Patient With Bipolar DisorderCOGMEDNCT02988518
Cognitive Remediation on Patients With Bipolar Disorder and Memory Complaints
A study testing COGMED program in people with Patient With Bipolar Disorder and Euthymic Status, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Bipolar disorder is a major health concern. Intercritical periods are marked with residual symptoms, both thymic and cognitive, which affects quality of life of patients, but also the quality of observance. The implementation of cognitive remediation programs could be interesting. Read more about this study
- Who is it for?
- Ages 18 months to 65 years
- Conditions the study is for
- Patient With Bipolar Disorder, Euthymic Status, Wirh Memory Complaints
- What is being tested?
- COGMED program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Nov 2017
- 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 18 months to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Being diagnosed bipolar according to the Diagnostic and Statistical Manual of Mental Disorders - IV (DSM-IV) criteria
- Memory complaints or overall performance alterations according to the memory scale (MEM III Wechsler memory scale - third edition)
- Being euthymic at the inclusion according to Montgomery-Asberg Depression Rating Scale (MADRS < 12) and Young Mania Rating Scale (YMRS < 6)
- Not being treated with electroconvulsive therapy for the last year
- Not having drug-dependance or drug-abuse for the last six months
- Having a computer with internet and a cellphone at home
- Having signed informed consent
- Able to understand nature, aims and methodology of the study
Who cannot join
- Patient on protective measures (guardianship or trusteeship)
- Deprived of liberty subject (judicial or administrative decision)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Montpellier University Hospital
Montpellier, 34295
Catherine GENTY, MD, +33 4 67 99 61 45 75, c-genty@chu-montpellier.fr
About this study
Official title: Evaluation of a Cognitive Remediation Program on Patients With Bipolar Disorders, With Memory Complaints
Bipolar disorder is a major health concern. Intercritical periods are marked with residual symptoms, both thymic and cognitive, which affects quality of life of patients, but also the quality of observance. The implementation of cognitive remediation programs could be interesting. The aim of this study is to evaluate the overall performance on euthymic bipolar patients with memory complaints included in the program named "COGMED", targeting the working memory.
The impact of this program on compliance, quality of life, and memory complaints will be evaluated.
Read more
The investigator will measure whether there is a correlation between working memory and overall performances.
Finally, the investigator will try to achieve a profile of bipolar patients in whom the Cogmed program is particularly effective on a plan of overall performance.
Read the detailed description
Patients with bipolar disorder and memory complaints will be recruited.
Two visits :
- at baseline (V0) : the investigator evaluate bipolar disorder, treatment, mood, quality of life, global functioning, and memory complaints. Patients also have a neuropsychological assessment. The COGMED program is proposed to patients with memory complaints and explain by the investigator
- 4-6 weeks after the end of the program (11-13 weeks after V1) : the same evaluation is realized to compare score before and after the program of cognitive remediation.
Between the two visits the patient will benefit of COGMED program, at home, during 5 weeks.
COGMED is a remediation cognitive program, based on working memory, consisting on daily exercises at home on a computer.
- Being tested
- COGMED program
- Keywords
- Psychiatry, Bipolar disorder, Memory complaints, Global functioning, Cognitive remediation, Working memory
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COGMED programBehavioural
Patient should connect on his computer at home, 5 times a week, for 5 weeks. Every day, the patient has to do 8 exercises for a total duration of 30 to 45 minutes.
In total, the patient will have to complete 25 sessions. The difficulty level of the proposed items adjust automatically to the patient's maximum capacity to compel him to provide a cognitive effort. A progression index assesses the progress made by the patient.
Every week, the investigator will call the patient for 10 minutes in order to gather the patient's feelings, his difficulties, provide some advice and encourage him.
The investigator will have to analyze the results of curves available for each event, as well as the patient's progress index.
| Study group | Role | What they receive |
|---|---|---|
| COGMED program | Experimental | Cognitive remediation using COGMED program on bipolar euthymic patients with memory complaints Receives: Behavioral: COGMED program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the global functioning between the inclusion and the end of the program
evaluation of variation of global functioning will be realized by the Functioning Assessment Short Test (FAST) scale after COGMED program.
Measured: At 4 weeks
Evolution of the global functioning between the inclusion and the end of the program
evaluation of variation of global functioning will be realized by the Functioning Assessment Short Test (FAST) scale after COGMED program
Measured: At 6 weeks
Secondary outcomes (4)
Observance
Evaluation of variation of patient's compliance by Medication Adherence Rating Scale (MARS) score after COGMED program.
Measured: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
Quality of life
Evaluation of variation of quality of life by Short Form (36) Health Survey (SF-36) score after COGMED program.
