Conditions Influencing Health StatusBIP-EDNCT01821469
Functional Correlates of Bipolar Disorders and Effects of the Psychoeducation. an fMRI Study
A study testing psychoeducation in people with Conditions Influencing Health Status and Bipolar Disorders, run by University Hospital, Grenoble at 1 site in France.
Trial summary
This research project follows two main objectives: 1) Assess anatomical and functional cerebral abnormalities in bipolar disorder. 2) Evaluate anatomical and functional changes after the application of a psychoeducational program in these patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Conditions Influencing Health Status, Bipolar Disorders
- What is being tested?
- psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Dec 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- clinical diagnosis of bipolar disorders
- euthymic (Montgomery and Asberg depression rating scale < 10, Young Mania rating scale < 10)
Who cannot join
- other concomitant psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Correlates of Bipolar Disorders and Effects of the Psychoeducation. Assessment by Functional and Anatomic Neuroimaging.
This research project follows two main objectives: 1) Assess anatomical and functional cerebral abnormalities in bipolar disorder. 2) Evaluate anatomical and functional changes after the application of a psychoeducational program in these patients. Specifically, this project aims to assess neurophysiological (fMRI - activation and functional connectivity) and neuroanatomical (morphometry and diffusion tensor imaging) specificities related to bipolar disorders and the therapeutic response to the psychoeducation. The results of this thesis project would also contribute to the validation of a pathophysiological model of the bipolar disorder.
- Being tested
- psychoeducation
- Keywords
- bipolar disorders, euthymic, psychotherapy, Functional magnetic resonance imaging
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychoeducationBehavioural
Bipolar disorders are educated to learn about their pathology
| Study group | Role | What they receive |
|---|---|---|
| psychoeducation | Experimental | psychoeducation (12 weeks) Receives: Behavioral: psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI measurement (neurophysiological [fMRI - activation and functional connectivity])
measurements were performed before (T1) and after (T2) educational program of 12 sessions .One session last one hour and half once a week (they come at the hospital for all sessions : i.e. during 12 weeks). Thus, T1 to T2 is 3 months (average).
Measured: measurements were performed at T1 and T2 (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startMay 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conditions Influencing Health StatusStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AdministrateurDRC, University Hospital, Grenoble
- Investigators
- Thierry Bougerol, professor, Principal investigator, CHU grenoble pôle psychiatrie et neurologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821469
- Sponsor's protocol ID
- EssaiClinique_"BIP-ED"
- Other IDs
- 2011-A00425-36
- Acronym
- BIP-ED
- Status last verified
- Jan 2014
- First submitted
- 6 Nov 2012
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Favre P, Polosan M, Pichat C, Bougerol T, Baciu M. Cerebral Correlates of Abnormal Emotion Conflict Processing in Euthymic Bipolar Patients: A Functional MRI Study. PLoS One. 2015 Aug 5;10(8):e0134961. doi: 10.1371/journal.pone.0134961. eCollection 2015.
PubMed 26244883
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Correlates of Bipolar Disorders and Effects of the Psychoeducation. Assessment by Functional and Anatomic Neuroimaging.
- ClinicalTrials.gov ID
- NCT01821469
- Acronym / sponsor ID
- BIP-ED / EssaiClinique_"BIP-ED"
- Keywords
- bipolar disorders, euthymic, psychotherapy, Functional magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 Apr 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.
This research project follows two main objectives: 1) Assess anatomical and functional cerebral abnormalities in bipolar disorder. 2) Evaluate anatomical and functional changes after the application of a psychoeducational program in these patients. Specifically, this project aims to assess neurophysiological (fMRI - activation and functional connectivity) and neuroanatomical (morphometry and diffusion tensor imaging) specificities related to bipolar disorders and the therapeutic response to the psychoeducation. The results of this thesis project would also contribute to the validation of a pathophysiological model of the bipolar disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| psychoeducation | Experimental | Behavioral: psychoeducationpsychoeducation (12 weeks) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of bipolar disorders
- euthymic (Montgomery and Asberg depression rating scale < 10, Young Mania rating scale < 10)
Key exclusion criteria (1 listed)
- other concomitant psychiatric disorders
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 |
|---|---|---|
| psychoeducationBipolar disorders are educated to learn about their pathology | Behavioural | psychoeducation |
Primary outcome
fMRI measurement (neurophysiological [fMRI - activation and functional connectivity])
Time frame: measurements were performed at T1 and T2 (up to 3 months)
measurements were performed before (T1) and after (T2) educational program of 12 sessions .One session last one hour and half once a week (they come at the hospital for all sessions : i.e. during 12 weeks). Thus, T1 to T2 is 3 months (average).
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 28 Jan 2014.
- Derived from this study: PubMed 26244883Favre P, Polosan M, Pichat C, Bougerol T, Baciu M. Cerebral Correlates of Abnormal Emotion Conflict Processing in Euthymic Bipolar Patients: A Functional MRI Study. PLoS One. 2015 Aug 5;10(8):e0134961. doi: 10.1371/journal.pone.0134961. eCollection 2015.
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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.
Thierry Bougerol, professor principal investigator
CHU grenoble pôle psychiatrie et neurologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychoeducation in people with Conditions Influencing Health Status and Bipolar Disorders, run by University Hospital, Grenoble 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 2 inclusion and 1 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 28 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 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?
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?
fMRI measurement (neurophysiological [fMRI - activation and functional connectivity]) (time frame: measurements were performed at T1 and T2 (up to 3 months)). 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 NCT01821469, which also lists 1 linked publication.
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 28 Jan 2014.