Unipolar Depression
Conditions
Keywords
tDCS, mindulness, tES, electrotherapy, depression
Brief summary
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.
Interventions
DEVICEtranscranial direct current stimulation (tDCS) and mindfulness instruction
tDCS together with audio providing mindfulness instruction and music
DEVICESham tDCS and Mindfulness
Placebo electrical sitmulation and audio-guided mindfulness instruction
Sponsors
Soterix Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Any antidepressant medication is stable ≥ 30 days prior to HDRS-17 screening * Female patients are allowed if not pregnant and using a medically acceptable method of contraception, if of childbearing potential.
Exclusion criteria
* 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. * Failure to respond to ECT treatment or rTMS treatment in this or any previous episode. * Current DSM-V-TR psychotic disorder * History of clinically defined neurological disorder or insult that may impact participation in this study as determined by study physician * Metal in the cranium or skull defects * Implanted pump, neurostimulator, cardiac pacemaker or defibrillator * Skin lesions on scalp at the proposed electrode sites * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blinding Integrity | Week 7 | Participants will be asked to guess whether they received active or sham treatment, providing a third option of don't know |
| Hamilton Depression Rating Scale (HDRS) | Week 4 and Week 7 | Change in HDRS score from Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) | 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 13 | Safety outcome will be tested using the QIDS-SR through a web portal |
| Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF | 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 13 | Participants will enter responses to the Q-LES-Q-SF questionnaire through the web interface |
| Sheehan Disability Scale (SDS) | Baseline, Week 7, and Week 13 | Participants will be scored on the SDS at Baseline and at the end of the acute and maintenance phases. |
| Montgomery-Asburg Depression Rating Scale (MADRS) | Baseline, Week 7 and Week 13 | Trained clinical MADRS scores will be obtained at the end of the Acute phase and Maintenance phase. |
| Clinical Global Impression severity (CGI-S) and improvement (CGI-I) subscales | 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 13 | Participants will enter responses to the CGI-S and CGI-I questionnaires through the web interface |
| Response and Remission rates defined by HDRS | Week4, Week 7, Week 10, and Week 13 | Response rate, defined as a reduction in the HDRS score by 50% or more, and the remission rate, defined as an HDRS score ≤7. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event Questionnaire | 5 times per week for 7 weeks | 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) |
| Current Mood Score | 5 times per week for 7 weeks | 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 |
Countries
United States
Contacts
Primary ContactPaul Thomas Researcher
Outcome results
None listed