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One Year Drug Treatment 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

Intervention: Haloperidol, Risperidone (drug) (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 Duesseldorf


Prospective, randomized, double-blind, multi-center study on 1 year course and treatment outcome under low-dose typical (haloperidol) vs. atypical neuroleptics (risperidone) in first-episode schizophrenia.

Clinical Details

Official title: One Year Maintenance Treatment With Low Dose Haloperidol vs. Risperidone in First-Episode Schizophrenia

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:

course in psychopathology

social and cognitive functioning



quality of life

Detailed description: The objective of this multi-center study is to optimize the long-term treatment of patients with first episode schizophrenia. This investigation should contribute to the issue of effective relapse prevention in first-episode patients. 1-year maintenance neuroleptic treatment is done with low dose haloperidol or risperidone (target dose 2-4 mg/die).


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion Criteria:

- After the acute treatment of the first-episode in schizophrenia (according ICD-10


- Age between 18 and 55

- Informed consent

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

Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University, Duesseldorf, North Rhine-Westphalia 40629, Germany
Additional Information

Click here for more information about this study: One year maintenance treatment with low dose Haloperidol vs. Risperidone 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 2000
Last updated: February 6, 2008

Page last updated: August 23, 2015

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