NCT06765824Not yet recruitingPhase 3
Transcranial Magnetic Stimulation in Patients with Dual Disorders
Transcranial Magnetic Stimulation in the Treatment of Dual Disorders: Study in Patients with Depression and Tobacco Addiction
Source: ClinicalTrials.gov · Last updated 9 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 18 Dec 2024
- Start date
- Feb 2025
- Primary completion date
- Feb 2026
- Lead sponsor
- Cardenal Herrera University
- Diseases
- Depression
- NCT number
- NCT06765824
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 36
- From Feb 2025 to the primary completion date, Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other addictions, or psychiatric or personality disorders
- Patients diagnosed with epilepsy
Other
- Psychotic symptoms or catatonia
- Language barrier
- Mental retardation that will interfere with the ability to understand and subsequent acceptance or rejection of informed consent
- Patients diagnosed with a space-occupying lesion in the brain
- Tinnitus
- Confirmed pregnancy; if suspected, a test will be requested
- Metal piece in the body or implanted medical device, except for dental material
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Consorcio Hospitalario Provincial de Castellon Coordinator of this site? Confirm its status | Castellon | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.