Mild to Moderate DepressionTESAHBPilotNCT03471754
Pilot Study Using Transcranial Electrostimulation (TESA-HB) Therapy for the Treatment of Depressive Symptoms
A study testing TESA-HB Transcranial Electronic Stimulation Device in people with Mild to Moderate Depression, run by Annecto LLC at 1 site in United States.
Trial summary
This pilot study uses TESA-HB therapy for treatment of depressive symptoms associated with mild and moderate depression episodes. Primary objectives of this pilot study are to demonstrate the safety of TESA-HB Therapy, and to investigate the efficacy of TESA-HB Therapy for depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild to Moderate Depression
- What is being tested?
- TESA-HB Transcranial Electronic Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2017to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18-65 years old on enrollment
- Assessed by Evaluator with mild to moderate depressive episode, based on the MDI Rating Scale (20-24 mild; 25-29 moderate).
- Have average MDI pain rating score of > 20 or <29 during baseline
- Assessed by Evaluator to have mild to moderate depressive episode, based on the HAM-D21 Rating Scale (8-13 = mild; 14-17 moderate).
- Assessed by Evaluator to have mild to moderate depressive episode based on ICD-10 Diagnostic Guidelines 1,2
- Willing and able to visit 2 weeks ( 5 times per week) as a clinic outpatient to participate in this clinical investigation
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- Willing and able to return to the clinic for evaluation during the follow up period - 2 weeks, 1 month (4 wks), 2 months (8 wks), and 3 months (12wks) following the completion of TESA-HB Therapy
- Willing to be monitored, fill out daily medication logs, and appear for all physician visits for baseline, treatment and follow-up period
- English speaking and able to understand and approve the consent form, and understand and provide answers on the Depression and Anxiety assessment form and the Psychological General Well-Being Index (PGWB-S) questionnaires
Who cannot join
- High variability in baseline MDI scores (changes more than 30%)
- HAM-D21 Rating Scale of < 8 or > 17
- Assessed outside of mild to moderate depression episode range based on the ICD-10 Diagnostic Guidelines 1,2
- Recent history of taking Antidepressant or Antianxiety medication within 3 months prior to baseline
- Is pregnant, or may be pregnant, or plans to become pregnant during the study period
- Sensitivity to electrodes and/or their conductive gels or adhesives
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- Break in skin integrity at the areas of electrode placement
- Currently suspected use of narcotic
- Presence of any implanted electronic device, cardiac stimulator, or pacemaker
- History of brain injury, including seizures, epilepsy, stroke, tumor of central nervous system, or hydrocephalus
- Acute brain injuries, infections or tumor of central nervous system
- History of heart attacks within 1year congestive heart failure
- Blood pressure: > 140 systolic and/or > 90 diastolic
- History of schizophrenia
- Previous experience with Cranial Electrotherapy Stimulator (CES) devices
- Failure to complete 80% of daily medication logs or complete a questionnaire and two physician assessments during baseline period
- Failed to complete 75% of follow up visits or failed to complete more than 2 treatments will be excluded in the per-protocol (PP) analysis
- Acute psychiatric disorders (other than depression, insomnia and/or anxiety)
- Use of psychoactive drugs (other than antidepressants and/or anxiety)
- These subjects will continue to be followed in the study, but will be classified in the intent-to-treat (ITT) group
- HRHS employees, in an effort to protect their privacy, as the study will be conducted in a Holy Redeemer facility. Additionally, this exclusion was decided upon to minimize the possibility of coercion or undue influence in relationship with Holy Redeemer employees.
- Illiterate persons, as the study requires completion of assessments tools in the home setting where the subject may/may not have assistance with reading and understanding the tools, study documents and proceedures as required.
- Uninsured persons, to financially protect them in the rare instance that medical care would be required as a result of the study treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Holy Redeemer Health Care at Bensalem, 3300 Tillman Drive
Bensalem, Pennsylvania, 19020
About this study
Official title: Pilot Study Using Transcranial Electrostimulation (TESA-HB) Therapy for the Treatment of Depressive Symptoms Associated With Mild to Moderate Depressive Episodes
This pilot study uses TESA-HB therapy for treatment of depressive symptoms associated with mild and moderate depression episodes. Primary objectives of this pilot study are to demonstrate the safety of TESA-HB Therapy, and to investigate the efficacy of TESA-HB Therapy for depressive symptoms.
