Status:
COMPLETED
Portable Transcranial Electrical Stimulation and Internet-Based Behavioral Therapy for Major Depression Study
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Major Depressive Disorder
Unipolar Depression
Eligibility:
All Genders
18-59 years
Phase:
NA
Brief Summary
First-line treatments for major depressive disorder (MDD), antidepressants and psychotherapy, are associated with refractoriness and discontinuation due to side effects, and logistical burdens, respec...
Detailed Description
Major depressive disorder (MDD) is a prevalent, debilitating and chronic mental disorder, characterized by frequent recurrences and resistance to first-line treatments: antidepressants and onsite cogn...
Eligibility Criteria
Inclusion
- Diagnosis of major depressive disorder (MDD) per DSM-5 criteria
- Hamilton Rating Scale (17-item version)-HDRS score ≥ 17 at baseline
- Years of education ≥ 8
- Having access to a smartphone with internet access at home
- Treatment refractoriness ≤ 3 antidepressants, at optimal doses and for appropriate duration
- No contraindications for tDCS (i.e., metallic plates on the head, brain devices, cochlear implants, cardiac pacemakers)
- No suicidal ideation with planning, or attempted suicide, in the 4 weeks prior to baseline
Exclusion
- Other psychiatric diagnoses (i.e., schizophrenia, schizoaffective disorder, bipolar disorder, obsessive compulsive disorder, attention-deficit and hyperactivity disorder, personality disorders, substance dependence and/or abuse disorders). Obs.: Anxiety disorders, as a comorbidity, will not be an exclusion criterium.
- Suspected or confirmed pregnancy
- Lactation
- Severe clinical or neurological conditions, including Post-Acute Sequelae of COVID-19
- Depressive symptoms better explained by other clinical conditions (i.e., hypothyroidism, anemia) or other psychiatric disorders.
- Use of benzodiazepines \> 10mg diazepam or diazepam-equivalent per day
Key Trial Info
Start Date :
May 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2022
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04889976
Start Date
May 22 2021
End Date
October 21 2022
Last Update
November 1 2022
Active Locations (2)
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1
Institute of Psychiatry, HC-FMUSP
São Paulo, São Paulo, Brazil
2
Hospital Universitário - USP
São Paulo, Brazil, 05508000