DepressionPhase 4TMSFOSNCT02042573
Preliminary Study to Investigate the Effect of rTMS and SSRI Antidepressants on Leukocyte Expression of the C-FOS and DUSP1 Genes in Patients Treated for Depression
A Phase 4 study testing rTMS, SSRI (SEROPLEX ou ZOLOFT) and Genetic samples in people with Depression, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Low frequency rTMS (repetitive Transcranial Magnetic Stimulation) for the treatment of patients with depression, is responsible for a decrease in the expression of the C-FOS and DUSP1 genes in peripheral blood leukocytes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- rTMS, SSRI (SEROPLEX ou ZOLOFT) and Genetic samples
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2013to 5 Jun 2018
- Phase
- Phase 4
- 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
Who may be able to join
- Depressive patients to be treated with rTMS or SSRI:
- who have provided written informed consent
- who are covered by the national health insurance scheme
- who suffer from characterized depression (DSM-IV criteria) that is considered severe (Hamilton-17 item scale ≥ 19)
- who are aged 18-65 years,
- male or female
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- who have presented at least one failed treatment with medical antidepressants prescribed at an effective dosage for a duration of at least 6 weeks.
- Controls:
- Patients who have provided written informed consent
- who are covered by the national health insurance scheme
- aged between 18 and 65 years
- and either male or female
Who cannot join
- Depressive patients destined to benefit from treatment with rTMS or SSRI:
- Type I or II bipolar disorders
- Depression with characteristics of psychosis
- Schizophrenia
- Abuse of alcohol and/or illegal psycho-active substances.
- Dependence on alcohol and/or an illegal psycho-active substance.
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- Patients unable to provide consent to the protocol because of their mental disorders cannot be included in this study: patients with enforced psychiatric care (SDT, SDRE) or under ward of court.
- Contra-indication for rTMS; personal history of convulsions, pacemaker, neurosurgical clips, carotid or aortic clips, cardiac valves, audition prostheses, ventricular derivation valve, sutures with metallic thread or staples, foreign bodies in the eye, shrapnel, protheses or cephalic ferromagnetic implants, metal workers.
- Contra-indication for cerebral MRI
- Resistance to escitalopram or sertraline (prescription of escitalopram at 20 mg/d or sertraline at 50 mg/d for at least 6 weeks for the last episode)
- Contra-indication
- for escitalopram : Hypersensitivity to escitalopram or one of the excipients. non-selective and irreversible monoamine oxidase (IMAO) inhibitors, because of the risk of serotoninergic syndrome with agitation, trembling, hyperthermia. reversible MAO-A inhibitors (e.g.: moclobemide) or a non-selective reversible MAO inhibitor (linezolid), given the risk of a serotoninergic syndrome
- and to sertraline: Hypersensitivity to one of the components, Hypersensitivity to soja, Hypersensitivity to arachides, Treatment with IMAO
- Current pregnancy or breast-feeding: an assay for urinary beta-HCG will be done before inclusion in the protocol for women of child-bearing age.
- Contra-indication for escitalopram:
- Hypersensitivity to escitalopram or to one of the excipients. No-selective, irreversible monoamine oxidase (IMAO), because of the risk of serotoninergic syndrome with agitation, trembling and hyperthermia.
- Reversible MAO-A inhibitors (e.g.: moclobemide) or non-selective reversible MAO inhibitors (linezolid), because of the risk of serotoninergic syndrome.
- Patients presenting an acquired or congenital prolonged QT interval and patients on treatments known to prolong or suspected of prolonging the QT interval (list of treatments on azcert.org).
- Contra-indication to sertraline:
- Hypersensitivity to one of the components, Hypersensitivity to soja, Hypersensitivity to arachides, Treatment with IMAO. Patients treated with pimozide.
- Controls:
- Any current psychiatric disease or a history of psychiatric disease (defined by DSM-IV-TR criteria)
- Current addiction (except for occasional smoking) or a history of addiction (defined by DSM-IV-TR criteria)
- Any progressive somatic disease (cardiac, hepatic, renal, pulmonary…)
- Any pharmacological treatment with the exception of combined oral contraceptive pills
- Current pregnancy or breast-feeding: urinary beta-HCG will be assayed before inclusion in the protocol in women of child-bearing age.
- Personnel employed in the psychiatry and addictology department of Dijon CHU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TMSFOS: Preliminary Study to Investigate the Effect of rTMS and SSRI Antidepressants on Leukocyte Expression of the C-FOS and DUSP1 Genes in Patients Treated for Depression
Low frequency rTMS (repetitive Transcranial Magnetic Stimulation) for the treatment of patients with depression, is responsible for a decrease in the expression of the C-FOS and DUSP1 genes in peripheral blood leukocytes. The decrease in C-FOS expression could be explained by the inhibiting effect of low-frequency rTMS (in contrast, high-frequency rTMS causes activation of the cerebral cortex) [Rossi, 2009]. This genetic effect could correlate with the antidepressant effect [Hausmann, 2000].
According to this hypothesis, the genetic effect related to medical antidepressant treatments deserves to be studied because we could observe:
Read more
- either a decrease in the expression of the C-FOS and DUSP1 genes related to the antidepressant effect of the medical antidepressant treatment,
- or an increase in the expression of the C-FOS and DUSP1 genes related to cerebral activation due to the medical antidepressant treatment.
