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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Repetitive Transcranial Magnetic Stimulation
Device
The protocol will be applied with the MagVenture R30 stimulation device and the cool-B70 coil for active treatment. The protocol will consist of two sessions per day, with a 50-minute break between sessions, every day of the week (Monday to Friday) for three and a half weeks (a total of 36 sessions). Each session will consist of the application of a 1Hz protocol (2000 pulses at 120% of the motor threshold) in the right dorsolateral prefrontal cortex (F4) followed by an intermittent theta-burst protocol (1800 pulses at 90% of the motor threshold) in the left dorsolateral prefrontal cortex (F3). The cortical target localization will be performed using the beam-F3/F4 technique that combines different electroencephalographic positioning parameters and measurements to accurately locate said cortical targets. The motor threshold of each patient will be calculated at the beginning of each week of treatment using an electromyography system.
Transcranial Magnetic Stimulation Sham
Device
The same protocol described in the intervention group will be carried out in the control group. The device used is the same, the difference is the coil that maintains the same appearance and generates the same sound as the active treatment coil, but unlike the latter, it does not produce an effective magnetization to depolarize the cerebral cortex on which we act.

Treatment groups

36 Participants

are divided into 2 treatment groups

Group A: Transcranial Magnetic Stimulation-Active CoilExperimental treatment 1 intervention

Group B: Transcranial Magnetic Stimulation-Sham coilSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of transcranial magnetic stimulation in the treatment of resistant major depression and smoking, in patients with dual diagnosis..

The tolerability of the treatment will be measured by means of a qualitative questionnaire (YES/NO), to be filled out by the patient. The possible side effects that will be taken into account are: epileptic crisis, manic shift, syncope, transient headache, localized pain in the area of application, neck pain, paresthesia, toothache, transient changes in hearing and scalp burns.

Time frame

Baseline and day 5, 10, 15 and 18. Baseline and day 108 (booster doses completed).

2

Evaluation of the efficacy of transcranial magnetic stimulation in the treatment of resistant major depression in patients with dual disorder through the Hamilton Rating Scale.

The effectiveness of the treatment applied will be through the evaluation of the changes produced in the affective symptoms. These changes will be evaluated with the following clinical scales: \- Hamilton Rating Scale for Depression (HDRS). Classification of symptoms: 0 - absent; 1 - mild; 2 - moderate; 3 - severe; 4 - incapacitating. In general the higher the total score the more severe the depression. HAM-D score level of depression: 10 - 13 mild; 14-17 mild to moderate; \>17 moderate to severe.

Time frame

Baseline. Baseline and day 9 and 18. Baseline and day 108 (booster doses completed).

3

Evaluation of the efficacy of transcranial magnetic stimulation in the treatment of resistant major depression in patients with dual disorder through Clinical Global Impression Scale.

The effectiveness of the treatment applied will be through the evaluation of the changes produced in the affective symptoms. These changes will be evaluated with the following clinical scales: -Clinical Global Impression (CGI) The scale consists of two sections: severity of the disease and improvement. Scores range from 1 to 7. Higher scores correspond to more severe symptoms and no improvement. A score of 0 corresponds to no evaluation.

Time frame

Baseline. Baseline and day 9 and 18. Baseline and day 108 (booster doses completed)

4

Evaluation of the efficacy of transcranial magnetic stimulation in the treatment of resistant major depression and smoking in patients with dual disorder.

The effectiveness of the treatment applied will be through the evaluation of the changes produced in the affective symptoms. These changes will be evaluated with the following clinical scales: \- Montgomery-Asberg Depression Rating Scale (MADRS) It is a 10-item scale. For each item, the scale includes 7 levels of intensity/severity, scored from 0 to 6, of which 4 (0-2-4-6) are predefined and the remaining 3 (1-3-5) are reserved for intermediate situations in which it is not possible to clearly assign the degree of symptomatic intensity to any of the previous levels. A score below 10 points is considered to indicate the absence of depressive disorder.

Time frame

Baseline. Baseline and day 9 and 18. Baseline and 3 months (booster doses completed)

Secondary outcomes

1

Detection by clinical scales of changes produced in different cognitive functions after treatment with transcranial magnetic stimulation in patients with dual diagnosis (resistant major depression and smoking).

Cognitive functions will be assessed using: \- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) The RBANS assesses immediate memory, spatial skills, language, attention, and delayed recall. There are no absolute values, the average is between 85 and 115. Obtaining scores below 70 will indicate significant cognitive deficits.

Time frame

Baseline. Baseline and day 9 and 18. Baseline and day 108 (booster doses completed)

2

Detection by clinical scales of changes produced in different cognitive functions after treatment with transcranial magnetic stimulation in patients with dual diagnosis (resistant major depression and smoking).

Cognitive functions will be assessed using: -Clock Drawing Test (CDT). Scores range from 10 to 0. High scores (e.g., 9-10): Generally indicate good cognitive functioning and normal task performance. Low scores (e.g., 3 or less): May be indicative of cognitive dysfunction

Time frame

Baseline. Baseline and day 9 and 18. Baseline and day 108 (booster doses completed)

3

Detection by neurophysiological tests of changes produced in different cognitive functions after treatment with transcranial magnetic stimulation in patients with dual diagnosis (resistant major depression and smoking).

Neurophysiological tests will be: \- Cognitive potentials (P300 wave). In the P300 wave potential, the parameter evaluated is the latency at which the wave is objectified, which should be between 300-600 ms.

Time frame

Baseline. Baseline and day 9 and 18. Baseline and 3 months (booster doses completed)

4

Detection by neurophysiological tests of changes produced in different cognitive functions after treatment with transcranial magnetic stimulation in patients with dual diagnosis (resistant major depression and smoking).

Neurophysiological tests will be: \- Quantified electroencephalogram (Q-EEG): Examination of the different frequency bands and the power of each: * alpha * beta * delta * theta

Time frame

Baseline. Baseline and day 9 and 18. Baseline and day 108 (booster doses completed)

Transcranial Magnetic Stimulation in Patients with Dual Disorders

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts