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

Information source: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: relapse rate

Secondary outcome:

psychopathology

social 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, 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.

Starting date: November 2001
Last updated: January 28, 2008

Page last updated: August 23, 2015

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