Major Depressive DisorderPhase 1/2SPIDEPNCT03433339
Spinal Cord Stimulation for the Treatment of Major Depressive Disorder
A Phase 1/2 study testing Active transcutaneous spinal direct current stimulation in people with Major Depressive Disorder, run by University of Cincinnati at 1 site in United States.
Trial summary
This pilot clinical trial will evaluate the efficacy and safety of transcutaneous direct current stimulation (tsDCS) in major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Active transcutaneous spinal direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2018to 13 Sep 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18-55 yrs., inclusive
- female or male
- Body mass index (BMI) 18.5 to 35 kg/mts2, inclusive
- current MDD episode diagnoses confirmed by Mini International Neuropsychiatric Interview (MINI) 5.0 with a duration of ≥1 month and ≤24 months
- moderate MDD symptoms according to Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20 to ≤35
- no current or recent (past month) antidepressant pharmacological treatment
- Generalized anxiety disorder (GAD) and other anxiety symptoms will be permitted
- using an effective contraceptive method (all participants of childbearing potential).
Who cannot join
- Current or lifetime MDD episode non-responsive to two or more antidepressant treatments at adequate doses and time (including ECT)
- Current or lifetime bipolar disorder or schizophrenia diagnosis
- current (past month): PTSD, psychotic or substance use disorder (nicotine and caffeine allowed)
- significant risk of suicide according to Columbia Suicide Severity Rating Scale (CSSRS) or clinical judgment, or suicidal behavior in the past year
- current chronic severe pain conditions
- current chronic use of: opioids analgesics, medications that affect blood pressure or drugs with significant autonomic effects (stimulants and antipsychotics allowed if dose stable for 1 month)
Show all 12Show fewer
- neurological, endocrinological, cardiovascular (including diagnosed hypertension) or other clinically significant medical conditions as judged by the clinician
- skin lesions on electrode placement region
- implanted electrical medical devices
- Pregnancy
- suspected Intellectual quotient (IQ)<80
- any other clinically relevant reason as judged by the clinician.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lindner Center of HOPE/University of Cincinnati
Mason, Ohio, 45040
About this study
This pilot clinical trial will evaluate the efficacy and safety of transcutaneous direct current stimulation (tsDCS) in major depressive disorder.
Read the detailed description
This study aims to 1) determine the efficacy and safety of tsDCS in adult patients with major depressive disorder (MDD) and 2) investigate interoceptive awareness, somatic symptoms, autonomic and metabolic regulation as potential mediators of antidepressant response to tsDCS. We predict that 1) Active tsDCS treatment will result in a greater decrease in depressive symptom severity compared to Sham tsDCS in adult patients with MDD, 2) active tsDCS will be safe and well tolerated in adult patients with MDD and 3) change in interoceptive awareness, somatic symptoms, and autonomic and metabolic parameters will be associated with change in depressive symptom severity. To accomplish these aims, we will conduct an 8-week, double blinded, randomized, sham controlled, parallel group, pilot clinical trial study design. A total of 20 adult antidepressant-free MDD patients will be randomized to receive Active (n=10) or Sham (n=10) tsDCS protocols for 8 weeks in a 1:1 ratio. We will combine the use of a tsDCS device, psychometric instruments to diagnose MDD, and measures of depressive symptom severity, somatic symptoms, interoceptive awareness, autonomic function (blood pressure, heart rate), and potential metabolic markers as predictors of response.
- Conditions
- Major Depressive Disorder
- Being tested
- Active transcutaneous spinal direct current stimulation, Sham transcutaneous spinal direct current stimulation
- Keywords
- depression, transcutaneous spinal direct current stimulation, non-invasive, major depressive disorder
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active transcutaneous spinal direct current stimulationDevice
Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Sham transcutaneous spinal direct current stimulationDevice
Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Thoracic anodal transcutaneous spinal direct current stimulation 2.5 milliampere (mA) for 20 min/ three times per week for 8 weeks. Receives: Device: Active transcutaneous spinal direct current stimulation |
| Sham Treatment | Sham comparator | Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. Receives: Device: Sham transcutaneous spinal direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg Depression Rating Scale (MADRS) Score Change
Difference in change from baseline to week 8 (or last available observation) in Montgomery Asberg Depression Rating Scale summed total scores scores between active and sham transcutaneous spinal direct current stimulation (tsDCS) groups. Scores range from 0 to 60, with higher scores indicating worse depressive symptom severity.
Measured: 8 weeks (or last available observation).
Secondary outcomes (16)
Number of Participants With Skin Redness
Number of participants with skin redness in the active and sham tsDCS groups.
Measured: 8 weeks
Clinical Global Impression-Improvement (CGI-I)
Clinical Global Impression-Improvement (CGI-I) scale score at week 8 (or last available information) difference between Active and Sham tsDCS groups. Range is from 1 to 7 with lower scores indicating better outcome.
Measured: 8 weeks
Montgomery Asberg Depression Rating Scale (MADRS) Sub-component Score (Item 2) Change
MADRS Item 2 score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. MADRS Item 2 (Reported sadness) scores range from 0 to 6 and a higher score indicates a worse severity.
