Transcranial Magnetic Stimulation in Patients with Dual Disorders

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCardenal Herrera University

About this trial

According to the WHO, 280 million people are diagnosed with depression, the prevalence of which is almost twice as high in women as in men, with the incidence among young people increasing in recent years. Another public health problem in Spain is tobacco consumption, with one in four adults being tobacco users. The presence of an addiction and another mental illness in the same patient is called dual disorder, and it is very common for depression to be associated with smoking. This is due to a shared biopsychosocial vulnerability between the two disorders. Although there are currently pharmacological treatments that address both disorders, their efficacy is limited; in this sense, transcranial magnetic stimulation (TMS) offers a way to treat these dual disorders. TMS is a technique in which a magnetic field is applied to the cortex through a coil, generating an electric current that can induce changes in the different neurotransmitter systems, stimulating or inhibiting them. A randomised, double-blind, placebo-controlled clinical trial is proposed to evaluate the efficacy of TMS in the treatment of a sample of 36 patients with resistant major depression and nicotine dependence. Both depression and smoking will be assessed at baseline, at various times during treatment and at the end of the study using psychometric tests, neurophysiological and biochemical assessments. It is expected that the experimental group will show improvements in depression, nicotine dependence and certain cognitive functions. TMS treatment of dual disorders (resistant depression + smoking) could represent a health and social advance, especially for women.

Eligibility criteria

Qualifiers

Patients over 18 years of age being monitored in the mental health area of the province of Castellón, with a dual disorder: major depression and substance abuse disorder

Patients who are refractory to two or more lines of pharmacological treatments, ensuring correct completion beforehand

Acceptance of informed consent

Disqualifiers

Psychotic symptoms or catatonia

Other addictions, or psychiatric or personality disorders

Language barrier

Mental retardation that will interfere with the ability to understand and subsequent acceptance or rejection of informed consent

Trial design

Treatments tested in this trial

  • Repetitive Transcranial Magnetic Stimulation
  • Transcranial Magnetic Stimulation Sham

Treatment groups

36 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Cardenal Herrera University

Lead sponsor

Hospital Provincial de Castellon

Collaborator