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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)

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ClinicalTrials.gov Identifier: NCT02042573
Recruitment Status : Unknown
Verified January 2013 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : January 23, 2014
Last Update Posted : January 23, 2014
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Tracking Information
First Submitted Date  ICMJE January 17, 2014
First Posted Date  ICMJE January 23, 2014
Last Update Posted Date January 23, 2014
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Depression
Intervention  ICMJE
  • Device: rTMS
  • Drug: SSRI (SEROPLEX ou ZOLOFT)
  • Other: Genetic samples
Study Arms  ICMJE
  • Depressive patients treated with rTMS
    Interventions:
    • Device: rTMS
    • Other: Genetic samples
  • Depressive patients treated with SSRI
    Interventions:
    • Drug: SSRI (SEROPLEX ou ZOLOFT)
    • Other: Genetic samples
  • Controls
    Intervention: Other: Genetic samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 20, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02042573
Other Study ID Numbers  ICMJE TROJAK APJ 2012
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire Dijon
Study Sponsor  ICMJE Centre Hospitalier Universitaire Dijon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP