Bipolar DisorderRechuteBPNCT02572674
Study of Predictor of Mood Relapse in Bipolar Disorders
A study testing Experimental follow up and Genetic sample in people with Bipolar Disorder and Euthymic State, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Study in 400 patients with bipolar disorder I or II, of relapse risk factors. The principal objective of this research is to test the predictive value of core vulnerability dimensions such as affective instability and emotional reactivity, measured by validated questionnaires (AIM and ALS) on recurrence of affective… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Bipolar Disorder, Euthymic State
- What is being tested?
- Experimental follow up and Genetic sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteFrance
- Study dates
- May 2010to Dec 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Bipolar disorder I or II
- French language
- Aging between 18 years and 55 years
- Young Mania Rating Scale (YMRS) < 12
- Montgomery Asberg Depression Rating Scale (MDRS) < 10
Who cannot join
- Rapid cycling
- Undefined number of major relapses
- Drug and alcohol abuse within 6 months
- Electroconvulsive therapy (ECT) within 12 months
- Epilepsy, traumatism cranial or other neurological diseases
- Daltonism or visual trouble
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Predictor of Mood Relapse in Bipolar Disorders : Prospective, Clinical, Neuropsychological, Biological and Genetic Study
Study in 400 patients with bipolar disorder I or II, of relapse risk factors. The principal objective of this research is to test the predictive value of core vulnerability dimensions such as affective instability and emotional reactivity, measured by validated questionnaires (AIM and ALS) on recurrence of affective major episode (depressed, hypomanic or manic) during a 24 months prospective follow-up.
In addition, several arguments suggest that inter-individual variability in the risk of relapse is influenced by genetic factors. In particular, the implication of such factors have been demonstrated in rapid cycling or antidepressants induced mania. However, this has never been tested in cohorts followed prospectively. Finally, the existence of neuropsychological deficits in bipolar disorder is well documented and their role in the risk of relapse is suspected. Yet the nature of these deficits, their origin and evolutionary course remain poorly investigated. In summary, the secondary objectives of this research are the study of the influence of these other clinical, neuropsychological and genetic factors on the risk of relapse.
Read more
- Scientific rationale The dimensions of affective instability and emotional reactivity, are considered core psychological and temperamental vulnerability dimensions to bipolar disorder. Differences in levels of instability and reactivity may account for the inter-individual variability observed in bipolar disorder in terms of risk of relapse. These dimensions are measured using validated questionnaires (Affective Instability Measure (AIM) and Affective Lability Scale (ALS)). Relapsing is defined as the occurrence of a depressive episode, hypomanic, manic or mixed episode (DSMIV criteria).
Other factors that may influence the risk of relapse have been suggested in the literature but have not been formally tested in prospective studies:
- cognitive deficits: the existence of neuropsychological deficits in bipolar disorder are well documented and their role in the risk of relapse is suspected. Yet the nature of these deficits, their origin and their course remain poorly investigated. Indeed, some appear to be related to the neurotoxicity of the episodes themselves, the other being related to the vulnerability to bipolar disorder
- The involvement of genetic vulnerability factors in bipolar disorder is widely demonstrated. Several arguments suggest the implication of genetic factors in the risk of relapse. This is the case for some outcome patterns such as rapid cycling or antidepressants induced mania. Again, this has never been tested in cohorts followed prospectively.
- The role of certain inflammatory and infectious factors in the etiology of bipolar disorder has been suggested but it is clear whether these biomarkers are "state" or "traits". Thus, the role of neurotoxic inflammatory or infectious factors in relapse mood has never been tested in a prospective follow up studies.
- Main objective of the project To determine if the scores of AIM and ALS, assessed at baseline in euthymic bipolar patients is associated with relapse in patients during a 2 years follow-up period.
- Secondary objectives of the project Determine if the neuropsychological performance at T0, measured in euthymic patients predict relapse during a 2 years follow-up period.
Determine whether the neuropsychological deficits observed in euthymic bipolar patients that contribute to functional impairment worsen with time.
DNA collection to test the involvement of candidate genes Serum collection to study the biological and infectious biomarkers
- Methodology Prospective follow up studies. Multicenter.
- Conditions
- Bipolar Disorder, Euthymic State
- Being tested
- Experimental follow up, Genetic sample
- Keywords
- Bipolar disorder, relapse risk factors, prospective follow up
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental follow upOther
Neuropsychological assessment (intellectual functioning, episodic verbal memory, processing speed, attention, working verbal memory, working visual memory, executive function)
Genetic sampleGenetic
Blood samples
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Other | Experimental follow up : Neuropsychological assessment at 6 month and genetic samples Receives: Other: Experimental follow up; Genetic: Genetic sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined outcome based on AIM and ALS's score assessed at baseline in euthymic bipolar patients associated with relapse in patients during a 2 years follow-up period.
Measured: 24 months
Secondary outcomes (2)
Global neuropsychological performance based on combined score of all neuropsychological scales (detail below) at T0, measured in euthymic patients predict relapse during a 2 years follow-up period.
