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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00159133
• Other study ID #: 01GI 9932 - P 2.2.2.2
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: January 28, 2008
• Start date: November 2001
• Est. completion date: June 2006

Study information

• Verified date: January 2008
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychoses
• Schizophrenia

Intervention

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;

Locations

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

Sponsors (17)

Lead Sponsor

Collaborator

Heinrich-Heine University, Duesseldorf

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

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Gaebel W, Möller HJ, Buchkremer G, Ohmann C, Riesbeck M, Wölwer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relapse rate		1 year	No
Secondary	psychopathology		1 year	No
Secondary	social and cognitive functioning		1 year	No
Secondary	side-effects		1 year	Yes
Secondary	drop-out		1 year	No
Secondary	quality of life		1 year	No

External Links

•   Click here for more information about this study: Pharmacological long-term treatment strategies for relapse prevention in first episode schizophrenia