Read the detailed description
The primary indicator variable in this study is the Hamilton Depression Rating Scale (HAM-D21), and secondary efficacy outcomes will be measured using:
- Major Depression Inventory
- Montgomery - Asberg Depression Rating Scale (MADRS)
- Beck's Depression Inventory
- Beck's Anxiety Inventory
- Hamilton Anxiety Rating Scale (HAM-A)
- The Psychological General Well-Being Index (PGWB-S)
The safety endpoints include:
- Medication Usage Log
- Adverse Event Log
Study Population includes men and women who are:
- Diagnosed with a mild to moderate depressive episode
- Have no recent history of taking antidepressant or anti-anxiety medication within 3 months prior to baseline
- Conditions
- Mild to Moderate Depression
- Being tested
- TESA-HB Transcranial Electronic Stimulation Device
- Keywords
- Depression, transcranial electronic stimulation, pilot, open label, safety, efficacy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TESA-HB Transcranial Electronic Stimulation DeviceDevice
Duration of treatment: 50 Minute Therapy sessions administered one time each day, for two 5-day cycles
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm A | Experimental | TESA-HB Device, Mode 3 (15mA). Treatment arm involves two 5-day treatment cycles over a 2-week period, with 2 days off between each of the 5-day cycles. The treatment period will as for two full weeks. Receives: Device: TESA-HB Transcranial Electronic Stimulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HAM-D21)
The HAM-D21 will be analyzed as a single measure result
Measured: Statistically significant improvement from baseline to end of study period (4 months)
Medication Usage Log
Will be used in total, as a covariate in analysis of primary outcome
Measured: Statistically significant improvement from baseline to end of study period (4 months)
Secondary outcomes (7)
Montgomery-Asberg Depression Rating Scale (MADRS)
Will be analyzed in total score
Measured: Statistically significant improvement from baseline to end of study period (4 months)
Major Depression Inventory (MDI)
Will be analyzed in total score
Measured: Statistically significant improvement from baseline to end of study period (4 months)
The Psychological General Well-Being Index (PGWB-S)
Will be analyzed in total score
Measured: Statistically significant improvement from baseline to end of study period (4 months)
Beck's Depression Inventory (BDI)
Will be analyzed in total score
Measured: Statistically significant improvement from baseline to end of study period (4 months)
Beck's Anxiety Inventory (BAI)
Will be analyzed in total score
Measured: Statistically significant improvement from baseline to end of study period (4 months)
Hamilton Anxiety Rating Scale (HAM-A)
Will be analyzed in total score
Measured: Statistically significant improvement from baseline to end of study period (4 months)
Medication Usage Log (MUL)
Will be analyzed in total score, with no covariate
Measured: Statistically significant improvement from baseline to end of study period (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start26 Sep 2017
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Why it stopped: Administrative reasons, and did not meet sample size requirements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate DepressionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot, Open Label, single center trial
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Annecto LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Holy Redeemer Hospital
- Responsible party
- Sponsor
- Investigators
- Beth DuPree, MD, MD, Principal investigator, Holy Redeemer HospitalYakov Katsnelson, MD, Study director, Annecto LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471754
- Sponsor's protocol ID
- TESAHB64-17
- Acronym
- TESAHBPilot
- Status last verified
- Feb 2019
- First submitted
- 14 Mar 2018
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Using Transcranial Electrostimulation (TESA-HB) Therapy for the Treatment of Depressive Symptoms Associated With Mild to Moderate Depressive Episodes
- ClinicalTrials.gov ID
- NCT03471754
- Acronym / sponsor ID
- TESAHBPilot / TESAHB64-17
- Conditions
- Mild to Moderate Depression
- Keywords
- Depression, transcranial electronic stimulation, pilot, open label, safety, efficacy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative reasons, and did not meet sample size requirements
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Annecto LLCUniversity, hospital or other
- Collaborators
- Holy Redeemer Hospital
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study uses TESA-HB therapy for treatment of depressive symptoms associated with mild and moderate depression episodes. Primary objectives of this pilot study are to demonstrate the safety of TESA-HB Therapy, and to investigate the efficacy of TESA-HB Therapy for depressive symptoms.