Measured: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
Correlation between working memory and global functioning
Searching a statistical correlation between global functioning (using FAST) and working memory (using neuropsychological tests)
Measured: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
Memory complaints
Variations on memory complaints will be evaluated by Mac Nair Scale score before and after COGMED program.
Measured: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startJul 2014
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient With Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988518
- Sponsor's protocol ID
- UF 9418
- Other IDs
- 2014-A00825-42
- Acronym
- COGMED
- Status last verified
- Jul 2016
- First submitted
- 1 Aug 2016
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Cognitive Remediation Program on Patients With Bipolar Disorders, With Memory Complaints
- ClinicalTrials.gov ID
- NCT02988518
- Acronym / sponsor ID
- COGMED / UF 9418
- Keywords
- Psychiatry, Bipolar disorder, Memory complaints, Global functioning, Cognitive remediation, Working memory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 9 Dec 2016 (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.
Bipolar disorder is a major health concern. Intercritical periods are marked with residual symptoms, both thymic and cognitive, which affects quality of life of patients, but also the quality of observance. The implementation of cognitive remediation programs could be interesting. The aim of this study is to evaluate the overall performance on euthymic bipolar patients with memory complaints included in the program named "COGMED", targeting the working memory.
The impact of this program on compliance, quality of life, and memory complaints will be evaluated.
The investigator will measure whether there is a correlation between working memory and overall performances.
Finally, the investigator will try to achieve a profile of bipolar patients in whom the Cogmed program is particularly effective on a plan of overall performance.
Detailed description
Patients with bipolar disorder and memory complaints will be recruited.
Two visits :
- at baseline (V0) : the investigator evaluate bipolar disorder, treatment, mood, quality of life, global functioning, and memory complaints. Patients also have a neuropsychological assessment. The COGMED program is proposed to patients with memory complaints and explain by the investigator
- 4-6 weeks after the end of the program (11-13 weeks after V1) : the same evaluation is realized to compare score before and after the program of cognitive remediation.
Between the two visits the patient will benefit of COGMED program, at home, during 5 weeks.
COGMED is a remediation cognitive program, based on working memory, consisting on daily exercises at home on a computer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COGMED program | Experimental | Behavioral: COGMED programCognitive remediation using COGMED program on bipolar euthymic patients with memory complaints |
Who may qualify
- Ages
- 18 months to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Being diagnosed bipolar according to the Diagnostic and Statistical Manual of Mental Disorders - IV (DSM-IV) criteria
- Memory complaints or overall performance alterations according to the memory scale (MEM III Wechsler memory scale - third edition)
- Being euthymic at the inclusion according to Montgomery-Asberg Depression Rating Scale (MADRS < 12) and Young Mania Rating Scale (YMRS < 6)
- Not being treated with electroconvulsive therapy for the last year
- Not having drug-dependance or drug-abuse for the last six months
Key exclusion criteria (2 listed)
- Patient on protective measures (guardianship or trusteeship)
- Deprived of liberty subject (judicial or administrative decision)
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 |
|---|---|---|
| COGMED programPatient should connect on his computer at home, 5 times a week, for 5 weeks. Every day, the patient has to do 8 exercises for a total duration of 30 to 45 minutes. In total, the patient will have to complete 25 sessions. The difficulty level of the proposed items adjust automatically to the patient's maximum capacity to compel him to provide a cognitive effort. A progression index assesses the progress made by the patient. Every week, the investigator will call the patient for 10 minutes in order to gather the patient's feelings, his difficulties, provide some advice and encourage him. The investigator will have to analyze the results of curves available for each event, as well as the patient's progress index. | Behavioural | COGMED program |
Primary outcome
Evolution of the global functioning between the inclusion and the end of the program
Time frame: At 4 weeks
evaluation of variation of global functioning will be realized by the Functioning Assessment Short Test (FAST) scale after COGMED program.
Evolution of the global functioning between the inclusion and the end of the program
Time frame: At 6 weeks
evaluation of variation of global functioning will be realized by the Functioning Assessment Short Test (FAST) scale after COGMED program
4 secondary outcomes
Observance
Time frame: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
Quality of life
Time frame: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
Correlation between working memory and global functioning
Time frame: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
Memory complaints
Time frame: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Patient With Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
RecruitingPhase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Schizophrenia, Bipolar Disorder
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COGMED program in people with Patient With Bipolar Disorder and Euthymic Status, run by University Hospital, Montpellier at 1 site in France.
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 8 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: status not confirmed, as of the sponsor's last update on 9 Dec 2016. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie OLIE, MD PhD (+33 4 67 33 85 81, e-olie@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the global functioning between the inclusion and the end of the program (time frame: At 4 weeks). The study lists 2 primary outcomes in all. 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 9 Dec 2016.