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Neuroplasticity-oriented Cognitive Intervention in Early Onset and First Admission Schizophrenia

Primary Purpose

Psychosis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Brain Fitness Training, Posit Science SF
Sponsored by
University of Konstanz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychosis focused on measuring Brain Oscillations, Cognitive Performance

Eligibility Criteria

17 Years - 37 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Early Onset Psychosis

Exclusion Criteria:

  • Chronicity
  • Insufficient German skills

Sites / Locations

  • University Konstanz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive Training

Arm Description

Brain Fitness Training, Posit Science SF

Outcomes

Primary Outcome Measures

change from baseline at post-training and at 3-months and at 7-months follow-up in each of the following outcome measures: neuropsychological test performance (MCCCB), GAF, PANSS, MEG event-related potentials (M50), alpha activity

Secondary Outcome Measures

change from baseline in GAF score at 3-months and 7-moths follow-up

Full Information

First Posted
January 22, 2013
Last Updated
December 15, 2014
Sponsor
University of Konstanz
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1. Study Identification

Unique Protocol Identification Number
NCT01781364
Brief Title
Neuroplasticity-oriented Cognitive Intervention in Early Onset and First Admission Schizophrenia
Official Title
Neuroplasticity-oriented Cognitive Intervention in Early Onset and First Admission Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to reveal the specific effects of computer-aided cognitive training on course and rehabilitation in early onset schizophrenia
Detailed Description
Impairment in cognitive functions is one of the main symptoms in schizophrenia and is currently one of the challenges in the treatment of the disease. We examine the beneficial effect of computer-aided training program on course and rehabilitation of young psychotic patients with early onset psychosis. In addition we develop predictors for the course of disorder from neuroimaging data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
Brain Oscillations, Cognitive Performance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Training
Arm Type
Experimental
Arm Description
Brain Fitness Training, Posit Science SF
Intervention Type
Behavioral
Intervention Name(s)
Brain Fitness Training, Posit Science SF
Intervention Description
Computer aided cognitive training based on principles of neuroplasticity
Primary Outcome Measure Information:
Title
change from baseline at post-training and at 3-months and at 7-months follow-up in each of the following outcome measures: neuropsychological test performance (MCCCB), GAF, PANSS, MEG event-related potentials (M50), alpha activity
Time Frame
baseline, post-training (training duration 4 weeks), 3-month follow-up, 7-month follow-up
Secondary Outcome Measure Information:
Title
change from baseline in GAF score at 3-months and 7-moths follow-up
Time Frame
baseline, 3-months follow-up, 7-months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Early Onset Psychosis Exclusion Criteria: Chronicity Insufficient German skills
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte S Rockstroh, Prof. Dr.
Organizational Affiliation
University of Konstanz
Official's Role
Study Director
Facility Information:
Facility Name
University Konstanz
City
Konstanz
State/Province
Baden Wuerttemberg
ZIP/Postal Code
78464
Country
Germany

12. IPD Sharing Statement

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Neuroplasticity-oriented Cognitive Intervention in Early Onset and First Admission Schizophrenia

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