In summary, we wish to determine the validity of this hypothesis by comparing the genetic effect of rTMS with that of medical antidepressants to know if:
- this genetic effect is specific to rTMS or common rTMS and medical antidepressants
- this effect correlates with the clinical improvement induced by rTMS and by medical antidepressants
- this early modification in the C-FOS and DUSP1 genes may be predictor of the therapeutic response to rTMS and antidepressants (early decrease in gene expression)
- the absence of any decrease or increase in C-FOS and /or DUSP1 expression is a predictor of therapeutic resistance to rTMS and/or medical antidepressants.
- Conditions
- Depression
- Being tested
- rTMS, SSRI (SEROPLEX ou ZOLOFT), Genetic samples
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
SSRI (SEROPLEX ou ZOLOFT)Drug
Genetic samplesOther
| Study group | Role | What they receive |
|---|---|---|
| Depressive patients treated with rTMS | Other | Not described Receives: Device: rTMS; Other: Genetic samples |
| Depressive patients treated with SSRI | Other | Not described Receives: Drug: SSRI (SEROPLEX ou ZOLOFT); Other: Genetic samples |
| Controls | Other | Not described Receives: Other: Genetic samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukocyte expression of the C-FOS and DUSP1 genes
Measured: At 2, 4 and 8 weeks of treatment with rTMS or an SSRI antidepressant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study start25 Nov 2013
- Primary completion5 Jun 2018
Why it stopped: The study population is no longer accessible to the investigating team.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042573
- Sponsor's protocol ID
- TROJAK APJ 2012
- Acronym
- TMSFOS
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2014
- Last updated
- 21 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TMSFOS: Preliminary Study to Investigate the Effect of rTMS and SSRI Antidepressants on Leukocyte Expression of the C-FOS and DUSP1 Genes in Patients Treated for Depression
- ClinicalTrials.gov ID
- NCT02042573
- Acronym / sponsor ID
- TMSFOS / TROJAK APJ 2012
- Conditions
- Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study population is no longer accessible to the investigating team.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 25 Nov 2013 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- First posted
- 23 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.
Low frequency rTMS (repetitive Transcranial Magnetic Stimulation) for the treatment of patients with depression, is responsible for a decrease in the expression of the C-FOS and DUSP1 genes in peripheral blood leukocytes. The decrease in C-FOS expression could be explained by the inhibiting effect of low-frequency rTMS (in contrast, high-frequency rTMS causes activation of the cerebral cortex) [Rossi, 2009]. This genetic effect could correlate with the antidepressant effect [Hausmann, 2000].
According to this hypothesis, the genetic effect related to medical antidepressant treatments deserves to be studied because we could observe:
- either a decrease in the expression of the C-FOS and DUSP1 genes related to the antidepressant effect of the medical antidepressant treatment,
- or an increase in the expression of the C-FOS and DUSP1 genes related to cerebral activation due to the medical antidepressant treatment.
In summary, we wish to determine the validity of this hypothesis by comparing the genetic effect of rTMS with that of medical antidepressants to know if:
- this genetic effect is specific to rTMS or common rTMS and medical antidepressants
- this effect correlates with the clinical improvement induced by rTMS and by medical antidepressants
- this early modification in the C-FOS and DUSP1 genes may be predictor of the therapeutic response to rTMS and antidepressants (early decrease in gene expression)
- the absence of any decrease or increase in C-FOS and /or DUSP1 expression is a predictor of therapeutic resistance to rTMS and/or medical antidepressants.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Depressive patients treated with rTMS | Other | Device: rTMS, Other: Genetic samples |
| Depressive patients treated with SSRI | Other | Drug: SSRI (SEROPLEX ou ZOLOFT), Other: Genetic samples |
| Controls | Other | Other: Genetic samples |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- who have provided written informed consent
- who are covered by the national health insurance scheme
- who suffer from characterized depression (DSM-IV criteria) that is considered severe (Hamilton-17 item scale ≥ 19)
- who are aged 18-65 years,
- male or female
Key exclusion criteria (27 listed)
- Type I or II bipolar disorders
- Depression with characteristics of psychosis
- Schizophrenia
- Abuse of alcohol and/or illegal psycho-active substances.
- Dependence on alcohol and/or an illegal psycho-active substance.
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 |
|---|---|---|
| rTMS | Device | Depressive patients treated with rTMS |
| SSRI (SEROPLEX ou ZOLOFT) | Drug | Depressive patients treated with SSRI |
| Genetic samples | Other | Controls, Depressive patients treated with SSRI, Depressive patients treated with rTMS |
Primary outcome
Leukocyte expression of the C-FOS and DUSP1 genes
Time frame: At 2, 4 and 8 weeks of treatment with rTMS or an SSRI antidepressant
Results and safety
The study was stopped early (reason given: The study population is no longer accessible to the investigating team.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 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?
A Phase 4 study testing rTMS, SSRI (SEROPLEX ou ZOLOFT) and Genetic samples in people with Depression, run by Centre Hospitalier Universitaire Dijon 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 12 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: stopped early, as of the sponsor's last update on 21 Feb 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study population is no longer accessible to the investigating team.). 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?
Leukocyte expression of the C-FOS and DUSP1 genes (time frame: At 2, 4 and 8 weeks of treatment with rTMS or an SSRI antidepressant). 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 21 Feb 2024.