Measured: 8 weeks
Patient Health Questionnaire-9 (PHQ-9) Score Change
PHQ-9 score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Scores range from 0 to 27, with higher scores indicating worse severity.
Measured: 8 weeks
Multidimensional Assessment of Interoceptive Awareness (MAIA) Score Change-Noticing Subscale
MAIA Noticing subscale score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Noticing Subscale scores range 0 to 5 and higher scores indicate better outcomes.
Measured: 8 weeks
Binge Eating Scale (BES) Score Change
BES score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Scores range from 0 to 46, with higher scores indicating a worse outcome.
Measured: 8 weeks
Four-Dimensional Symptom Questionnaire (4-DSQ)- Somatization Dimension Score Change
4-DSQ Somatization dimension score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Somatization scale scores range from 0 to 32, with higher scores indicating a worse outcome.
Measured: 8 weeks
Systolic Blood Pressure Score Change
Systolic Blood Pressure score change in mmHg from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Normal range is considered below 140 mmHg. A greater decrease from baseline to week 8 in mmHg is considered favorable.
Measured: 8 weeks
Heart Rate Score Change
Heart Rate score change in beats per minute (BPM) from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Normal BPM is considered between 60 to 100. A decrease in value is considered favorable.
Measured: 8 weeks
Body Mass Index Change
Body mass index (BMI) change in kg/mts2 from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Normal range is 18 to 25 kg/mt2. A decrease in value is considered favorable.
Measured: 8 weeks
Adiponectin Level Change
Adiponectin level change (in ug/mL) from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. No normative levels available. Decreased levels are considered favorable in the context of the study.
Measured: 8 weeks
Leptin Level Change
Leptin level (in ng/ml) change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Usual normal range 4.7 - 23.7 ng/ML. Decreased levels are considered favorable.
Measured: 8 weeks
Cortisol Level Change
Cortisol level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Typical afternoon levels may range 5-10 nmol/L. Decreased levels are considered favorable outcomes.
Measured: 8 weeks
Insulin Level Change
Insulin level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Fasting range typically 16-166 Milli-international Units Per Liter (mIU/L). Decreased levels are considered a favorable outcome.
Measured: 8 weeks
Fibroblast Growth Factor-21 (FGF-21) Level Change
Fibroblast growth factor-21 (FGF-21) level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Levels in ng/ml. No normative range established. Decreased levels are considered favorable in the context of the study.
Measured: 8 weeks
Fatty Acid (LCn-3) Level Change
Fatty Acid (LCn-3) level percentage change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups. Results reported on Erythrocyte eicosapentaenoic acid + docosahexaenoic acid (EPA+DHA) percentage change. Increase in EPA+DHA would indicate a better outcome.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start29 Aug 2018
- Primary completion13 Sep 2022
- Study completion13 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 8-week, double blinded, randomized, sham controlled, parallel group, pilot clinical trial study design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Lindner Center of HOPE, Brain & Behavior Research Foundation
- Responsible party
- Principal investigator, Francisco Romo-Nava, University of Cincinnati
- Investigators
- Francisco Romo-Nava, MD,PhD, Principal investigator, University of Cincinnati/ Lindner Center of HOPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433339
- Sponsor's protocol ID
- SPIDEP 2017-7424
- Acronym
- SPIDEP
- Status last verified
- Dec 2024
- First submitted
- 8 Feb 2018
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: A plan for individual participant data is not included in the current protocol. Following Federal, State and Institutional regulations, data could be shared with other researchers after the study ends.
Publications
Romo-Nava F, Awosika OO, Basu I, Blom TJ, Welge J, Datta A, Guillen A, Guerdjikova AI, Fleck DE, Georgiev G, Mori N, Patino LR, DelBello MP, McNamara RK, Buijs RM, Frye MA, McElroy SL. Effect of non-invasive spinal cord stimulation in unmedicated adults with major depressive disorder: a pilot randomized controlled trial and induced current flow pattern. Mol Psychiatry. 2024 Mar;29(3):580-589. doi: 10.1038/s41380-023-02349-9. Epub 2023 Dec 20.
PubMed 38123726
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation for the Treatment of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT03433339
- Acronym / sponsor ID
- SPIDEP / SPIDEP 2017-7424
- Conditions
- Major Depressive Disorder
- Keywords
- depression, transcutaneous spinal direct current stimulation, non-invasive, major depressive disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Lindner Center of HOPE, Brain & Behavior Research Foundation
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Posted 23 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial will evaluate the efficacy and safety of transcutaneous direct current stimulation (tsDCS) in major depressive disorder.
