Major Depressive DisorderNCT03222752
Efficacy of Cranial Electrotherapy Stimulation (CES) for the Treatment of Major Depressive Disorder
A study testing Cranial Electrotherapy Stimulation in people with Major Depressive Disorder, run by Electromedical Products International, Inc. at 1 site in United States.
Trial summary
Efficacy of Cranial Electrotherapy Stimulation (CES) for the treatment of Major Depressive Disorder Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Cranial Electrotherapy Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2017to 25 Apr 2023
- 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 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must be able to provide informed consent and sign the informed consent form prior to the conduct of any study specific procedures. To be eligible to participate in the study, patients must meet the following criteria:
- Subject is a male or female outpatient age 22 to 65 years, inclusive.
- Subject meets DSM-5 criteria for MDD as determined by MINI screening interview.
- The subject has a score of > 4 on CGI-S on visit 1 and 2.
- Sexually active female patients of childbearing potential must be practicing at least one or more the following methods of contraception during the study: intrauterine device (IUD), barrier method in combination with a spermicide, oral/hormonal contraception or abstinence. Female patients of childbearing potential must have a negative pregnancy test prior to receiving study treatment.
- Subject is in good medical health or with chronic medical conditions which are currently stable.
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- No current abuse of alcohol or other substance.
- Capable of doing active or sham CES treatments and completing all study requirements independently.
- The subject has a score of ≥ 17 on the HAM-D. If a subject is being treated with Serotonin Selective Reuptake Inhibitor (SSRIs) medications which include: Fluoxetine (Prozac), Paroxetine (Paxil), Sertraline (Zoloft), Luvox (Fluvoxamine), Citalopram (Celexa) and Escitalopram (Lexapro), as well as serotonin and norepinephrine reuptake inhibitors (SNRI) such as Venlafaxine (Effexor IR and XR), Desvenlafaxine (Pristiq) and Duloxetine (Cymbalta) they may remain on one of the SSRI or SNRI medications provided that he or she has been on a stable dose for at least 4 weeks prior to entering this study; this dose is to remain stable throughout the remainder of this study (any need to change the dose during the study will be evaluated and will result in termination).
Who cannot join
- Patients will be not be considered for inclusion into the study if they meet any of the conditions below:
- Subject meets DSM-5 criteria for another axis 1 disorder (other than MDD) as the primary diagnosis (i.e., schizophrenia, mood disorder, psychosis, anorexia nervosa) as determined by the MINI. Conduct and antisocial personality disorders will not be allowed to participate. Patients with comorbid diagnoses of learning disorders, attention deficit disorder (with or without hyperactivity), communication disorders, separation anxiety disorder, dysthymic disorder or anxiety disorders will be allowed to participate in the study as long as these conditions are not the primary focus of any treatment and they comply with concomitant medication limitations listed in the appendix. Those with substance use disorders will not be allowed to participate.
- Subject is clinically judged by the investigator to be at risk for suicide or is acutely suicidal as objectively measured by the C-SSRS.
- Subject has attempted suicide one or more times within the past 12 months
- Subject has a Hamilton Depression Rating Scale17 (HAM-D17) score above 38 which suggests a moderate to severe clinical level of depressive symptoms
- Subject has a psychiatric condition that would require inpatient, or partial psychiatric hospitalization.
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- There is an imminent risk of injuring self or others or causing damage to property as judged by the investigator.
- Subject has a significant history of medical disease (i.e., cardiovascular, hepatic (e.g., cirrhosis, hepatitis B or C) renal, gynecological, musculoskeletal, neurological, gastrointestinal, metabolic, hematological, endocrine, cancer with a metastatic potential, progressive neurological disorders or seizure disorder) which could impair reliable participation in the trial or necessitate the use of medication not allowed by this protocol unless all of the following are true (consultation with study physician is encouraged before patient enrollment):
- The condition has been stable for over one year (3 years for malignancy other than excised basal cell carcinoma, for which one year stability is required).
- The condition has been judged by the Investigator not to interfere with the patient's participation in the study.
- The condition is fully documented in the patient's study records.
- Hypo- or hyperthyroidism, unless stabilized on appropriate pharmacotherapy with no change in dosage for at least three months before visit 1 (Screening).
- Subject is pregnant, planning to become pregnant, or nursing. If a subject becomes pregnant, she will be discontinued immediately and followed appropriately.
- For females who are sexually active:
- Not practicing a reliable method of contraception that will continue for the duration of the study and within 30 days following the end of study participation.
