NCT00159081

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for phase_4 schizophrenia

Timeline
Completed

Started Nov 2000

Longer than P75 for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

February 7, 2008

Status Verified

January 1, 2008

Enrollment Period

4.6 years

First QC Date

September 7, 2005

Last Update Submit

February 6, 2008

Conditions

Schizophrenia

Keywords

Schizophreniafirst episodelong-term treatmenttypical vs. atypical neuroleptics

Outcome Measures

Primary Outcomes (1)

  • relapse rate

    1 year

Secondary Outcomes (5)

  • course in psychopathology

    1 year

  • social and cognitive functioning

    1 year

  • side-effects

    1 year

  • drop-out

    1 year

  • quality of life

    1 year

Study Arms (2)

1

EXPERIMENTAL

Maintenance antipsychotic treatment with risperidone

Drug: Haloperidol, Risperidone (drug)

2

ACTIVE COMPARATOR

Maintenance antipsychotic treatment with haloperidol in low-dose

Drug: Haloperidol, Risperidone (drug)

Interventions

Haloperidol, Risperidone (drug)DRUG

targeted dose of 2-4 mg/day over 1 year

12

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • After the acute treatment of the first-episode in schizophrenia (according ICD-10 F20)
  • Age between 18 and 55
  • Informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, 40629, Germany

Location

Related Publications (2)

  • 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.

    PMID: 15146342BACKGROUND

  • Gaebel W, Riesbeck M, Wolwer W, Klimke A, Eickhoff M, von Wilmsdorff M, Jockers-Scherubl MC, Kuhn KU, Lemke M, Bechdolf A, Bender S, Degner D, Schlosser R, Schmidt LG, Schmitt A, Jager M, Buchkremer G, Falkai P, Klingberg S, Kopcke W, Maier W, Hafner H, Ohmann C, Salize HJ, Schneider F, Moller HJ; German Study Group on First-Episode Schizophrenia. Maintenance treatment with risperidone or low-dose haloperidol in first-episode schizophrenia: 1-year results of a randomized controlled trial within the German Research Network on Schizophrenia. J Clin Psychiatry. 2007 Nov;68(11):1763-74. doi: 10.4088/jcp.v68n1116.

    PMID: 18052570RESULT

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

HaloperidolRisperidonePharmaceutical Preparations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ButyrophenonesKetonesOrganic ChemicalsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Wolfgang Gaebel, Professor

    Department of Psychiatry and Psychotherapy, University of Duesseldorf

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

November 1, 2000

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

February 7, 2008

Record last verified: 2008-01

Locations

DE(1)