Bipolar DisorderPhase 1COGFLEXNCT01954680
Retrain Your Brain in Children/Adolescents With Bipolar Disorder: A Pilot Study
A Phase 1 study testing COGFLEX-skill building levels in people with Bipolar Disorder and Pediatric Bipolar Disorder, run by Bradley Hospital at 1 site in United States.
Trial summary
The main aim of this study is to test a new, non-medication computer-based potential treatment for bipolar disorder in children and adolescents. In the study, children and adolescents with bipolar disorder will come to our lab at Bradley Hospital 2-times per week for 8-weeks to "play" a custom computer "game" designed… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Bipolar Disorder, Pediatric Bipolar Disorder, Childhood-onset Bipolar Disorder
- What is being tested?
- COGFLEX-skill building levels
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Sep 2018
- Phase
- Phase 1
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 7-17 years old
- bipolar disorder type I preferred (at least 1 week of mania)
Who cannot join
- no implanted metal (no braces, no cochlear implants)
- can not have full Diagnostic and Statistical Manual 4th Edition (DSM-IV) autistic disorder
- no active drug/alcohol abuse/dependence
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Bradley Hospital
East Providence, Rhode Island, 02915
PediMIND Program, 401-432-1600, pedimind@gmail.com
Daniel Dickstein, M.D.
About this study
Official title: COGFLEX: Pilot Translational Intervention of Pediatric Bipolar Disorder
The main aim of this study is to test a new, non-medication computer-based potential treatment for bipolar disorder in children and adolescents.
In the study, children and adolescents with bipolar disorder will come to our lab at Bradley Hospital 2-times per week for 8-weeks to "play" a custom computer "game" designed to retrain the brain--to build a skill that my work has shown is impaired in children/adolescents with bipolar disorder.
Read more
Before and after this 8-week trial, children will have a special magnetic resonance imaging (MRI) scan.
This is a test of feasibility--meaning we want to see if the 8-week trial results in brain changes.
If it does, we will conduct a second study to see if it improves how bipolar children function--i.e., if it helps their illness.
Read the detailed description
Prior studies have shown that "computer assisted cognitive remediation"--meaning using computer "games" to build up a skill that has been shown to be impaired in a specific disorder--can result in improvement in psychiatric illnesses--including schizophrenia.
This will be the first National Institute of Mental Health (NIMH)-funded study to use this "retrain your brain" approach in children and adolescents with bipolar disorder.
During this study, we are seeking 40 children and adolescents with bipolar disorder to:
- come to our lab at Bradley Hospital in East Providence R.I. twice per week (each lasting 1 hour) to "play" a special computer game for a total of 8 weeks
- to have a special MRI before and after this 8-week trial to see if our "game" improves brain activity
- it does NOT matter if your child is already on medications--they can continue during this study
- all children/adolescents with bipolar disorder are welcome--as long as they do NOT have implanted metal (no braces, no cochlear implants, etc) because of magnetic resonance imaging (MRI) safety.
This is a test of feasibility--meaning we want to see if the 8-week trial results in brain changes.
If it does, we will conduct a second study to see if it improves how bipolar children function--i.e., if it helps their illness.
- Being tested
- COGFLEX-skill building levels, COGFLEX-control condition
- Keywords
- bipolar disorder, child, adolescent
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COGFLEX-skill building levelsBehavioural
Also called COGFLEX is a computer assisted cognitive remediation
COGFLEX--in English-- is a computer game designed to build up a specific skill that our work has shown is impaired in children and adolescents with bipolar disorder).
In the R33, children will be randomized to receive either COGFLEX with skill-building levels or COGFLEX-control condition which is just baseline/non-probabilistic trials.
All children will play COGFLEX twice per week for 8-weeks.
This same approach has shown great success in many psychiatric disorders including schizophrenia.
This is the first such study in children/adolescents with bipolar disorder.
COGFLEX-control conditionBehavioural
In the R33, the control condition will be the same COGFLEX "game"--but just baseline/non-probabilistic trials. All children will play COGFLEX twice per week for 8-weeks.
| Study group | Role | What they receive |
|---|---|---|
| COGFLEX-skill building levels | Experimental | In the R33, children will be randomized to receive either COGFLEX with skill-building levels or just baseline/non-probabilistic trials. All children will play COGFLEX twice per week for 8-weeks. Receives: Behavioral: COGFLEX-skill building levels |
| COGFLEX-control condition | Experimental | In the R33, children will be randomized to receive either COGFLEX with skill-building levels or the control condition--which is just baseline/non-probabilistic trials. All children will play COGFLEX twice per week for 8-weeks. Receives: Behavioral: COGFLEX-control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional magnetic resonance imaging (fMRI) brain activation
We will compare functional magnetic resonance imaging (fMRI) brain activation from week 1 (before intervention starts) to week 8 (after intervention is complete).
