Transcranial Direct Current Stimulation for Depression
ConditionUnipolar Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorSoterix Medical
About this trial
This study will test the efficacy of transcranial direct current stimulation (tDCS) combined with mindfulness, remotely-delivered using a telemedicine protocol in 25 adults with unipolar depression.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinically stable patients that meet criteria for diagnosis of MDD according to DSM-V-TR and confirmed with the Mini International Neuropsychiatric interview
Currently experiencing a major depressive episode of at least 4 week's duration as part of a unipolar depression
QIDS-SR score >11 on all three days of screening week (Days 1,3, 7)
Scored at least 17 (inclusive) on the HDRS-17 at trial entry
Disqualifiers
Failure to respond to at least 2 antidepressant medications
Drug or alcohol abuse or dependence in the preceding 3 months
Concurrent benzodiazepine medication
High suicide risk assessed during clinician screening at baseline interview.
Trial design
Design model
Parallel
Treatments tested in this trial
transcranial direct current stimulation (tDCS) and mindfulness instruction
DevicetDCS together with audio providing mindfulness instruction and music
Sham tDCS and Mindfulness
DevicePlacebo electrical sitmulation and audio-guided mindfulness instruction
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Active tDCS and MindfulnessExperimental treatment 1 intervention
Group B: Sham tDCS and MindfulnessSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hamilton Depression Rating Scale (HDRS)
Change in HDRS score from Baseline
Time frame
Week 4 and Week 72
Blinding Integrity
Participants will be asked to guess whether they received active or sham treatment, providing a third option of "don't know"
Time frame
Week 7Secondary outcomes
1
Response and Remission rates defined by HDRS
Response rate, defined as a reduction in the HDRS score by 50% or more, and the remission rate, defined as an HDRS score ≤7.
Time frame
Week4, Week 7, Week 10, and Week 132
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR)
Safety outcome will be tested using the QIDS-SR through a web portal
Time frame
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 133
Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF
Participants will enter responses to the Q-LES-Q-SF questionnaire through the web interface
Time frame
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 134
Clinical Global Impression severity (CGI-S) and improvement (CGI-I) subscales
Participants will enter responses to the CGI-S and CGI-I questionnaires through the web interface
Time frame
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13Other outcomes
1
Adverse Event Questionnaire
Participants will report any side effects experienced, their severity (mild, moderate, severe), pain scores based on the Wong-Baker pain scale, and temporal relationship with the tDCS session (before, during, after)
Time frame
5 times per week for 7 weeks2
Current Mood Score
Participants will enter a daily mood score on a scale of 0-10 (0= feeling normal and not depressed at all and 10= feeling as depressed as they possibly could be) on the web interface
Time frame
5 times per week for 7 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov