Efficacy of Cranial Electrotherapy Stimulation (CES) for the Treatment of Major Depressive Disorder

NCT03222752 | Terminated FDA Device

• 1 other identifier: MDD1
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy of Cranial Electrotherapy Stimulation (CES) for the treatment of Major Depressive Disorder

Conditions

Major Depressive Disorder

Keywords

Alpha-Stim; Cranial Electrotherapy Stimulation; CES

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (2)

• Clinical Global Impression - Severity of Illness

  6 weeks

• Clinical Global Impression - Global Improvement

  6 weeks

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

Group receives active treatment for 6 weeks. The intervention used will be cranial electrotherapy stimulation from and Alpha-Stim AID.

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.

Device: Sham Cranial Electrotherapy Stimulation

Interventions

Cranial Electrotherapy Stimulation DEVICE

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.

Also known as: Alpha-Stim

Treatment Group

Sham Cranial Electrotherapy Stimulation DEVICE

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.

Also known as: Sham Alpha-Stim

Sham Treatment Group

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• Electromedical Products International, Inc.: lead

Study Sites (1)

Advanced Psychotherapeutics

Forest, Virginia, 24551, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Timothy Barclay, PhD

  Liberty University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Treatment device will deliver subsensory treatment while the sham device will deliver no treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: July 19, 2017
• Study Start: June 5, 2017
• Primary Completion: April 25, 2023
• Study Completion: April 25, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)