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

NCT02042573 | Terminated Phase 4

• 1 other identifier: TROJAK APJ 2012
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Leukocyte expression of the C-FOS and DUSP1 genes

  At 2, 4 and 8 weeks of treatment with rTMS or an SSRI antidepressant

Study Arms (3)

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

Interventions

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU de Dijon

Dijon, 21079, France

Location

MeSH Terms

Conditions

Depression

Interventions

Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 23, 2014
• Study Start: November 25, 2013
• Primary Completion: June 5, 2018
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

FR (1)