NCT00159133

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Nov 2001

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, 2001

Completed
3.9 years 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
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

January 30, 2008

Status Verified

January 1, 2008

Enrollment Period

4.6 years

First QC Date

September 7, 2005

Last Update Submit

January 28, 2008

Conditions

SchizophreniaPsychoses

Keywords

Schizophreniafirst episodeprodrome based early interventionantipsychotics - benzodiazepinemaintenance treatmentdrug discontinuation

Outcome Measures

Primary Outcomes (1)

  • relapse rate

    1 year

Secondary Outcomes (5)

  • 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

Early intervention with benzodiazepines in case of prodromal symptoms of an impending relapse

Drug: antipsychotics vs. Lorazepam (Drugs)

2

ACTIVE COMPARATOR

Early intervention with antipsychotics in case of prodromal symptoms of an impending relapse

Drug: antipsychotics vs. Lorazepam (Drugs)

Interventions

antipsychotics vs. Lorazepam (Drugs)DRUG

Early intervention with low-dose antipsychotics vs. lorazepam (up to 3 mg/day) in case of early warning signs of an impending relapse;

12

Eligibility Criteria

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

You may qualify if:

  • First-episode in schizophrenia (according ICD-10 F20)
  • Age between 18 and 55
  • Informed consent
  • One year neuroleptic maintenance treatment

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)

German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40629, Germany

Location

Related Publications (1)

  • 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

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Wolfgang Gaebel, Professor

    Department of Psychiatry and Psychotherapy, University of Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf

    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, 2001

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

January 30, 2008

Record last verified: 2008-01

Locations

DE(1)