PsychosisNCT01781364
Neuroplasticity-oriented Cognitive Intervention in Early Onset and First Admission Schizophrenia
A study testing Brain Fitness Training, Posit Science SF in people with Psychosis, run by University of Konstanz at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 17 to 37 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Brain Fitness Training, Posit Science SF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 37 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Early Onset Psychosis
Who cannot join
- Chronicity
- Insufficient German skills
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to reveal the specific effects of computer-aided cognitive training on course and rehabilitation in early onset schizophrenia
Read the 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.
- Conditions
- Psychosis
- Being tested
- Brain Fitness Training, Posit Science SF
- Keywords
- Brain Oscillations, Cognitive Performance
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Fitness Training, Posit Science SFBehavioural
Computer aided cognitive training based on principles of neuroplasticity
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | Brain Fitness Training, Posit Science SF Receives: Behavioral: Brain Fitness Training, Posit Science SF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, post-training (training duration 4 weeks), 3-month follow-up, 7-month follow-up
Secondary outcomes (1)
change from baseline in GAF score at 3-months and 7-moths follow-up
Measured: baseline, 3-months follow-up, 7-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Brigitte Rockstroh, University of Konstanz
- Investigators
- Brigitte S Rockstroh, Prof. Dr., Study director, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781364
- Sponsor's protocol ID
- FP16963311
- Status last verified
- Dec 2014
- First submitted
- 22 Jan 2013
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroplasticity-oriented Cognitive Intervention in Early Onset and First Admission Schizophrenia
- ClinicalTrials.gov ID
- NCT01781364
- Acronym / sponsor ID
- FP16963311
- Conditions
- Psychosis
- Keywords
- Brain Oscillations, Cognitive Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Behavioral: Brain Fitness Training, Posit Science SFBrain Fitness Training, Posit Science SF |
Who may qualify
- Ages
- 17 to 37 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Early Onset Psychosis
Key exclusion criteria (2 listed)
- Chronicity
- Insufficient German skills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Fitness Training, Posit Science SFComputer aided cognitive training based on principles of neuroplasticity | Behavioural | Cognitive Training |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
Related trials for Psychosis
Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
RecruitingObservational study
Tau Biomarkers in Late-onset Psychosis (LOP)
Late Onset Schizophrenia, Delusional Disorder (Late Onset)
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis
Active, not recruitingObservational study
Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections
Severe Mental Illness, Inflammation
RecruitingPhase 3
Sequential Treatment Approaches for Treatment-Resistant Schizophrenia
Treatment-resistant Schizophrenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte S Rockstroh, Prof. Dr. study director
University of Konstanz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Fitness Training, Posit Science SF in people with Psychosis, run by University of Konstanz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2014.