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.
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
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.
Inclusion Criteria:
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:
Exclusion Criteria:
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.
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):
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:
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.