Detailed description
This study aims to 1) determine the efficacy and safety of tsDCS in adult patients with major depressive disorder (MDD) and 2) investigate interoceptive awareness, somatic symptoms, autonomic and metabolic regulation as potential mediators of antidepressant response to tsDCS. We predict that 1) Active tsDCS treatment will result in a greater decrease in depressive symptom severity compared to Sham tsDCS in adult patients with MDD, 2) active tsDCS will be safe and well tolerated in adult patients with MDD and 3) change in interoceptive awareness, somatic symptoms, and autonomic and metabolic parameters will be associated with change in depressive symptom severity. To accomplish these aims, we will conduct an 8-week, double blinded, randomized, sham controlled, parallel group, pilot clinical trial study design. A total of 20 adult antidepressant-free MDD patients will be randomized to receive Active (n=10) or Sham (n=10) tsDCS protocols for 8 weeks in a 1:1 ratio. We will combine the use of a tsDCS device, psychometric instruments to diagnose MDD, and measures of depressive symptom severity, somatic symptoms, interoceptive awareness, autonomic function (blood pressure, heart rate), and potential metabolic markers as predictors of response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 8-week, double blinded, randomized, sham controlled, parallel group, pilot clinical trial study design.
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Device: Active transcutaneous spinal direct current stimulationThoracic anodal transcutaneous spinal direct current stimulation 2.5 milliampere (mA) for 20 min/ three times per week for 8 weeks. |
| Sham Treatment | Sham comparator | Device: Sham transcutaneous spinal direct current stimulationThoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- age 18-55 yrs., inclusive
- female or male
- Body mass index (BMI) 18.5 to 35 kg/mts2, inclusive
- current MDD episode diagnoses confirmed by Mini International Neuropsychiatric Interview (MINI) 5.0 with a duration of ≥1 month and ≤24 months
- moderate MDD symptoms according to Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20 to ≤35
Key exclusion criteria (12 listed)
- Current or lifetime MDD episode non-responsive to two or more antidepressant treatments at adequate doses and time (including ECT)
- Current or lifetime bipolar disorder or schizophrenia diagnosis
- current (past month): PTSD, psychotic or substance use disorder (nicotine and caffeine allowed)
- significant risk of suicide according to Columbia Suicide Severity Rating Scale (CSSRS) or clinical judgment, or suicidal behavior in the past year
- current chronic severe pain conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active transcutaneous spinal direct current stimulationActive anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder. | Device | Active Treatment |
| Sham transcutaneous spinal direct current stimulationSham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder. | Device | Sham Treatment |
Primary outcome
Montgomery Asberg Depression Rating Scale (MADRS) Score Change
Time frame: 8 weeks (or last available observation).
Difference in change from baseline to week 8 (or last available observation) in Montgomery Asberg Depression Rating Scale summed total scores scores between active and sham transcutaneous spinal direct current stimulation (tsDCS) groups. Scores range from 0 to 60, with higher scores indicating worse depressive symptom severity.
16 secondary outcomes
Number of Participants With Skin Redness
Time frame: 8 weeks
Clinical Global Impression-Improvement (CGI-I)
Time frame: 8 weeks
Montgomery Asberg Depression Rating Scale (MADRS) Sub-component Score (Item 2) Change
Time frame: 8 weeks
Patient Health Questionnaire-9 (PHQ-9) Score Change
Time frame: 8 weeks
Multidimensional Assessment of Interoceptive Awareness (MAIA) Score Change-Noticing Subscale
Time frame: 8 weeks
Binge Eating Scale (BES) Score Change
Time frame: 8 weeks
Four-Dimensional Symptom Questionnaire (4-DSQ)- Somatization Dimension Score Change
Time frame: 8 weeks
Systolic Blood Pressure Score Change
Time frame: 8 weeks
Heart Rate Score Change
Time frame: 8 weeks
Body Mass Index Change
Time frame: 8 weeks
Adiponectin Level Change
Time frame: 8 weeks
Leptin Level Change
Time frame: 8 weeks
Cortisol Level Change
Time frame: 8 weeks
Insulin Level Change
Time frame: 8 weeks
Fibroblast Growth Factor-21 (FGF-21) Level Change
Time frame: 8 weeks
Fatty Acid (LCn-3) Level Change
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38123726Romo-Nava F, Awosika OO, Basu I, Blom TJ, Welge J, Datta A, Guillen A, Guerdjikova AI, Fleck DE, Georgiev G, Mori N, Patino LR, DelBello MP, McNamara RK, Buijs RM, Frye MA, McElroy SL. Effect of non-invasive spinal cord stimulation in unmedicated adults with major depressive disorder: a pilot randomized controlled trial and induced current flow pattern. Mol Psychiatry. 2024 Mar;29(3):580-589. doi: 10.1038/s41380-023-02349-9. Epub 2023 Dec 20.
- Individual participant dataSharing planned: Undecided. A plan for individual participant data is not included in the current protocol. Following Federal, State and Institutional regulations, data could be shared with other researchers after the study ends.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Romo-Nava, MD,PhD principal investigator
University of Cincinnati/ Lindner Center of HOPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Active transcutaneous spinal direct current stimulation in people with Major Depressive Disorder, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery Asberg Depression Rating Scale (MADRS) Score Change (time frame: 8 weeks (or last available observation).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03433339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.