Detailed description
The primary indicator variable in this study is the Hamilton Depression Rating Scale (HAM-D21), and secondary efficacy outcomes will be measured using:
- Major Depression Inventory
- Montgomery - Asberg Depression Rating Scale (MADRS)
- Beck's Depression Inventory
- Beck's Anxiety Inventory
- Hamilton Anxiety Rating Scale (HAM-A)
- The Psychological General Well-Being Index (PGWB-S)
The safety endpoints include:
- Medication Usage Log
- Adverse Event Log
Study Population includes men and women who are:
- Diagnosed with a mild to moderate depressive episode
- Have no recent history of taking antidepressant or anti-anxiety medication within 3 months prior to baseline
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot, Open Label, single center trial
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm A | Experimental | Device: TESA-HB Transcranial Electronic Stimulation DeviceTESA-HB Device, Mode 3 (15mA). Treatment arm involves two 5-day treatment cycles over a 2-week period, with 2 days off between each of the 5-day cycles. The treatment period will as for two full weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Between the ages of 18-65 years old on enrollment
- Assessed by Evaluator with mild to moderate depressive episode, based on the MDI Rating Scale (20-24 mild; 25-29 moderate).
- Have average MDI pain rating score of > 20 or <29 during baseline
- Assessed by Evaluator to have mild to moderate depressive episode, based on the HAM-D21 Rating Scale (8-13 = mild; 14-17 moderate).
- Assessed by Evaluator to have mild to moderate depressive episode based on ICD-10 Diagnostic Guidelines 1,2
Key exclusion criteria (23 listed)
- High variability in baseline MDI scores (changes more than 30%)
- HAM-D21 Rating Scale of < 8 or > 17
- Assessed outside of mild to moderate depression episode range based on the ICD-10 Diagnostic Guidelines 1,2
- Recent history of taking Antidepressant or Antianxiety medication within 3 months prior to baseline
- Is pregnant, or may be pregnant, or plans to become pregnant during the study period
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 |
|---|---|---|
| TESA-HB Transcranial Electronic Stimulation DeviceDuration of treatment: 50 Minute Therapy sessions administered one time each day, for two 5-day cycles | Device | Treatment Arm A |
Primary outcome
Hamilton Depression Rating Scale (HAM-D21)
Time frame: Statistically significant improvement from baseline to end of study period (4 months)
The HAM-D21 will be analyzed as a single measure result
Medication Usage Log
Time frame: Statistically significant improvement from baseline to end of study period (4 months)
Will be used in total, as a covariate in analysis of primary outcome
7 secondary outcomes
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Statistically significant improvement from baseline to end of study period (4 months)
Major Depression Inventory (MDI)
Time frame: Statistically significant improvement from baseline to end of study period (4 months)
The Psychological General Well-Being Index (PGWB-S)
Time frame: Statistically significant improvement from baseline to end of study period (4 months)
Beck's Depression Inventory (BDI)
Time frame: Statistically significant improvement from baseline to end of study period (4 months)
Beck's Anxiety Inventory (BAI)
Time frame: Statistically significant improvement from baseline to end of study period (4 months)
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Statistically significant improvement from baseline to end of study period (4 months)
Medication Usage Log (MUL)
Time frame: Statistically significant improvement from baseline to end of study period (4 months)
Results and safety
The study was stopped early (reason given: Administrative reasons, and did not meet sample size requirements). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Beth DuPree, MD, MD principal investigator
Holy Redeemer Hospital
Yakov Katsnelson, MD study director
Annecto LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TESA-HB Transcranial Electronic Stimulation Device in people with Mild to Moderate Depression, run by Annecto LLC 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 9 inclusion and 23 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: stopped early, as of the sponsor's last update on 5 Feb 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Administrative reasons, and did not meet sample size requirements). Results are not available in the source record.
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?
Hamilton Depression Rating Scale (HAM-D21) (time frame: Statistically significant improvement from baseline to end of study period (4 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2019.