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

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Psychoses
• Intervention / Treatment: Drug: antipsychotics vs. Lorazepam (Drugs)

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 Type: Interventional
• Enrollment (Anticipated): 71
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
relapse rate	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
quality of life	1 year
psychopathology	1 year
social and cognitive functioning	1 year
side-effects	1 year
drop-out	1 year

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Collaborators: German Federal Ministry of Education and Research; University of Cologne; RWTH Aachen University; Ludwig-Maximilians - University of Munich; University of Jena; University Hospital Tuebingen; Universität Duisburg-Essen; Martin-Luther-Universität Halle-Wittenberg; University of Wuerzburg; Janssen-Cilag Ltd.; University of Mannheim; University of Göttingen; Humboldt-Universität zu Berlin; University of Bonn; Mainz University; German Research Network On Schizophrenia
• Investigators: Study Chair: Wolfgang Gaebel, Professor, Department of Psychiatry and Psychotherapy, University of Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf

Publications and helpful links

General 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. doi: 10.1007/s00406-004-0509-y.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: November 1, 2001
• Primary Completion (ACTUAL): June 1, 2006
• Study Completion (ACTUAL): June 1, 2006

Study Registration Dates

• First Submitted: September 7, 2005
• First Submitted That Met QC Criteria: September 7, 2005
• First Posted (ESTIMATE): September 12, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): January 30, 2008
• Last Update Submitted That Met QC Criteria: January 28, 2008
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Keywords: Schizophrenia; maintenance treatment; first episode; drug discontinuation; prodrome based early intervention; antipsychotics - benzodiazepine
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Lorazepam; Antipsychotic Agents
• Other Study ID Numbers: 01GI 9932 - P 2.2.2.2