Major Depressive Disorder Mood Disorders
Conditions
Interventions
This is a randomized, active-controlled, non-inferiority clinical trial with two parallel arms, single-blind design, and a one-on-one allocation ratio. Thirty-nine adult participants diagnosed with de
thirty-minute duration
thirty-five cm² saline-soaked sponge electrodes
anodal placement over the left dorsolateral prefrontal cortex at the F three position of the ten-twenty system and cathodal placement over the right dorsolateral prefrontal cortex at the F four positi
Sponsors
Universidade Católica de Brasília (UCB) — Programa de Pós-Graduação Stricto Sensu em Psicologia
Universidade Católica de Brasília (UCB) — Programa de Pós-Graduação Stricto Sensu em Psicologia
Universidade Federal de Rondônia (UNIR) - Comissão de Ética
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: The following participants will be included in the study: users of the Centro de Atenção Psicossocial (Psychosocial Care Center) located in the municipality of Vilhena, in the State of Rondônia, diagnosed with depression; participants must present a recent medical report, from the last sixty days, issued by a psychiatrist or by a neurologist, attesting depression and the absence of neurological problems or cerebral deformations that prevent the use of neuromodulation devices; participants must be between eighteen and sixty years of age; present scores indicative of depression at the initial assessment of the study; present a minimum profile compatible with Behavioral Activation, based on initial assessment in which the following will be observed: the individual's willingness to engage and participate in activities proposed at the Centro de Atenção Psicossocial de Vilhena (Psychosocial Care Center of Vilhena); the ability to identify potentially pleasurable or rewarding activities; the ability to set and work toward goals; the flexibility to adjust behaviors as necessary; and the motivation to overcome the initial inertia frequently associated with depression.
Exclusion criteria
Exclusion criteria: The following will be excluded from the study: current use of psychotropic medication, including antidepressants, or recent initiation of pharmacological treatment, that is, participants who have used such medications must have completed, by their own initiative and responsibility, the medication discontinuation process before the start of the study, ensuring the absence of residual effects of the medications; presence of psychiatric or neurological comorbidities, such as schizophrenia, schizoaffective disorder, bipolar disorder, obsessive-compulsive disorder, attention deficit hyperactivity disorder, personality disorders, substance dependence and substance abuse disorders, epilepsy, or history of seizures; presence of cranial problems or of metallic devices inside or around the brain, such as brain surgery clips, cranial plates or screws, cochlear implants, use of brain pacemakers, that is, deep brain stimulation devices, body implants such as cardiac pacemakers, cochlear implants, spinal cord stimulators, vagus nerve stimulators, implanted hearing aids, or defibrillators; skin problems that affect the electrode placement region, such as psoriasis, redness, cuts, or infections; history of suicidal ideation with planning or suicide attempt in the twelve weeks prior to the start of the research; previous care at the Centro de Atenção Psicossocial de Vilhena (Psychosocial Care Center of Vilhena) due to a depressive condition with treatment abandonment in the last two years; and, for female participants, those who are pregnant, or who present postpartum depression, or who are breastfeeding will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: It is expected to find a clinical antidepressant response, defined as a reduction of at least fifty percent in the total score, verified by means of the Hamilton Depression Rating Scale in its seventeen-item version applied at Baseline and at the end of the intervention, from the verification of non-inferiority of the combined treatment (active Transcranial Direct Current Stimulation combined with the Behavioral Activation of the Instituto de Análise do Comportamento de Curitiba) in relation to the isolated treatment (placebo Transcranial Direct Current Stimulation combined with the same Behavioral Activation of the Instituto de Análise do Comportamento de Curitiba), by means of analysis of covariance controlling for the Baseline score.;Observed outcome 1: A clinical response of one hundred percent was observed in the experimental group and seventy percent in the control group, verified by means of the Hamilton Depression Rating Scale in its seventeen-item version, with an adjusted difference by analysis of covariance of seven point forty-four points (ninety-five percent confidence interval from two point eighty-six to twelve point zero one) and a p-value of zero point zero twenty in Fisher's exact test, confirming the pre-specified non-inferiority hypothesis and establishing clinical superiority of the combined treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Observed outcome 4: Maintenance of antidepressant therapeutic effects was observed in twenty-seven participants from the first three cohorts recruited, verified by means of the Hamilton Depression Rating Scale in its seventeen-item version and the Montgomery and Asberg Depression Rating Scale, with more consistent maintenance among participants in the experimental group compared to participants in the control group.;Expected outcome 2: It is expected to find a higher clinical remission rate in the experimental group compared to the control group, verified by means of the Hamilton Depression Rating Scale in its seventeen-item version applied at the end of the intervention, from the verification of a total score less than or equal to seven points.;Observed outcome 2: A clinical remission rate of ninety percent was observed in the experimental group and fifty percent in the control group, verified by means of the Hamilton Depression Rating Scale in its seventeen-item version, with a p-value of zero point zero fourteen in Fisher's exact test and an odds ratio of nine point zero (ninety-five percent confidence interval from one point sixty-seven to forty-eight point forty-one).;Expected outcome 3: It is expected to find a more pronounced dimensional reduction of depressive symptoms in the experimental group compared to the control group, verified by means of the Beck Depression Inventory in its second edition, the Montgomery and Asberg Depression Rating Scale, and the Depression Subscale of the Depression, Anxiety and Stress Scale with twenty-one items, applied at Baseline and at the end of the intervention, from the verification of absolute reduction in the total scores.;Observed outcome 3: A more pronounced dimensional reduction of depressive symptoms was observed in the experimental group on all three secondary instruments, with a reduction of sixty-three point three percent on the Beck Depression Inventory in its second edition, a reduction of eighty-three point | — |
Countries
BR
Contacts
Public ContactMarcelo Marinho
Universidade Católica de Brasília (UCB) — Programa de Pós-Graduação Stricto Sensu em Psicologia
Outcome results
None listed