Bipolar DisorderNCT02036606
Racing and Crowded Thoughts in Mood Disorders
An observational study of Bipolar Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Racing thoughts relate to subjective acceleration of thinking which has been essentially associated with manic episodes in bipolar disorder. Qualitatively, the phenomenology of racing thoughts in major depression seems to differ from rumination and pure manic racing thoughts: thoughts of all kinds accumulate in the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- questionary
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Apr 2020
- Phase
- Observational
- 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
Study population: Primary care clinic
Who may be able to join
- Bipolar disorder or depressive disorder
- 18 -65 years old
Who cannot join
- neurological conditions or sequelae
- substance abuse in the last 10 months
- schizophrenia
- ADHD
- Borderline personality disorder
- Pregnant women- Subjects under legal supervision
Trial locations and contacts
1 site in 1 country.
Dimitri Sanchez contact
France1 site, 1 recruiting
- Recruiting
Service de psychiatrie 2 , Les Hôpitaux Universitaires de Strasbourg
Strasbourg, Alsace, 67091
Gilles Bertschy, PHD MD, gilles.bertschy@chru-strasbourg.fr
Gilles Bertschy, PHD MD
About this study
Official title: Psychopathological and Cognitive Mechanisms of Racing and Crowded Thoughts in Mood Disorders
Racing thoughts relate to subjective acceleration of thinking which has been essentially associated with manic episodes in bipolar disorder. Qualitatively, the phenomenology of racing thoughts in major depression seems to differ from rumination and pure manic racing thoughts: thoughts of all kinds accumulate in the patient's head. Recent qualitative evidence is consistent with the existence of these two kinds of "thought overactivity" related to mood disorders. In order to evaluate this and better understand the psychopathological and cognitive mechanisms that underlie thought overactivity in mood disorders, we have created a 34-item self-questionnaire - the Racing and Crowded Thoughts Questionnaire (RCTQ) and a number of neuropsychological tasks (time perception, cognitive flexibility). Also, given the relationship between mood disorders and creativity, it is likely that thought overactivity is related to increased creativity. We aim at evaluating this relationship through the French version of the Cognitive Processes Associated with Creativity scale (CPAC).
- Conditions
- Bipolar Disorder
- Being tested
- questionary
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionaryBehavioural
| Study group | Role | What they receive |
|---|---|---|
| mood disorders | Questionary and neuropsychological tasks will be administered Receives: Behavioral: questionary | |
| control | Questionary and neuropsychological tasks will be administered Receives: Behavioral: questionary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the scale of Crowded Racing Thoughts Questionary = (RCTQ scale that assesses the two forms of racing thoughts)
Demonstrated a two-factor structure (crowded and racing) assessment concurrent and discriminant validity.
Measured: one week
Secondary outcomes (1)
Evaluation of executive and temporal mechanisms involved in racing thoughts
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2019 (estimated)
- Study completionApr 2020 (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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Bertschy, PHDMD, Principal investigator, Les Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036606
- Sponsor's protocol ID
- 5582
- Status last verified
- Aug 2018
- First submitted
- 6 Jan 2014
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychopathological and Cognitive Mechanisms of Racing and Crowded Thoughts in Mood Disorders
- ClinicalTrials.gov ID
- NCT02036606
- Acronym / sponsor ID
- 5582
- Conditions
- Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 15 Jan 2014 (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.
Racing thoughts relate to subjective acceleration of thinking which has been essentially associated with manic episodes in bipolar disorder. Qualitatively, the phenomenology of racing thoughts in major depression seems to differ from rumination and pure manic racing thoughts: thoughts of all kinds accumulate in the patient's head. Recent qualitative evidence is consistent with the existence of these two kinds of "thought overactivity" related to mood disorders. In order to evaluate this and better understand the psychopathological and cognitive mechanisms that underlie thought overactivity in mood disorders, we have created a 34-item self-questionnaire - the Racing and Crowded Thoughts Questionnaire (RCTQ) and a number of neuropsychological tasks (time perception, cognitive flexibility). Also, given the relationship between mood disorders and creativity, it is likely that thought overactivity is related to increased creativity. We aim at evaluating this relationship through the French version of the Cognitive Processes Associated with Creativity scale (CPAC).
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mood disorders | – | Behavioral: questionaryQuestionary and neuropsychological tasks will be administered |
| control | – | Behavioral: questionaryQuestionary and neuropsychological tasks will be administered |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (2 listed)
- Bipolar disorder or depressive disorder
- 18 -65 years old
Key exclusion criteria (6 listed)
- neurological conditions or sequelae
- substance abuse in the last 10 months
- schizophrenia
- ADHD
- Borderline personality disorder
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 |
|---|---|---|
| questionary | Behavioural | control, mood disorders |
Primary outcome
Validation of the scale of Crowded Racing Thoughts Questionary = (RCTQ scale that assesses the two forms of racing thoughts)
Time frame: one week
Demonstrated a two-factor structure (crowded and racing) assessment concurrent and discriminant validity.
1 secondary outcome
Evaluation of executive and temporal mechanisms involved in racing thoughts
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
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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.
Dimitri Sanchez contact
Gilles Bertschy, PHDMD principal investigator
Les Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by University Hospital, Strasbourg, France 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 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 28 Aug 2018. 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 Dimitri Sanchez (drci@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the scale of Crowded Racing Thoughts Questionary = (RCTQ scale that assesses the two forms of racing thoughts) (time frame: one week). 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 28 Aug 2018.