NCT00159120

Brief Summary

After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions prodrome based early intervention take place.

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 episodeneuroleptic maintenance treatmentdrug discontinuationprodrome based early intervention

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

ACTIVE COMPARATOR

further maintenance antipsychotic treatment and prodrome-based early intervention

Other: maintained antipsychotic treatment vs. stepwise drug discontinuation

2

EXPERIMENTAL

stepwise drug discontinuation (after 1 year maintenance antipsychotic treatment) and prodrome-based early intervention

Other: maintained antipsychotic treatment vs. stepwise drug discontinuation

Interventions

maintained antipsychotic treatment vs. stepwise drug discontinuationOTHER

maintained antipsychotic treatment (in low dose) vs. stepwise drug discontinuation; both supplemented by prodrome-based early intervention; 1 year

12

Eligibility Criteria

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

You may qualify if:

  • Patients after 1 year of maintenance treatment after their first-episode in schizophrenia (according ICD-10 F20)
  • Age between 18 and 55
  • Informed consent
  • One year neuroleptic maintenance treatment
  • Reaching stable course

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 (3)

  • 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

  • Seemuller F, Schennach R, Mayr A, Musil R, Jager M, Maier W, Klingenberg S, Heuser I, Klosterkotter J, Gastpar M, Schmitt A, Schlosser R, Schneider F, Ohmann C, Lewitzka U, Gaebel W, Moller HJ, Riedel M; German Study Group on First-Episode Schizophrenia. Akathisia and suicidal ideation in first-episode schizophrenia. J Clin Psychopharmacol. 2012 Oct;32(5):694-8. doi: 10.1097/JCP.0b013e3182677958.

    PMID: 22926606DERIVED

  • Gaebel W, Riesbeck M, Wolwer W, Klimke A, Eickhoff M, von Wilmsdorff M, Lemke M, Heuser I, Maier W, Huff W, Schmitt A, Sauer H, Riedel M, Klingberg S, Kopcke W, Ohmann C, Moller HJ; German Study Group on First-Episode Schizophrenia. Relapse prevention in first-episode schizophrenia--maintenance vs intermittent drug treatment with prodrome-based early intervention: results of a randomized controlled trial within the German Research Network on Schizophrenia. J Clin Psychiatry. 2011 Feb;72(2):205-18. doi: 10.4088/JCP.09m05459yel. Epub 2010 Jun 29.

    PMID: 20673559DERIVED

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Wolfgang Gaebel, Professor

    Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University of Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf, Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
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)