- Reliable contraception is defined as:
- surgical sterilization
- oral contraceptives (consisting of an estrogen-progestin combination or progestin alone
- transdermally derived contraceptives (e.g., Ortho - Evra), depot injections (e.g., Depo-Provera)
- vagina contraceptive ring (e.g., Nucaring), contraceptive implants (e.g., Implanon, Norplant 2/Jadelle)
- an intrauterine device
- diaphragm plus condom (the only acceptable double barrier method)
- other forms of contraceptives (pharmacological and/or non-pharmacological) are not accepted
- Subject has had concomitant therapy with another investigational drug, or participation in an investigational drug study within one month prior to entering this study.
- Subject who has initiated or terminated psychotherapy or behavior therapy within one month before visit 1 (screening), or who plans to initiate or change such therapy during the course of the study.
- Subject has history of poor compliance or in the Investigator's opinion any subject whose treatment as an outpatient would be clinically contraindicated.
- Subject has had previous trial of cranial electrotherapy stimulation (CES).
- Subject requiring prohibited concomitant medication or herbal supplements that could not be discontinued or switched to an allowable alternative medication and stabilized for at least two weeks preceding (visit 2).
- Subject taking any psychoactive drug or herbal remedy within 5 half-lives before baseline (visit 2), (St. John's wort, ginkgo biloba, kava kava, valerian root, DHEA, tyrosine, tryptophan and 5-HTP, antidepressants, anxiolytics, monoamine oxidase inhibitors, antipsychotics, or anticonvulsants/mood stabilizers, carbamazepine, or others). Patients who have ever been treated with the depot antipsychotic must also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 6 Week, Randomized, Double-blind, Placebo Controlled Trial of the Efficacy and Tolerability of Cranial Electrotherapy Stimulation for the Treatment of Major Depressive Disorder, With a 6 Week Open Label Extension Phase.
Efficacy of Cranial Electrotherapy Stimulation (CES) for the treatment of Major Depressive Disorder
Read the detailed description
A 6 week, randomized, double-blind, placebo controlled trial of the efficacy and tolerability of Cranial Electrotherapy Stimulation for the treatment of Major Depressive Disorder, with a 6 week open label extension phase.
- Conditions
- Major Depressive Disorder
- Being tested
- Cranial Electrotherapy Stimulation, Sham Cranial Electrotherapy Stimulation
- Keywords
- Alpha-Stim, Cranial Electrotherapy Stimulation, CES
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial Electrotherapy StimulationDevice
Also called Alpha-Stim
Alpha-Stim® AID microcurrent and cranial electrotherapy stimulator will be used. Daily one hour cranial electrotherapy stimulation (CES) treatment using ear clip electrodes with current set at fixed level of 100 uA (a subsensory current level), 0.5 Hertz will be used for active CES treatment group for 6 weeks. For the sham group the Alpha-Stim® AID ear clips will not emit electricity.
Sham Cranial Electrotherapy StimulationDevice
Also called Sham Alpha-Stim
The sham treatment will be using a sham Alpha-Stim AID which will look and sound exactly like the active treatment but will deliver no current.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | Group receives active treatment for 6 weeks. The intervention used will be cranial electrotherapy stimulation from and Alpha-Stim AID. Receives: Device: Cranial Electrotherapy Stimulation |
| Sham Treatment Group | Sham comparator | Groups receives treatment using sham cranial electrotherapy stimulation devices for 6 weeks. No actual treatment will be received. This group will not receive any treatment interventions. The same outcome measures will be used as the treatment group. Receives: Device: Sham Cranial Electrotherapy Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale
The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), abbreviated HAM-D, is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
Measured: 6 weeks
Secondary outcomes (2)
Clinical Global Impression - Severity of Illness
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
Measured: 6 weeks
Clinical Global Impression - Global Improvement
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start5 Jun 2017
- Primary completion25 Apr 2023
- Study completion25 Apr 2023
Why it stopped: Participant recruitment insufficient to complete study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single site, 6 week, randomized, double-blind, placebo controlled evaluation of efficacy and tolerability of cranial electrotherapy stimulation (CES) for the treatment of adults from 18-65 years of age with treatment resistant Major Depressive Disorder (MDD) with a 6 week open label extension phase.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Electromedical Products International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Barclay, PhD, Principal investigator, Liberty University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222752
- Sponsor's protocol ID
- MDD1
- Status last verified
- Apr 2023
- First submitted
- 19 Jun 2017
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: PI will maintain all patient data during the trial. Data will be de identified and encrypted before sending to the designated statistician.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6 Week, Randomized, Double-blind, Placebo Controlled Trial of the Efficacy and Tolerability of Cranial Electrotherapy Stimulation for the Treatment of Major Depressive Disorder, With a 6 Week Open Label Extension Phase.
