Prodrome-Based Early Intervention With Antipsychotics vs. Benzodiazepines in First-Episode Schizophrenia
Information source: Heinrich-Heine University, Duesseldorf
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Psychoses
Intervention: antipsychotics vs. Lorazepam (Drugs) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Heinrich-Heine University, Duesseldorf Official(s) and/or principal investigator(s):
Wolfgang Gaebel, Professor, Study Chair, Affiliation: Department of Psychiatry and Psychotherapy, University of Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: relapse rate
Secondary outcome: psychopathologysocial and cognitive functioning side-effects drop-out quality of life
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
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf, Düsseldorf, North Rhine-Westphalia 40629, Germany
Additional Information
Click here for more information about this study: Pharmacological long-term treatment strategies for relapse prevention in first episode schizophrenia
Related 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.
Starting date: November 2001
Ending date: June 2006
Last updated: January 28, 2008
|
