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Behavioural Intervention
Non-Invasive Nerve Stimulation for Depression (MDD Trial)
N/A
Recruiting
Led By Linda Carpenter, MD
Research Sponsored by Neurolief Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Up to 36 randomized subjects aged 18-21
Current MDD episode lasts up to three years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks from treatment initiation
Awards & highlights
MDD Trial Summary
This trial is testing a new self-administered, non-invasive treatment for Major Depressive Disorder. The treatment will be given for 8 weeks, and then the participants will be monitored for an additional 8 weeks to see if the treatment was effective.
Who is the study for?
This trial is for adults aged 18-70 with Major Depressive Disorder (MDD) who haven't had enough improvement from 1-4 antidepressant treatments. Participants must be able to use a smartphone and commit to the study requirements, including staying on their current antidepressant dose throughout the trial.Check my eligibility
What is being tested?
The MOOD Study tests Relivion®DP, a noninvasive neurostimulation device for MDD treatment. It's a double-blind study comparing active treatment with a sham (placebo) control over an initial 8-week period followed by an open label phase where all receive active treatment for another 8 weeks.See study design
What are the potential side effects?
Potential side effects are not detailed in the provided information but may include discomfort or skin irritation at electrode sites due to the nature of neurostimulation devices.
MDD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 21 years old.
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My current episode of depression has lasted up to 3 years.
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The person has a score of 20 or more on the Hamilton Depression Rating Scale.
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Had a less than 50% response or no response to the treatment; the dose and duration were defined and rated at a minimum confidence level of 3 on the ATRF.
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I've tried 1-4 antidepressants without enough improvement or couldn't tolerate at least 2.
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I am taking an antidepressant and can keep the dose the same for at least 28 days.
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I am between 18 and 70 years old.
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I am between 22 and 70 years old.
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I have been diagnosed with major depression.
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My current episode of depression has lasted up to 3 years.
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I am currently experiencing a major depressive episode.
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I've tried 1-4 antidepressants without enough improvement.
Select...
I can understand and agree to the study's requirements.
MDD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks from treatment initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks from treatment initiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change in depressive symptoms, measured by HDRS17 total score
Secondary outcome measures
Mean change in depressive symptoms, measured by MADRS total score
Proportion of responder subjects
Proportion of subjects achieving remission
Other outcome measures
Mean Change in Quick Inventory of Depressive Symptomatology self-rated score
Mean Change in depressive symptoms severity and improvement scores
Mean change in depressive symptoms, measured by HDRS21 total score
MDD Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1 - active stimulationExperimental Treatment1 Intervention
Group II: Group 2 - sham stimulationPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Neurolief Ltd.Lead Sponsor
7 Previous Clinical Trials
415 Total Patients Enrolled
2 Trials studying Depression
68 Patients Enrolled for Depression
Linda Carpenter, MDPrincipal InvestigatorButler Hospital, Brown Department of Psychiatry and Human, RI, USA Behavior,
5 Previous Clinical Trials
99 Total Patients Enrolled
3 Trials studying Depression
76 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My main diagnosis in the past month is OCD or PTSD.I am not currently undergoing any brain stimulation therapies.I am between 18 and 21 years old.I have not had TMS treatment in the last 6 months.You have a history or signs of bipolar depression or depression with psychosis, according to the doctor's judgment.I had a brain injury from a hit or accident less than 3 months ago.I did not improve after trying electroconvulsive therapy for depression.Within the past year, you have experienced symptoms or been diagnosed with conditions like psychosis, schizophrenia, or other mental disorders that affect your thinking and perception.I have skin issues where the electrodes will be placed.Had a less than 50% response or no response to the treatment; the dose and duration were defined and rated at a minimum confidence level of 3 on the ATRF.I have had nerve block injections in my head within the last month.You have already participated in a study involving the Relivion®DP or the Relivion® device.I do not have a neurological condition that could be confused with depression.I am currently experiencing a major depressive episode.My head size is either below 51cm or above 60cm.I have not had Botox in my head or neck in the last 90 days.You have been diagnosed with a problem with alcohol or drugs in the past six months.I've tried 1-4 antidepressants without enough improvement or couldn't tolerate at least 2.I can understand and agree to the study's requirements.I've tried 1-4 antidepressants without enough improvement.I am between 18 and 70 years old.I am between 22 and 70 years old.The person has a score of 20 or more on the Hamilton Depression Rating Scale.I am taking an antidepressant and can keep the dose the same for at least 28 days.My current episode of depression has lasted up to 3 years.My current episode of depression has lasted up to 3 years.I have been diagnosed with major depression.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 - active stimulation
- Group 2: Group 2 - sham stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT04279522 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Might I be a suitable candidate for enrollment in this investigation?
"This clinical trial is recruiting 160 individuals aged 18-70, suffering from Major Depressive Disorder. To qualify for the study, participants must have had an MDD episode lasting up to three years and scoring 20 or higher on the Hamilton Depression Rating Scale (HDRS21). They should also not have responded well to less than 50% improvement after one to four adequate trials of antidepressant medications; two inadequate medication trails due to poor tolerability; and been receiving psychotherapy for at least one month prior with a regular frequency regimen judged suitable by their investigator. Additionally, those being recruited should be taking at least one antidepressant daily dose that they are willing to"
Answered by AI
Is the age limit for participating in this trial beyond 25 years old?
"This clinical trial dictates that only persons aged between 18 and 70 may enrol. Alternatively, there are 107 distinct trials for minors and 596 studies specifically targeting those over 65 years of age."
Answered by AI
Are recruitment activities still underway for this research?
"Yes, according to data on clinicaltrials.gov, patient recruitment for this medical trial is ongoing. It was first posted on August 31st 2021 and the latest update came October 10th 2022. The study needs 160 participants from 12 distinct sites around the country."
Answered by AI
How many locations are providing access to this scientific trial?
"The Sheppard Pratt Health system in Baltimore, Maryland, Butler Hospital/Brown University in Providence, Rhode island, and Kadima Neuropsychiatry Institute in La Jolla California are some of the numerous enrolment sites for this trial. In addition to these locations there 12 other recruiting centres."
Answered by AI
What is the current capacity of this clinical trial to enroll participants?
"Neurolief Ltd. is responsible for the execution of this trial, which necessitates a total of 160 participants that meet its entry requirements. Those taking part will be based in several locales such as Sheppard Pratt Health System located in Baltimore and Butler Hospital/Brown University situated in Providence."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Texas
What site did they apply to?
Brain Health Consultants and TMS Center
UCLA Semel Institute for Neuroscience and Behaviour
K2 Medical Research Tampa
Other
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Treatment resistant major depressive disorder. I tried other meds and they don't work real well, I'm hoping a new med will.
PatientReceived 1 prior treatment
I've tried numerous antidepressants as well as adjunct medications over 25 years. I'm now disabled at 42 because my depression, anxiety and PTSD is overwhelming. I've lost all hope.
PatientReceived 2+ prior treatments
I have tried TMS which helped me but my insurance would not pay for my maintenance. ECT helped but I do not want to return yet. I have been on numerous medications. Certainly more than 3.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
I would like to know about compensation, whether it's in or out patient, and whether you can provide transportation?
PatientReceived no prior treatments
How responsive is this trial?
Average response time
- < 1 Day
Most responsive sites:
- K2 Medical Research Tampa: < 24 hours
Typically responds via
Phone Call
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