- ClinicalTrials.gov ID
- NCT03222752
- Acronym / sponsor ID
- MDD1
- Conditions
- Major Depressive Disorder
- Keywords
- Alpha-Stim, Cranial Electrotherapy Stimulation, CES
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participant recruitment insufficient to complete study
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Electromedical Products International, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 19 Jul 2017 (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.
Efficacy of Cranial Electrotherapy Stimulation (CES) for the treatment of Major Depressive Disorder
Detailed description
A 6 week, randomized, double-blind, placebo controlled trial of the efficacy and tolerability of Cranial Electrotherapy Stimulation for the treatment of Major Depressive Disorder, with a 6 week open label extension phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A single site, 6 week, randomized, double-blind, placebo controlled evaluation of efficacy and tolerability of cranial electrotherapy stimulation (CES) for the treatment of adults from 18-65 years of age with treatment resistant Major Depressive Disorder (MDD) with a 6 week open label extension phase.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Device: Cranial Electrotherapy StimulationGroup receives active treatment for 6 weeks. The intervention used will be cranial electrotherapy stimulation from and Alpha-Stim AID. |
| Sham Treatment Group | Sham comparator | Device: Sham Cranial Electrotherapy StimulationGroups receives treatment using sham cranial electrotherapy stimulation devices for 6 weeks. No actual treatment will be received. This group will not receive any treatment interventions. The same outcome measures will be used as the treatment group. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must be able to provide informed consent and sign the informed consent form prior to the conduct of any study specific procedures. To be eligible to participate in the study, patients must meet the following criteria:
- Subject is a male or female outpatient age 22 to 65 years, inclusive.
- Subject meets DSM-5 criteria for MDD as determined by MINI screening interview.
- The subject has a score of > 4 on CGI-S on visit 1 and 2.
- Sexually active female patients of childbearing potential must be practicing at least one or more the following methods of contraception during the study: intrauterine device (IUD), barrier method in combination with a spermicide, oral/hormonal contraception or abstinence. Female patients of childbearing potential must have a negative pregnancy test prior to receiving study treatment.
Key exclusion criteria (29 listed)
- Patients will be not be considered for inclusion into the study if they meet any of the conditions below:
- Subject meets DSM-5 criteria for another axis 1 disorder (other than MDD) as the primary diagnosis (i.e., schizophrenia, mood disorder, psychosis, anorexia nervosa) as determined by the MINI. Conduct and antisocial personality disorders will not be allowed to participate. Patients with comorbid diagnoses of learning disorders, attention deficit disorder (with or without hyperactivity), communication disorders, separation anxiety disorder, dysthymic disorder or anxiety disorders will be allowed to participate in the study as long as these conditions are not the primary focus of any treatment and they comply with concomitant medication limitations listed in the appendix. Those with substance use disorders will not be allowed to participate.
- Subject is clinically judged by the investigator to be at risk for suicide or is acutely suicidal as objectively measured by the C-SSRS.
- Subject has attempted suicide one or more times within the past 12 months
- Subject has a Hamilton Depression Rating Scale17 (HAM-D17) score above 38 which suggests a moderate to severe clinical level of depressive symptoms
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 |
|---|---|---|
| Cranial Electrotherapy StimulationAlso: Alpha-StimAlpha-Stim® AID microcurrent and cranial electrotherapy stimulator will be used. Daily one hour cranial electrotherapy stimulation (CES) treatment using ear clip electrodes with current set at fixed level of 100 uA (a subsensory current level), 0.5 Hertz will be used for active CES treatment group for 6 weeks. For the sham group the Alpha-Stim® AID ear clips will not emit electricity. | Device | Treatment Group |
| Sham Cranial Electrotherapy StimulationAlso: Sham Alpha-StimThe sham treatment will be using a sham Alpha-Stim AID which will look and sound exactly like the active treatment but will deliver no current. | Device | Sham Treatment Group |
Primary outcome
Hamilton Depression Scale
Time frame: 6 weeks
The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), abbreviated HAM-D, is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
2 secondary outcomes
Clinical Global Impression - Severity of Illness
Time frame: 6 weeks
Clinical Global Impression - Global Improvement
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Participant recruitment insufficient to complete study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: No. PI will maintain all patient data during the trial. Data will be de identified and encrypted before sending to the designated statistician.
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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.
Timothy Barclay, PhD principal investigator
Liberty University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial Electrotherapy Stimulation in people with Major Depressive Disorder, run by Electromedical Products International, Inc. 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 29 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 27 Apr 2023. 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.
Are results available for this study?
The study was stopped early (reason given: Participant recruitment insufficient to complete study). 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 Scale (time frame: 6 weeks). 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 27 Apr 2023.