Measured: Change from week 1 to week 8
Secondary outcomes (1)
Change in Clinician global Impression Improvement-Irritability
Clinician global Impression Improvement-Irritability
Measured: Change from week 1 to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- R21 phase was an open phase 1a trial for feasibility and acceptability with enrollment goal including intervention development of 20. R33 phase enrollment goal of 40 including double-blind placebo-controlled randomized trial of 2 versions of video game potential intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bradley Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Daniel Dickstein, M.D., Principal investigator, Bradley Hospital/Alpert Medical School of Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954680
- Sponsor's protocol ID
- 0195-07 COGFLEX
- Other IDs
- R21MH096850, R33MH096850
- Acronym
- COGFLEX
- Status last verified
- Jan 2018
- First submitted
- 20 Sep 2013
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COGFLEX: Pilot Translational Intervention of Pediatric Bipolar Disorder
- ClinicalTrials.gov ID
- NCT01954680
- Acronym / sponsor ID
- COGFLEX / 0195-07 COGFLEX
- Keywords
- bipolar disorder, child, adolescent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bradley HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2013
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 7 Oct 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 main aim of this study is to test a new, non-medication computer-based potential treatment for bipolar disorder in children and adolescents.
In the study, children and adolescents with bipolar disorder will come to our lab at Bradley Hospital 2-times per week for 8-weeks to "play" a custom computer "game" designed to retrain the brain--to build a skill that my work has shown is impaired in children/adolescents with bipolar disorder.
Before and after this 8-week trial, children will have a special magnetic resonance imaging (MRI) scan.
This is a test of feasibility--meaning we want to see if the 8-week trial results in brain changes.
If it does, we will conduct a second study to see if it improves how bipolar children function--i.e., if it helps their illness.
Detailed description
Prior studies have shown that "computer assisted cognitive remediation"--meaning using computer "games" to build up a skill that has been shown to be impaired in a specific disorder--can result in improvement in psychiatric illnesses--including schizophrenia.
This will be the first National Institute of Mental Health (NIMH)-funded study to use this "retrain your brain" approach in children and adolescents with bipolar disorder.
During this study, we are seeking 40 children and adolescents with bipolar disorder to:
- come to our lab at Bradley Hospital in East Providence R.I. twice per week (each lasting 1 hour) to "play" a special computer game for a total of 8 weeks
- to have a special MRI before and after this 8-week trial to see if our "game" improves brain activity
- it does NOT matter if your child is already on medications--they can continue during this study
- all children/adolescents with bipolar disorder are welcome--as long as they do NOT have implanted metal (no braces, no cochlear implants, etc) because of magnetic resonance imaging (MRI) safety.
This is a test of feasibility--meaning we want to see if the 8-week trial results in brain changes.
If it does, we will conduct a second study to see if it improves how bipolar children function--i.e., if it helps their illness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- R21 phase was an open phase 1a trial for feasibility and acceptability with enrollment goal including intervention development of 20. R33 phase enrollment goal of 40 including double-blind placebo-controlled randomized trial of 2 versions of video game potential intervention.
| Arm | Type | Receives |
|---|---|---|
| COGFLEX-skill building levels | Experimental | Behavioral: COGFLEX-skill building levelsIn the R33, children will be randomized to receive either COGFLEX with skill-building levels or just baseline/non-probabilistic trials. All children will play COGFLEX twice per week for 8-weeks. |
| COGFLEX-control condition | Experimental | Behavioral: COGFLEX-control conditionIn the R33, children will be randomized to receive either COGFLEX with skill-building levels or the control condition--which is just baseline/non-probabilistic trials. All children will play COGFLEX twice per week for 8-weeks. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 7-17 years old
- bipolar disorder type I preferred (at least 1 week of mania)
Key exclusion criteria (3 listed)
- no implanted metal (no braces, no cochlear implants)
- can not have full Diagnostic and Statistical Manual 4th Edition (DSM-IV) autistic disorder
- no active drug/alcohol abuse/dependence
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 |
|---|---|---|
| COGFLEX-skill building levelsAlso: COGFLEX is a computer assisted cognitive remediationCOGFLEX--in English-- is a computer game designed to build up a specific skill that our work has shown is impaired in children and adolescents with bipolar disorder). In the R33, children will be randomized to receive either COGFLEX with skill-building levels or COGFLEX-control condition which is just baseline/non-probabilistic trials. All children will play COGFLEX twice per week for 8-weeks. This same approach has shown great success in many psychiatric disorders including schizophrenia. This is the first such study in children/adolescents with bipolar disorder. | Behavioural | COGFLEX-skill building levels |
| COGFLEX-control conditionIn the R33, the control condition will be the same COGFLEX "game"--but just baseline/non-probabilistic trials. All children will play COGFLEX twice per week for 8-weeks. | Behavioural | COGFLEX-control condition |
Primary outcome
Change in functional magnetic resonance imaging (fMRI) brain activation
Time frame: Change from week 1 to week 8
We will compare functional magnetic resonance imaging (fMRI) brain activation from week 1 (before intervention starts) to week 8 (after intervention is complete).
1 secondary outcome
Change in Clinician global Impression Improvement-Irritability
Time frame: Change from week 1 to week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
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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.
Daniel Dickstein, M.D. principal investigator
Bradley Hospital/Alpert Medical School of Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COGFLEX-skill building levels in people with Bipolar Disorder and Pediatric Bipolar Disorder, run by Bradley Hospital at 1 site in United States.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jan 2018. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in functional magnetic resonance imaging (fMRI) brain activation (time frame: Change from week 1 to week 8). 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 18 Jan 2018.