NCT00157378

Brief Summary

The study is a multicenter, double-blind, randomized, parallel-group study with first episode schizophrenic patients. During a treatment phase of 8 weeks the patients are treated with Risperidone or Haloperidol. Aim of the project is to compare the effects of the atypical neuroleptic Risperidone with those of the conventional neuroleptic Haloperidol and to evaluate whether the assumed advantages of atypical neuroleptics compared to conventional neuroleptics are also present when both medications are administered in rather low daily dosages (min. 2 mg/d; max. 8 mg/d).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2000

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

September 12, 2005

Status Verified

January 1, 2000

First QC Date

September 8, 2005

Last Update Submit

September 8, 2005

Conditions

Schizophrenia, First-Episode

Keywords

first episode,schizophrenia,atypical neuroleptics,negative symptoms

Outcome Measures

Primary Outcomes (1)

  • weekly assessment of psychopathology (e.g.PANSS)and side-effects

Secondary Outcomes (3)

  • cognitive disability

  • depression

  • life quality at time of admission & end of study

Interventions

Risperidone, HaloperidolDRUG

Eligibility Criteria

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

You may qualify if:

  • ICD-10 criteria for first episode schizophrenia
  • age between 18 and 55
  • informed consent

You may not qualify if:

  • 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, Ludwig-Maximilians-University

Munich, 80336, Germany

Location

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

RisperidoneHaloperidol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsButyrophenonesKetonesOrganic Chemicals

Study Officials

  • Hans-Jürgen Möller, Professor

    Department of Psychiatry, Ludwig-Maximilians-University Munich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

November 1, 2000

Study Completion

December 1, 2004

Last Updated

September 12, 2005

Record last verified: 2000-01

Locations

DE(1)