NCT00161408

Brief Summary

The study is a randomized clinical trial investigating the efficacy of a comprehensive psychological intervention for the treatment of first episode schizophrenia

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
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

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

December 1, 2000

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
7 days 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

September 1, 2005

First QC Date

September 8, 2005

Last Update Submit

September 8, 2005

Conditions

Schizophrenic Disorders

Keywords

schizophrenia, first episode, cognitive behavioural therapy, psychoeducation

Outcome Measures

Primary Outcomes (1)

  • relapse

Secondary Outcomes (4)

  • quantitative measures of symptoms

  • social functioning

  • cognitive functioning

  • quality of life

Interventions

cognitive behavioural therapyBEHAVIORAL
psychoeducationBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • diagnosis of schizophrenic disorder according to ICD 10: F20
  • first episode
  • age between 18 and 55
  • willingness to give informed consent also to a double blind pharmacological treatment study

You may not qualify if:

  • residence outside of the catchment area
  • insufficient knowledge of the German language
  • substance abuse or addiction as primary clinical problem
  • serious physical illness
  • organic brain disease
  • pregnancy
  • contraindications to neuroleptic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Psychiatry and Psychotherapy, University of Bonn

Bonn, 53105, Germany

Location

Department of Psychiatry and Psychotherapy, University of Cologne

Cologne, 50924, Germany

Location

Department of Psychiatry and Psychotherapy, University of Duesseldorf

Düsseldorf, 40629, Germany

Location

Department of Psychiatry and Psychotheray, University of Muenchen

München, 80336, Germany

Location

Department of Psychiatry and Psychotherapy, University of Tuebingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Stefan Klingberg, PD Dr. phil. Dipl. Psych.

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

December 1, 2000

Study Completion

September 1, 2005

Last Updated

September 12, 2005

Record last verified: 2005-09

Locations

DE(5)