Neuroplasticity-oriented Cognitive Intervention in Early... | NCT01781364

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

NCT01781364

Sponsor

University of Konstanz

Status

Completed

Last Update Posted

Dec 16, 2014Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Psychosis

Interventions

Brain Fitness Training, Posit Science SF

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jan 22, 2013

First Submission Date that Met QC Criteria

Jan 30, 2013

First Posted Date

Feb 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2014

Last Update Posted Date

Dec 16, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cognitive Training	Experimental	Brain Fitness Training, Posit Science SF	Behavioral: Brain Fitness Training, Posit Science SF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brain Fitness Training, Posit Science SF	Behavioral	Computer aided cognitive training based on principles of neuroplasticity	Cognitive Training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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		baseline, post-training (training duration 4 weeks), 3-month follow-up, 7-month follow-up

Secondary Outcomes

Measure	Description	Time Frame
change from baseline in GAF score at 3-months and 7-moths follow-up		baseline, 3-months follow-up, 7-months follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Early Onset Psychosis

Exclusion Criteria:

Chronicity
Insufficient German skills

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

37 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brigitte S Rockstroh, Prof. Dr.	University of Konstanz	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Konstanz		Konstanz	Baden-Wurttemberg	78464	Germany

Condition Browse Module

MeSH Terms

ID	Term
D011618	Psychotic Disorders

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided