Bipolar DisorderREMEDINCT01457235
The Effects of Cognitive Remediation on Cognitive Function in Remitted Bipolar Disorder - a Proof of Concept Study
A study testing Cognitive Remediation in people with Bipolar Disorder, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Cognitive remediation (CR) is a new psychological treatment, which aims to improve cognitive function and coping skills. Several studies have recently demonstrated that CR improves cognitive and occupational function in patients with schizophrenia and with depression (e.g. Wykes et al 2007, Elgamal et al 2007). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Cognitive Remediation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2011to Jan 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Bipolar disorder in complete or partial remission (Hamilton Depression Rating Scale score of max 14 and Young Mania Scale score of max 14)
- Subjective complaints of moderate to severe cognitive problems on the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) (Fava et al 2006) (score at least 4 on at least 2 domains)
Who cannot join
- Current ECT treatment
- Drug and/or alcohol abuse
- Schizophrenia
- Significant risk of suicide
- Use of benzodiazepines equivalent to more than 22,5 milligrams of Alopam
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Psychiatric Centre Copenhagen, Rigshospitalet, Denmark
Copenhagen, 2100
About this study
Official title: The Effects of Cognitive Remediation on Cognitive Function in Remitted Bipolar Disorder - a Proof of Concept Study (REMEDI)
Cognitive remediation (CR) is a new psychological treatment, which aims to improve cognitive function and coping skills. Several studies have recently demonstrated that CR improves cognitive and occupational function in patients with schizophrenia and with depression (e.g. Wykes et al 2007, Elgamal et al 2007). However, it is unclear whether CR improves cognitive and socio-occupational function in individuals with bipolar disorder (BD) and, if so, what impact this might have on these people's abilities in terms of work, coping strategies, quality of life, and everyday safety.
The aim of the present PhD study is to investigate if CR has beneficial effects on cognitive and socio-occupational function in patients with previous mania and depression who experience persistent cognitive difficulties. Such effects would suggest implementation of CR in future treatment of bipolar disorder in order to facilitate the patients' ability to cope with the responsibilities related to work and everyday life. The hypotheses of the present study are that CR (in comparison to standard treatment) will 1) improve verbal learning and recall; and 2) improve sustained attention, executive function and psychosocial function.
- Conditions
- Bipolar Disorder
- Being tested
- Cognitive Remediation
- Keywords
- Bipolar disorder, Cognitive Remediation, Cognition, Cognitive function, Mood disorders, Affective disorders
- Medical subject headings
- Bipolar Disorder, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RemediationOther
All subjects will complete an MR brain scan, blood test, saliva test, and a neuropsychological battery of manual and computerised tests at baseline, at week 12 (end of active treatment) and week 26 (follow-up). Subjects randomly allocated to an active group will participate in a 12-week group-based cognitive remediation programme once a week for two hours. The waiting list group continues treatment as usual.
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Active comparator | This group receives cognitive remediation in groups (each group consisting of 6-8 subjects) Receives: Other: Cognitive Remediation |
| Waiting List | No intervention | Patients randomized to the waiting list group continues standard treatment and will be offered a course of cognitive remediation upon completion of participation provided that they still meet the inclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhance verbal learning and memory as reflected by increase in Rey Auditory Verbal Learning Test (RAVLT) total learning scores and recall
We expect a clinically relevant difference in the change between groups to be at least 4 points on RAVLT total scores.
Measured: Baseline and weeks 12 and 26
Secondary outcomes (3)
Improve sustained attention
Increase total scores of sustained attention measured with the Rapid Visual Information Processing (RVP) test from baseline to post treatment (week 12)
Measured: Baseline and weeks 12 and 26
Improve executive function
Increase total scores of executive function measured with the Trail Making Test (TMT) part B from baseline to post treatment (week 12)
Measured: Baseline and weeks 12 and 26
Increase psychosocial function
Increase psychosocial function measured with Functional Assessment Short Test (FAST) total scores from baseline to post treatment (week 12)
Measured: Baseline and weeks 12 and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark, Copenhagen University Hospital, Hvidovre
- Responsible party
- Principal investigator, Kamilla Miskowiak, Psychiatric Centre Rigshospitalet
- Investigators
- Kamilla W Miskowiak, Dr, Principal investigator, Psychiatric Centre Copenhagen, Rigshospitalet, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457235
- Sponsor's protocol ID
- H-1-2010-039
- Acronym
- REMEDI
- Status last verified
- Jan 2014
- First submitted
- 10 Oct 2011
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Demant KM, Vinberg M, Kessing LV, Miskowiak KW. Effects of Short-Term Cognitive Remediation on Cognitive Dysfunction in Partially or Fully Remitted Individuals with Bipolar Disorder: Results of a Randomised Controlled Trial. PLoS One. 2015 Jun 12;10(6):e0127955. doi: 10.1371/journal.pone.0127955. eCollection 2015.
