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 (TMSFOS)

February 20, 2024 updated by: Centre Hospitalier Universitaire Dijon

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:

  • 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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Dijon, France, 21079
        • CHU de Dijon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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
  • 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

Exclusion Criteria:

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.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Depressive patients treated with rTMS
Device: rTMS
Other: Genetic samples
Other: Depressive patients treated with SSRI
Other: Genetic samples
Drug: SSRI (SEROPLEX ou ZOLOFT)
Other: Controls
Other: Genetic samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At 2, 4 and 8 weeks of treatment with rTMS or an SSRI antidepressant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2013

Primary Completion (Actual)

June 5, 2018

Study Registration Dates

First Submitted

January 17, 2014

First Submitted That Met QC Criteria

January 20, 2014

First Posted (Estimated)

January 23, 2014

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TROJAK APJ 2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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