search
Back to results

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

Primary Purpose

Schizophrenia, Psychoses

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
antipsychotics vs. Lorazepam (Drugs)
Sponsored by
Heinrich-Heine University, Duesseldorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, first episode, prodrome based early intervention, antipsychotics - benzodiazepine, maintenance treatment, drug discontinuation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

relapse rate

Secondary Outcome Measures

psychopathology
social and cognitive functioning
side-effects
drop-out
quality of life

Full Information

First Posted
September 7, 2005
Last Updated
January 28, 2008
Sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
German Federal Ministry of Education and Research, German Research Network On Schizophrenia, Janssen-Cilag Ltd., University of Bonn, Humboldt-Universität zu Berlin, Ludwig-Maximilians - University of Munich, University of Göttingen, University of Cologne, Mainz University, University Hospital Tuebingen, Universität Duisburg-Essen, University of Mannheim, University of Jena, Martin-Luther-Universität Halle-Wittenberg, RWTH Aachen University, University of Wuerzburg
search

1. Study Identification

Unique Protocol Identification Number
NCT00159133
Brief Title
Prodrome-Based Early Intervention With Antipsychotics vs. Benzodiazepines in First-Episode Schizophrenia
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 Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psychoses
Keywords
Schizophrenia, first episode, prodrome based early intervention, antipsychotics - benzodiazepine, maintenance treatment, drug discontinuation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
71 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Early intervention with benzodiazepines in case of prodromal symptoms of an impending relapse
Arm Title
2
Arm Type
Active Comparator
Arm Description
Early intervention with antipsychotics in case of prodromal symptoms of an impending relapse
Intervention Type
Drug
Intervention Name(s)
antipsychotics vs. Lorazepam (Drugs)
Intervention Description
Early intervention with low-dose antipsychotics vs. lorazepam (up to 3 mg/day) in case of early warning signs of an impending relapse;
Primary Outcome Measure Information:
Title
relapse rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
psychopathology
Time Frame
1 year
Title
social and cognitive functioning
Time Frame
1 year
Title
side-effects
Time Frame
1 year
Title
drop-out
Time Frame
1 year
Title
quality of life
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Gaebel, Professor
Organizational Affiliation
Department of Psychiatry and Psychotherapy, University of Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf
Official's Role
Study Chair
Facility Information:
Facility Name
German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf
City
Düsseldorf
State/Province
North Rhine-Westphalia
ZIP/Postal Code
40629
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
15146342
Citation
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. doi: 10.1007/s00406-004-0509-y.
Results Reference
background
Links:
URL
http://www.kompetenznetz-schizophrenie.de
Description
Click here for more information about this study: Pharmacological long-term treatment strategies for relapse prevention in first episode schizophrenia

Learn more about this trial

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

We'll reach out to this number within 24 hrs