Received: September 7, 2005 Last Updated: January 28, 2008 History of Changes

Sponsor:	Heinrich-Heine University, Duesseldorf
Collaborators:	German Federal Ministry of Education and Research German Research Network On Schizophrenia Janssen-Cilag Ltd. University Hospital, Bonn Humboldt-Universität zu Berlin Ludwig-Maximilians - University of Munich University of Göttingen University of Cologne Mainz University University Hospital Tuebingen Univeristat Duisburg-Essen University of Mannheim University of Jena Martin-Luther-Universität Halle-Wittenberg RWTH Aachen University University of Wuerzburg
Information provided by:	Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:	NCT00159133

Purpose

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	Intervention	Phase
Schizophrenia Psychoses	Drug: antipsychotics vs. Lorazepam (Drugs)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Lorazepam

U.S. FDA Resources

Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:

relapse rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

psychopathology [ Time Frame: 1 year ] [ Designated as safety issue: No ]
social and cognitive functioning [ Time Frame: 1 year ] [ Designated as safety issue: No ]
side-effects [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
drop-out [ Time Frame: 1 year ] [ Designated as safety issue: No ]
quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	71
Study Start Date:	November 2001
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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;
2: Active Comparator 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;

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159133

Locations

Germany, North Rhine-Westphalia
German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 40629

Sponsors and Collaborators

Heinrich-Heine University, Duesseldorf

German Federal Ministry of Education and Research

German Research Network On Schizophrenia

Janssen-Cilag Ltd.

University Hospital, Bonn

Humboldt-Universität zu Berlin

Ludwig-Maximilians - University of Munich

University of Göttingen

University of Cologne

Mainz University

University Hospital Tuebingen

Univeristat Duisburg-Essen

University of Mannheim

University of Jena

Martin-Luther-Universität Halle-Wittenberg

RWTH Aachen University

University of Wuerzburg

Investigators

Study Chair:

Wolfgang Gaebel, Professor

Department of Psychiatry and Psychotherapy, University of Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf

More Information

Additional Information:

Click here for more information about this study: Pharmacological long-term treatment strategies for relapse prevention in first episode schizophrenia This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Gaebel W, Moller HJ, Buchkremer G, Ohmann C, Riesbeck M, Wolwer W, Von Wilmsdorff M, Bottlender R, Klingberg S. Pharmacological long-term treatment strategies in first episode schizophrenia--study design and preliminary results of an ongoing RCT within the German Research Network on Schizophrenia. Eur Arch Psychiatry Clin Neurosci. 2004 Apr;254(2):129-40.

Study ID Numbers:	01GI 9932 - P 2.2.2.2
Study First Received:	September 7, 2005
Last Updated:	January 28, 2008
ClinicalTrials.gov Identifier:	NCT00159133 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heinrich-Heine University, Duesseldorf:

Schizophrenia
first episode
prodrome based early intervention

antipsychotics - benzodiazepine
maintenance treatment
drug discontinuation

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Schizophrenia

Lorazepam
Autonomic Agents
Mental Disorders
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Psychotic Disorders
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 08, 2010