Clinical trial NCT05694754: Transcranial Magnetic Stimulation Theta Burst (TMS), Depression and Smoking.
Official title: Transcranial Magnetic Stimulation and Its Effects on Mayor Depressive Disorder and Smoking Cessation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Smoking Reduction
Keywords: Transcranial magnetic stimulation
Theta Burst
Depression
Tobacco
suicide ideation
Lead sponsor: Universidad Autonoma de Queretaro
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates de efficacy of Theta Burst Transcranial Magnetic Stimulation (TMS) applied on the left dorsolateral prefrontal cortex in patients with Major Depressive disorder and tobacco consumption.

Detailed description: Major Depressive Disorder (MDD) affects 350 million worldwide causing damage on quality of life and risk behavior such as suicide and smoking. smoking is the second leading cause of death causing about 5 million deaths annually. Theta Burst Stimulation (TBS) is a more tolerable protocol administered at lower intensities and shorter intervals than conventional rTMS protocols.

Eligibility criteria: Inclusion Criteria:

* With dependence on tobacco use, with depressive symptomatology, that they agree to sign the informed consent letter.

Exclusion Criteria:

* History of head trauma with loss of consciousness, with intracranial metallic objects or metallic plates in the skull, patients with structured suicidal ideation or recent attempts, who suffer from uncontrolled chronic diseases at the time of entering the study (for example: hypertension, diabetes, rheumatic diseases), patients with psychotic symptoms. subjects with alterations in electroencephalogram (epileptiform activity), patients with any type of uncontrolled chronic medical or neurological disease, pregnant women.

Primary outcomes:
measure: MINI Neuropsychiatric Interview
timeFrame: 15 minutes
measure: Fagerström test
timeFrame: 5 minutes
measure: Richmond Test
timeFrame: 5 minutes
measure: Glover-Nilsson Test
timeFrame: 8 minutes
measure: Test of the Unit of the Institute of Public Health of Madrid (UISPM)
timeFrame: 10 minutes
measure: Minnesota Nicotine Withdrawal Syndrome Scale (MNWS)
timeFrame: 5 minutes
measure: Nicotine Craving Questionnaire (CCN)
timeFrame: 8 minutes
measure: Paradigm of reactivity to signals and heart rate variability
timeFrame: 10 minutes
measure: Co-oximetry
timeFrame: 1 minute
measure: Hamilton Rating Depression Scale (HDRS)
timeFrame: 10 minutes
measure: Montgomery-Asberg Rating Depression Scale (MADRS)
timeFrame: 10 minutes
measure: Hamilton Anxiety Rating Scale (HARS)
timeFrame: 10 minutes
measure: Beck Depression Invetory (BDI)
timeFrame: 10 minutes
measure: Beck Hopelesness Scale (BHS)
timeFrame: 10 minutes
measure: Plutchik Risk Suicide Scale
timeFrame: 10 minutes
measure: Beck suicidal ideation scale (BSIS)
timeFrame: 10 minutes
measure: Wisconsin Card Sorting Test (WCST)
timeFrame: 20 minutes
measure: Stop Signal Task
timeFrame: 25 minutes
Secondary outcomes:
measure: Marlowe and Crowne Social Desirability Scale
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Querétaro City
country: Mexico
facility: Sofia Cañizares Gómez
state: Querétaro
Study officials:
affiliation: Universidad Autónoma de Querétaro
name: Julian V. Reyes López, PhD
role: STUDY_DIRECTOR
References:
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citation: Arikan MK, Gunver MG, Tarhan N, Metin B. High-Gamma: A biological marker for suicide attempt in patients with depression. J Affect Disord. 2019 Jul 1;254:1-6. doi: 10.1016/j.jad.2019.05.007. Epub 2019 May 6.
citation: Mahoney JJ 3rd, Hanlon CA, Marshalek PJ, Rezai AR, Krinke L. Transcranial magnetic stimulation, deep brain stimulation, and other forms of neuromodulation for substance use disorders: Review of modalities and implications for treatment. J Neurol Sci. 2020 Nov 15;418:117149. doi: 10.1016/j.jns.2020.117149. Epub 2020 Sep 20.
citation: Filipcic I, Milovac Z, Sucic S, Gajsak T, Filipcic IS, Ivezic E, Aljinovic V, Orgulan I, Penic SZ, Bajic Z. Efficacy, Safety and Tolerability of Augmentative rTMS in Treatment of Major Depressive Disorder (MDD): A Prospective Cohort Study in Croatia. Psychiatr Danub. 2017 Mar;29(1):31-38. doi: 10.24869/psyd.2017.31.
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