Bipolar DisorderNCT02793518
Mental Time Travel and Identity in Bipolar Disorder Patients
A study testing psychological tests in people with Bipolar Disorder, run by CHU de Reims at 1 site in France.
Trial summary
Self-defining memories (SDMs) are memories that are still important today to understand who the investigators are and participate to the maintain of personal identity. SDMs are also linked to our capacity to project ourselves into the future. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- psychological tests
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Oct 2016
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BD patients :
- Men or women, right-handed, with a diagnosis of type 1 bipolar disorder, according to the DSM-IV criteria, aged from 18 to 60 years-old
- Native French speaker
- Affiliated to the social security
- Accepting the study after reading the information note and signing the consentment form
- Healthy Controls (HC):
Show all 10Show fewer
- Men or women, right-handed, aged from 18 to 65 years-old
- Native French speaker
- Affiliated to the social security
- Accepting the study after reading the information note and signing the consentment form
Who cannot join
- BD patients :
- A recent alcohol and/or drug abuse or dependence
- A significant general medical illness, including neurological disorders or head trauma
- A sensorial impairment (visual and/or hearing)
- HC:
- A personal or first-degree-relative history of bipolar disorder, schizophrenia or schizoaffective disorder according to DSM-IV
Show all 9Show fewer
- A recent alcohol and/or drug abuse or dependence
- A significant general medical illness, including neurological disorders or head trauma
- A sensorial impairment (visual and/or hearing)
Trial locations and contacts
1 site in 1 country.
Delphine RAUCHER-CHENE contact
Sarah BARRIERE contact
France1 site, 1 recruiting
- Recruiting
Chu Reims
Reims, France, 51092
Delphine RAUCHER-CHENE
Sarah BARRIERE
About this study
Official title: Self-defining Memories and Future Projections in Bipolar Disorder Patients
Self-defining memories (SDMs) are memories that are still important today to understand who the investigators are and participate to the maintain of personal identity. SDMs are also linked to our capacity to project ourselves into the future. In bipolar disorder, life events play an important role in the course and outcome of the disease. the study is the first to investigate SDMs and self-defining future projections in a population of remitted patients with bipolar disorder.
Read the detailed description
Study design: case / control study in inclusion prospective, single center. population:
- A group of 30 patients aged 18 to 60 years and followed in the psychiatry department of adult CHU Reims for bipolar disorder type I (DSM-IV criteria).
- A group of 30 control subjects with no personal or family history of severe psychiatric disorder (bipolar disorder, schizophrenia or schizoaffective disorder), recruited from the staff of the University Hospital of Reims, the medical faculty of Reims or Marnais center health promotion of Reims, via the intranet and paper display.
The two groups will be matched for age (± 3 years), sex and educational level (± 2 years).
Plan of investigation: the study will be done in two visits:
- The first visit by a psychiatrist for:
- information on the objectives and the methods of research, verification criteria for inclusion and non-inclusion and participation of obtaining consent (written consent)
- comprehensive psychiatric evaluation and procurement different scales (anxiety scale, Hamilton depression scale, evaluation of verbal IQ, ...).
- 2nd visit, a maximum of 15 days after the first visit by a psychologist, neuropsychologist for the award of the memories of love and future projections defining self: the experimenter asks the subjects to relate memories 3 and 3 future projections. It is important personal events that arouse strong emotions and that the subjects often think.
Memories and projections reported by the subjects are then classified according to their emotional valence, their content, significance and degree of integration itself.
- Conditions
- Bipolar Disorder
- Being tested
- psychological tests
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychological testsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Disorder patients | Experimental | Not described Receives: Behavioral: psychological tests |
| Healthy Controls | Experimental | Not described Receives: Behavioral: psychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychological test : Mini International Neuropsychiatric Interview (M.I.N.I.)