Neuropsychological scales : intellectual functioning, episodic verbal memory, processing speed, attention, working verbal memory, working visual memory, executive function
Measured: 24 months
Global neuropsychological deficits based on combined score of all neuropsychological scales (detail below) observed in euthymic bipolar patients that contribute to functional impairment worsen with time
Neuropsychological scales : intellectual functioning, episodic verbal memory, processing speed, attention, working verbal memory, working visual memory, executive function
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startMay 2010
- Primary completionAug 2016
- Study completionDec 2017 (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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank BELLIVIVIER, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572674
- Sponsor's protocol ID
- P071245
- Acronym
- RechuteBP
- Status last verified
- Jun 2017
- First submitted
- 13 Aug 2015
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Predictor of Mood Relapse in Bipolar Disorders : Prospective, Clinical, Neuropsychological, Biological and Genetic Study
- ClinicalTrials.gov ID
- NCT02572674
- Acronym / sponsor ID
- RechuteBP / P071245
- Conditions
- Bipolar Disorder, Euthymic State
- Keywords
- Bipolar disorder, relapse risk factors, prospective follow up
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Oct 2015 (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.
Study in 400 patients with bipolar disorder I or II, of relapse risk factors. The principal objective of this research is to test the predictive value of core vulnerability dimensions such as affective instability and emotional reactivity, measured by validated questionnaires (AIM and ALS) on recurrence of affective major episode (depressed, hypomanic or manic) during a 24 months prospective follow-up.
In addition, several arguments suggest that inter-individual variability in the risk of relapse is influenced by genetic factors. In particular, the implication of such factors have been demonstrated in rapid cycling or antidepressants induced mania. However, this has never been tested in cohorts followed prospectively. Finally, the existence of neuropsychological deficits in bipolar disorder is well documented and their role in the risk of relapse is suspected. Yet the nature of these deficits, their origin and evolutionary course remain poorly investigated. In summary, the secondary objectives of this research are the study of the influence of these other clinical, neuropsychological and genetic factors on the risk of relapse.
- Scientific rationale The dimensions of affective instability and emotional reactivity, are considered core psychological and temperamental vulnerability dimensions to bipolar disorder. Differences in levels of instability and reactivity may account for the inter-individual variability observed in bipolar disorder in terms of risk of relapse. These dimensions are measured using validated questionnaires (Affective Instability Measure (AIM) and Affective Lability Scale (ALS)). Relapsing is defined as the occurrence of a depressive episode, hypomanic, manic or mixed episode (DSMIV criteria).
Other factors that may influence the risk of relapse have been suggested in the literature but have not been formally tested in prospective studies:
- cognitive deficits: the existence of neuropsychological deficits in bipolar disorder are well documented and their role in the risk of relapse is suspected. Yet the nature of these deficits, their origin and their course remain poorly investigated. Indeed, some appear to be related to the neurotoxicity of the episodes themselves, the other being related to the vulnerability to bipolar disorder
- The involvement of genetic vulnerability factors in bipolar disorder is widely demonstrated. Several arguments suggest the implication of genetic factors in the risk of relapse. This is the case for some outcome patterns such as rapid cycling or antidepressants induced mania. Again, this has never been tested in cohorts followed prospectively.
- The role of certain inflammatory and infectious factors in the etiology of bipolar disorder has been suggested but it is clear whether these biomarkers are "state" or "traits". Thus, the role of neurotoxic inflammatory or infectious factors in relapse mood has never been tested in a prospective follow up studies.
- Main objective of the project To determine if the scores of AIM and ALS, assessed at baseline in euthymic bipolar patients is associated with relapse in patients during a 2 years follow-up period.
- Secondary objectives of the project Determine if the neuropsychological performance at T0, measured in euthymic patients predict relapse during a 2 years follow-up period.
Determine whether the neuropsychological deficits observed in euthymic bipolar patients that contribute to functional impairment worsen with time.
DNA collection to test the involvement of candidate genes Serum collection to study the biological and infectious biomarkers
- Methodology Prospective follow up studies. Multicenter.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Other | Other: Experimental follow up, Genetic: Genetic sampleExperimental follow up : Neuropsychological assessment at 6 month and genetic samples |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Bipolar disorder I or II
- French language
- Aging between 18 years and 55 years
- Young Mania Rating Scale (YMRS) < 12
- Montgomery Asberg Depression Rating Scale (MDRS) < 10
Key exclusion criteria (6 listed)
- Rapid cycling
- Undefined number of major relapses
- Drug and alcohol abuse within 6 months
- Electroconvulsive therapy (ECT) within 12 months
- Epilepsy, traumatism cranial or other neurological diseases
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 |
|---|---|---|
| Experimental follow upNeuropsychological assessment (intellectual functioning, episodic verbal memory, processing speed, attention, working verbal memory, working visual memory, executive function) | Other | experimental arm |
| Genetic sampleBlood samples | Genetic | experimental arm |
Primary outcome
Combined outcome based on AIM and ALS's score assessed at baseline in euthymic bipolar patients associated with relapse in patients during a 2 years follow-up period.
Time frame: 24 months
2 secondary outcomes
Global neuropsychological performance based on combined score of all neuropsychological scales (detail below) at T0, measured in euthymic patients predict relapse during a 2 years follow-up period.
Time frame: 24 months
Global neuropsychological deficits based on combined score of all neuropsychological scales (detail below) observed in euthymic bipolar patients that contribute to functional impairment worsen with time
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
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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.
Frank BELLIVIVIER, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental follow up and Genetic sample in people with Bipolar Disorder and Euthymic State, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 6 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 20 Jun 2017. 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?
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?
Combined outcome based on AIM and ALS's score assessed at baseline in euthymic bipolar patients associated with relapse in patients during a 2 years follow-up period. (time frame: 24 months). 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 20 Jun 2017.