Depression and EpilepsyNCT03244345
Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies
A study testing Self-measurement scale of sensitivity to stress/emotion in people with Depression and Epilepsy, run by Assistance Publique Hopitaux De Marseille at 2 sites in France.
Trial summary
Psychiatric disturbances, notably depression, occur frequently as co-morbid conditions with epilepsy. A complex, probably bidirectional relationship between epilepsy and depression has been postulated. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression and Epilepsy
- What is being tested?
- Self-measurement scale of sensitivity to stress/emotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Feb 2017to 20 Feb 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Definite diagnosis of epilepsy, of any type (partial or generalised) and at any stage from diagnosis onwards
- Known or unknown etiology (symptomatic or cryptogenic epilepsy)
Who cannot join
- Psychogenic non-epileptic seizures
- Psychotic disorders and bipolar disorders
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13354
Aïleen Mc Gonigal, MD, aileen.mcgonigal@ap-hm.fr
- Not yet recruiting
Chu Tours
Tours
Bertrand DE TOFFOL, MD/PhD, bertrand.detoffol@univ-tours.fr
About this study
Psychiatric disturbances, notably depression, occur frequently as co-morbid conditions with epilepsy. A complex, probably bidirectional relationship between epilepsy and depression has been postulated. Both epilepsy and depression also interact with stressful life events, but only some patients develop these disorders after a stressful event, indicating the possibility of a "vulnerable" population. Animal and human studies have looked at the role of brain derived neurotrophic factor (BDNF) in this context. Low serum and/or CSF levels of BDNF are associated with higher incidence of depression, and thus indicate the vulnerable population.
Animal studies of BDNF have looked specifically at the relation between epilepsy and depression using a novel "double hit" design. After chronic stress exposure, measurement of BDNF levels allowed identification of 2 sub-groups: a vulnerable population and non-vulnerable population. A "second hit" of kainic acid induced status epilepticus (SE) was then applied to both the vulnerable and non-vulnerable populations. Only the vulnerable population exposed to SE developed a depression-like profile.
In a proof of concept approach we propose studying the relation between epilepsy, depression, anxiety and stressful life events, using serum BDNF levels in patients with pharmacoresistant epilepsy. Evaluation of epilepsy type and co-morbid psychiatric profile will be performed in 150 subjects. By comparing BDNF levels for different epilepsy subgroups to BDNF levels for healthy subjects and for depressed subjects without epilepsy, we hope to identify whether risk of co-morbid depression and/or anxiety in epilepsy may be predicted using BDNF levels. In addition, in a subgroup of 25 patients, we propose a pilot study in which cortisol and C-reactive protein will be measured in addition to BDNF.
- Conditions
- Depression and Epilepsy
- Being tested
- Self-measurement scale of sensitivity to stress/emotion
- Medical subject headings
- Depression, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-measurement scale of sensitivity to stress/emotionBehavioural
Patient will answer self-questionner on Depression
| Study group | Role | What they receive |
|---|---|---|
| Epileptic patient | Experimental | Not described Receives: Behavioral: Self-measurement scale of sensitivity to stress/emotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Score assessment of Becks Depression Inventory sacle
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 Aug 2017
- Study start20 Feb 2017
- Primary completion20 Feb 2020 (estimated)
- Study completion20 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression and EpilepsyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244345
- Sponsor's protocol ID
- 2016-19
- Other IDs
- 2016-A00708-43
- Status last verified
- Aug 2017
- First submitted
- 7 Aug 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies
- ClinicalTrials.gov ID
- NCT03244345
- Acronym / sponsor ID
- 2016-19
- Conditions
- Depression and Epilepsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 20 Feb 2020 (estimated)
- Study completion
- 20 Feb 2021 (estimated)
- First posted
- 9 Aug 2017 (actual)
- 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.
Psychiatric disturbances, notably depression, occur frequently as co-morbid conditions with epilepsy. A complex, probably bidirectional relationship between epilepsy and depression has been postulated. Both epilepsy and depression also interact with stressful life events, but only some patients develop these disorders after a stressful event, indicating the possibility of a "vulnerable" population. Animal and human studies have looked at the role of brain derived neurotrophic factor (BDNF) in this context. Low serum and/or CSF levels of BDNF are associated with higher incidence of depression, and thus indicate the vulnerable population.
Animal studies of BDNF have looked specifically at the relation between epilepsy and depression using a novel "double hit" design. After chronic stress exposure, measurement of BDNF levels allowed identification of 2 sub-groups: a vulnerable population and non-vulnerable population. A "second hit" of kainic acid induced status epilepticus (SE) was then applied to both the vulnerable and non-vulnerable populations. Only the vulnerable population exposed to SE developed a depression-like profile.
In a proof of concept approach we propose studying the relation between epilepsy, depression, anxiety and stressful life events, using serum BDNF levels in patients with pharmacoresistant epilepsy. Evaluation of epilepsy type and co-morbid psychiatric profile will be performed in 150 subjects. By comparing BDNF levels for different epilepsy subgroups to BDNF levels for healthy subjects and for depressed subjects without epilepsy, we hope to identify whether risk of co-morbid depression and/or anxiety in epilepsy may be predicted using BDNF levels. In addition, in a subgroup of 25 patients, we propose a pilot study in which cortisol and C-reactive protein will be measured in addition to BDNF.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epileptic patient | Experimental | Behavioral: Self-measurement scale of sensitivity to stress/emotion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Definite diagnosis of epilepsy, of any type (partial or generalised) and at any stage from diagnosis onwards
- Known or unknown etiology (symptomatic or cryptogenic epilepsy)
Key exclusion criteria (2 listed)
- Psychogenic non-epileptic seizures
- Psychotic disorders and bipolar 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 |
|---|---|---|
| Self-measurement scale of sensitivity to stress/emotionPatient will answer self-questionner on Depression | Behavioural | Epileptic patient |
Primary outcome
Depression
Time frame: 24 months
Score assessment of Becks Depression Inventory sacle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Depression and Epilepsy
Recruiting
Effect of Vagal Nerve Stimulation on Gastric Motor Functions
Depression, Epilepsy
Active, not recruiting
RESEARCH EVALUATING VAGAL EXCITATION AND ANATOMICAL LINKS
Epilepsy, Depressive Disorder
Active, not recruiting
Collaborative Care for Anxiety and Depression in Epilepsy
Epilepsy, Anxiety
Not yet recruitingPhase 2
Electrophysiologic Mechanisms of Ketamine Antidepressant Response
Epilepsy, Depressive Symptoms
RecruitingObservational study
Real-World Evidence in Patient-Reported Outcomes for Medical Cannabis (MC-RWE)
Pain, Sleep
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.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-measurement scale of sensitivity to stress/emotion in people with Depression and Epilepsy, run by Assistance Publique Hopitaux De Marseille at 2 sites 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 2 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 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Aïleen Mc Gonigal, MD (+33491384995, aileen.mcgonigal@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (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 9 Aug 2017.