Measured: Day 01
psychological test : State - Trait Anxiety Inventory Form Y
Measured: day 15
psychological test : Hamilton Depression Scale (HAM-D)
Measured: Day 01
psychological test : Mill Hill Vocabulary Scale
Measured: day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startMay 2013
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (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 CHU de ReimsThe 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793518
- Sponsor's protocol ID
- PA12064
- Status last verified
- May 2016
- First submitted
- 12 May 2016
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-defining Memories and Future Projections in Bipolar Disorder Patients
- ClinicalTrials.gov ID
- NCT02793518
- Acronym / sponsor ID
- PA12064
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 8 Jun 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.
Self-defining memories (SDMs) are memories that are still important today to understand who the investigators are and participate to the maintain of personal identity. SDMs are also linked to our capacity to project ourselves into the future. In bipolar disorder, life events play an important role in the course and outcome of the disease. the study is the first to investigate SDMs and self-defining future projections in a population of remitted patients with bipolar disorder.
Detailed description
Study design: case / control study in inclusion prospective, single center. population:
- A group of 30 patients aged 18 to 60 years and followed in the psychiatry department of adult CHU Reims for bipolar disorder type I (DSM-IV criteria).
- A group of 30 control subjects with no personal or family history of severe psychiatric disorder (bipolar disorder, schizophrenia or schizoaffective disorder), recruited from the staff of the University Hospital of Reims, the medical faculty of Reims or Marnais center health promotion of Reims, via the intranet and paper display.
The two groups will be matched for age (± 3 years), sex and educational level (± 2 years).
Plan of investigation: the study will be done in two visits:
- The first visit by a psychiatrist for:
- information on the objectives and the methods of research, verification criteria for inclusion and non-inclusion and participation of obtaining consent (written consent)
- comprehensive psychiatric evaluation and procurement different scales (anxiety scale, Hamilton depression scale, evaluation of verbal IQ, ...).
- 2nd visit, a maximum of 15 days after the first visit by a psychologist, neuropsychologist for the award of the memories of love and future projections defining self: the experimenter asks the subjects to relate memories 3 and 3 future projections. It is important personal events that arouse strong emotions and that the subjects often think.
Memories and projections reported by the subjects are then classified according to their emotional valence, their content, significance and degree of integration itself.
Study design
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar Disorder patients | Experimental | Behavioral: psychological tests |
| Healthy Controls | Experimental | Behavioral: psychological tests |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Men or women, right-handed, with a diagnosis of type 1 bipolar disorder, according to the DSM-IV criteria, aged from 18 to 60 years-old
- Native French speaker
- Affiliated to the social security
- Accepting the study after reading the information note and signing the consentment form
- Men or women, right-handed, aged from 18 to 65 years-old
Key exclusion criteria (9 listed)
- A recent alcohol and/or drug abuse or dependence
- A significant general medical illness, including neurological disorders or head trauma
- A sensorial impairment (visual and/or hearing)
- A personal or first-degree-relative history of bipolar disorder, schizophrenia or schizoaffective disorder according to DSM-IV
- A recent alcohol and/or drug abuse or 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 |
|---|---|---|
| psychological tests | Behavioural | Bipolar Disorder patients, Healthy Controls |
Primary outcome
psychological test : Mini International Neuropsychiatric Interview (M.I.N.I.)
Time frame: Day 01
psychological test : State - Trait Anxiety Inventory Form Y
Time frame: day 15
psychological test : Hamilton Depression Scale (HAM-D)
Time frame: Day 01
psychological test : Mill Hill Vocabulary Scale
Time frame: day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
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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.
Delphine RAUCHER-CHENE contact
Sarah BARRIERE contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychological tests in people with Bipolar Disorder, run by CHU de Reims 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 10 inclusion and 9 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 8 Jun 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 Delphine RAUCHER-CHENE (draucherchene@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychological test : Mini International Neuropsychiatric Interview (M.I.N.I.) (time frame: Day 01). The study lists 4 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 8 Jun 2016.