Spinal Cord Stimulation for the Treatment of Major Depressive Disorder

NCT03433339 | Completed Phase 1 Results DMC FDA Device

• 1 other identifier: SPIDEP 2017-7424
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial will evaluate the efficacy and safety of transcutaneous direct current stimulation (tsDCS) in major depressive disorder.

Conditions

Major Depressive Disorder

Keywords

depression; transcutaneous spinal direct current stimulation; non-invasive; major depressive disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks (or last available observation).

Secondary Outcomes (16)

• Number of Participants With Skin Redness

  8 weeks

• Clinical Global Impression-Improvement (CGI-I)

  8 weeks

• Montgomery Asberg Depression Rating Scale (MADRS) Sub-component Score (Item 2) Change

  8 weeks

• Patient Health Questionnaire-9 (PHQ-9) Score Change

  8 weeks

• Multidimensional Assessment of Interoceptive Awareness (MAIA) Score Change-Noticing Subscale

  8 weeks

Study Arms (2)

Active Treatment

EXPERIMENTAL

Thoracic anodal transcutaneous spinal direct current stimulation 2.5 milliampere (mA) for 20 min/ three times per week for 8 weeks.

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.

Device: Sham transcutaneous spinal direct current stimulation

Interventions

Active transcutaneous spinal direct current stimulation DEVICE

Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.

Active Treatment

Sham transcutaneous spinal direct current stimulation DEVICE

Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.

Sham Treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• University of Cincinnati: lead
• Lindner Center of HOPE: collaborator
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

Lindner Center of HOPE/University of Cincinnati

Mason, Ohio, 45040, United States

Location

Related Publications (1)

• 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.

  PMID: 38123726 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

This is a proof of concept pilot feasibility clinical trial with a small sample size.

Results Point of Contact

• Title: Dr. Francisco Romo-Nava
• Organization: Lindner Center of HOPE/ University of Cincinnati Department of Psychiatry and Behavioral Neurosciences

romofo@ucmail.uc.edu

513-536-0725

Study Officials

• Francisco Romo-Nava, MD,PhD

  University of Cincinnati/ Lindner Center of HOPE

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An independent operator (trained personnel from the research team) will prepare the tsDCS device parameters for each session, but will not participate in the rest of the assessments. Patients and raters will remain blinded to spinal stimulation protocol assigned to each participant throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 8-week, double blinded, randomized, sham controlled, parallel group, pilot clinical trial study design.

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 14, 2018
• Study Start: August 29, 2018
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: December 27, 2024
• Results First Posted: April 23, 2024

Record last verified: 2024-12

Locations

US (1)