PubMed 26070195Demant KM, Almer GM, Vinberg M, Kessing LV, Miskowiak KW. Effects of cognitive remediation on cognitive dysfunction in partially or fully remitted patients with bipolar disorder: study protocol for a randomized controlled trial. Trials. 2013 Nov 10;14:378. doi: 10.1186/1745-6215-14-378.
PubMed 24206639
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cognitive Remediation on Cognitive Function in Remitted Bipolar Disorder - a Proof of Concept Study (REMEDI)
- ClinicalTrials.gov ID
- NCT01457235
- Acronym / sponsor ID
- REMEDI / H-1-2010-039
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar disorder, Cognitive Remediation, Cognition, Cognitive function, Mood disorders, Affective disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark, Copenhagen University Hospital, Hvidovre
- Study start
- Aug 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 21 Oct 2011 (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.
Cognitive remediation (CR) is a new psychological treatment, which aims to improve cognitive function and coping skills. Several studies have recently demonstrated that CR improves cognitive and occupational function in patients with schizophrenia and with depression (e.g. Wykes et al 2007, Elgamal et al 2007). However, it is unclear whether CR improves cognitive and socio-occupational function in individuals with bipolar disorder (BD) and, if so, what impact this might have on these people's abilities in terms of work, coping strategies, quality of life, and everyday safety.
The aim of the present PhD study is to investigate if CR has beneficial effects on cognitive and socio-occupational function in patients with previous mania and depression who experience persistent cognitive difficulties. Such effects would suggest implementation of CR in future treatment of bipolar disorder in order to facilitate the patients' ability to cope with the responsibilities related to work and everyday life. The hypotheses of the present study are that CR (in comparison to standard treatment) will 1) improve verbal learning and recall; and 2) improve sustained attention, executive function and psychosocial function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Group | Active comparator | Other: Cognitive RemediationThis group receives cognitive remediation in groups (each group consisting of 6-8 subjects) |
| Waiting List | No intervention | –Patients randomized to the waiting list group continues standard treatment and will be offered a course of cognitive remediation upon completion of participation provided that they still meet the inclusion criteria. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Bipolar disorder in complete or partial remission (Hamilton Depression Rating Scale score of max 14 and Young Mania Scale score of max 14)
- Subjective complaints of moderate to severe cognitive problems on the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) (Fava et al 2006) (score at least 4 on at least 2 domains)
Key exclusion criteria (5 listed)
- Current ECT treatment
- Drug and/or alcohol abuse
- Schizophrenia
- Significant risk of suicide
- Use of benzodiazepines equivalent to more than 22,5 milligrams of Alopam
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 |
|---|---|---|
| Cognitive RemediationAll subjects will complete an MR brain scan, blood test, saliva test, and a neuropsychological battery of manual and computerised tests at baseline, at week 12 (end of active treatment) and week 26 (follow-up). Subjects randomly allocated to an active group will participate in a 12-week group-based cognitive remediation programme once a week for two hours. The waiting list group continues treatment as usual. | Other | Active Group |
Primary outcome
Enhance verbal learning and memory as reflected by increase in Rey Auditory Verbal Learning Test (RAVLT) total learning scores and recall
Time frame: Baseline and weeks 12 and 26
We expect a clinically relevant difference in the change between groups to be at least 4 points on RAVLT total scores.
3 secondary outcomes
Improve sustained attention
Time frame: Baseline and weeks 12 and 26
Improve executive function
Time frame: Baseline and weeks 12 and 26
Increase psychosocial function
Time frame: Baseline and weeks 12 and 26
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 30 Jan 2014.
- Derived from this study: PubMed 26070195Demant KM, Vinberg M, Kessing LV, Miskowiak KW. Effects of Short-Term Cognitive Remediation on Cognitive Dysfunction in Partially or Fully Remitted Individuals with Bipolar Disorder: Results of a Randomised Controlled Trial. PLoS One. 2015 Jun 12;10(6):e0127955. doi: 10.1371/journal.pone.0127955. eCollection 2015.
- Derived from this study: PubMed 24206639Demant KM, Almer GM, Vinberg M, Kessing LV, Miskowiak KW. Effects of cognitive remediation on cognitive dysfunction in partially or fully remitted patients with bipolar disorder: study protocol for a randomized controlled trial. Trials. 2013 Nov 10;14:378. doi: 10.1186/1745-6215-14-378.
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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.
Kamilla W Miskowiak, Dr principal investigator
Psychiatric Centre Copenhagen, Rigshospitalet, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation in people with Bipolar Disorder, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 5 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 30 Jan 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 Denmark. 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?
Enhance verbal learning and memory as reflected by increase in Rey Auditory Verbal Learning Test (RAVLT) total learning scores and recall (time frame: Baseline and weeks 12 and 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01457235, which also lists 2 linked publications.
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 30 Jan 2014.