Major Depressive Disorder (MDD)CONHECTNCT06661616
Cognitive Effects Associated With Hippocampal Neurogenesis Induced by ECT in the Treatment of Depression
An observational study of Major Depressive Disorder (MDD) and Bipolar Disorder Depression, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
Electroconvulsive therapy (ECT) is the treatment of choice for drug-resistant depression (30% of patients), or when there is a short-term risk to the patient's life. Despite its robust efficacy and rapid onset of action, its use is limited both by the limited range of treatment available and by the cognitive effects… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder (MDD), Bipolar Disorder Depression
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2018to 14 May 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study focuses on a population of adult patients suffering from unipolar or bipolar depression and treated with electroconvulsive therapy. In order to monitor the impact of depression on cognitive functions, including memory, and on biological markers and brain imaging, 35 depressed subjects treated without ECT will be recruited. And to monitor the effect of time on memory, 35 healthy volunteers will be recruited.
Who may be able to join
- Study population: depressed subjects treated with ECT
- Male or female over 18 years of age
- Hospitalised at the Centre Hospitalier Sainte-Anne
- Suffering from a unipolar or bipolar major depressive episode, according to DSM5 criteria
- Indication for ECT treatment
- Patient has given informed written consent
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- Beneficiary of a social security scheme
- Control population: depressed subjects treated without ECT
- Male or female over 18 years of age
- Hospitalised at the Centre Hospitalier Sainte-Anne
- Suffering from a unipolar or bipolar major depressive episode, according to DSM5 criteria
- Patient who has given informed written consent
- Beneficiary of a social security scheme
- Control population: healthy volunteers
- Male or female over 18 years of age
- Patient with written informed consent
- Beneficiary of a social security scheme
Who cannot join
- Study population: depressed subjects with ECT
- Psychiatric comorbidity: schizophrenia, pervasive developmental disorder, dependence on a substance other than tobacco
- Neurological comorbidity: Parkinson's disease, dementia
- ECT treatment in the 6 months prior to inclusion
- Compulsory care
- Protected adults, persons under court protection measures
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- Persons deprived of liberty by judicial or administrative decision;
- Refusal of consent to ECT treatment
- Contraindications to ECT (HTIC, recent history of stroke, severe uncontrolled arterial hypertension, contraindication to anaesthesia)
- Contraindications to MRI (patients with metal prostheses, claustrophobia)
- Pregnant or breast-feeding women
- Control population: depressed subjects without ECT
- Psychiatric comorbidity: schizophrenia, pervasive developmental disorder, dependence on any substance other than tobacco
- Neurological comorbidity: Parkinson's disease, dementia
- ECT treatment in the 6 months prior to inclusion
- Compulsory care
- Protected adults, persons under court protection measures
- Persons deprived of liberty by judicial or administrative decision;
- Pregnant or breast-feeding women
- Control population: healthyvolunteers
- Protected adults, persons under legal protection,
- Persons deprived of their liberty by judicial or administrative decision ;
- persons hospitalised for purposes other than research
- Clear psychiatric history
- Dependence on any substance other than tobacco
- Neurological history: Parkinson's disease, dementia
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
France1 site
Sainte-Anne Hospital (GHU Paris Psychiatrie et Neurosciences)
Paris, 75014
About this study
Official title: Cognitive Effects Associated With Hippocampal Neurogenesis Induced by Electroconvulsive Therapy in the Treatment of Depression
Electroconvulsive therapy (ECT) is the treatment of choice for drug-resistant depression (30% of patients), or when there is a short-term risk to the patient's life. Despite its robust efficacy and rapid onset of action, its use is limited both by the limited range of treatment available and by the cognitive effects sometimes induced. The present study focuses on the links between the efficacy of ECT, its cognitive effects and the formation of new neurons in the hippocampus (hippocampal neurogenesis) associated with this treatment.
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Depressed patient treated with electroconvulsivotherapy | The indication for ECT treatment is established by the department's medical team. Participants are not assigned to ECT as part of this observational study. | |
| Depressed patient treated without electroconvulsivotherapy | The indication for antidepressant treatment is established by the department's medical team. Participants are not assigned to ECT as part of this observational study. | |
| Healthy volunteers | Age- and sex-matched healthy volunteers free of psychiatric disorders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between increased hippocampal volume and post-ECT retrograde amnesia
Measured: After a course of ECT, 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 posted28 Oct 2024
- Study start6 Jun 2018
- Primary completion14 May 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661616
- Sponsor's protocol ID
- D17-P018
- Acronym
- CONHECT
- Status last verified
- Sep 2024
- First submitted
- 24 Oct 2024
- Last updated
- 28 Oct 2024
- 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 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Effects Associated With Hippocampal Neurogenesis Induced by Electroconvulsive Therapy in the Treatment of Depression
- ClinicalTrials.gov ID
- NCT06661616
- Acronym / sponsor ID
- CONHECT / D17-P018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 28 Oct 2024 (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.
Electroconvulsive therapy (ECT) is the treatment of choice for drug-resistant depression (30% of patients), or when there is a short-term risk to the patient's life. Despite its robust efficacy and rapid onset of action, its use is limited both by the limited range of treatment available and by the cognitive effects sometimes induced. The present study focuses on the links between the efficacy of ECT, its cognitive effects and the formation of new neurons in the hippocampus (hippocampal neurogenesis) associated with this treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Depressed patient treated with electroconvulsivotherapy | – | –The indication for ECT treatment is established by the department's medical team. Participants are not assigned to ECT as part of this observational study. |
| Depressed patient treated without electroconvulsivotherapy | – | –The indication for antidepressant treatment is established by the department's medical team. Participants are not assigned to ECT as part of this observational study. |
| Healthy volunteers | – | –Age- and sex-matched healthy volunteers free of psychiatric disorders. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study focuses on a population of adult patients suffering from unipolar or bipolar depression and treated with electroconvulsive therapy. In order to monitor the impact of depression on cognitive functions, including memory, and on biological markers and brain imaging, 35 depressed subjects treated without ECT will be recruited. And to monitor the effect of time on memory, 35 healthy volunteers will be recruited.
Key inclusion criteria (17 listed)
- Study population: depressed subjects treated with ECT
- Control population: depressed subjects treated without ECT
- Control population: healthy volunteers
Key exclusion criteria (27 listed)
- Study population: depressed subjects with ECT
- Control population: depressed subjects without ECT
- Control population: healthyvolunteers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between increased hippocampal volume and post-ECT retrograde amnesia
Time frame: After a course of ECT, up to 3 months
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 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Major Depressive Disorder (MDD) and Bipolar Disorder Depression, run by Centre Hospitalier St Anne 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 17 inclusion and 27 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 Oct 2024. 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?
Correlation between increased hippocampal volume and post-ECT retrograde amnesia (time frame: After a course of ECT, up to 3 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 28 Oct 2024.