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New treatment option for Major Depressive Disorder
Official title Temporal Interference and Depression
ClinicalTrials.gov ID: NCT05295888
What this study is testing
- What it's testing
- Major Depressive Disorder (MDD) has a high prevalence, is the leading cause of disability, and currently available interventions are associated with side effects and high treatment resistance. There is an urgent need for the development of novel interventions for MDD with alternate mechanisms of action.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patients will be included if they:
- provide written informed consent before initiation of any study-related procedures
- are outpatients
- meet the DSM-5 criteria for major depressive disorder (MDD) with a current major depressive episode (MDE) without psychotic features as confirmed at...
- are male or female, 18 to 65 years of age (inclusive) at screening
You likely can't join if
- Patients will be excluded if they:
- have an acute alcohol or substance use disorder, withdrawal symptoms requiring detoxification, or went through detoxification treatment (inpatient or...
- have a concomitant major unstable medical illness, active hepatitis B virus (HBV), hepatitis C virus (HPC), human immunodeficiency virus (HIV)...
- have active suicidal intent, confirmed by a 'Yes' response to Question B3 AND either Question B10 or B11, obtained from the MINI Suicidality, Module...
- have a current clinical diagnosis of autism, dementia, or intellectual disability
- take medications prohibited by the protocol. Medications will be reviewed by the responsible MD
See the full eligibility criteria
Who can join
- Patients will be included if they:
- provide written informed consent before initiation of any study-related procedures
- are outpatients
- meet the DSM-5 criteria for major depressive disorder (MDD) with a current major depressive episode (MDE) without psychotic features as confirmed at Screening by the Mini International Neuropsychiatric Interview (MINI)
- are male or female, 18 to 65 years of age (inclusive) at screening
- have a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥ 20 (moderate to severe depression) at screening
- have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
- able to adhere to the treatment schedule
- pass the TI adult safety screening questionnaire
- are able to understand and comply with the requirements of the study, as judged by the investigator(s)
What rules you out
- Patients will be excluded if they:
- have an acute alcohol or substance use disorder, withdrawal symptoms requiring detoxification, or went through detoxification treatment (inpatient or outpatient) within 3 months before Screening, as obtained from MINI...
- have a concomitant major unstable medical illness, active hepatitis B virus (HBV), hepatitis C virus (HPC), human immunodeficiency virus (HIV), active COVID-19 infection, cardiac pacemaker or implanted medication pump...
- have active suicidal intent, confirmed by a 'Yes' response to Question B3 AND either Question B10 or B11, obtained from the MINI Suicidality, Module B (Suicidality), OR confirmed by the MADRS item #10 score ≥ 4, both...
- have a current clinical diagnosis of autism, dementia, or intellectual disability
- take medications prohibited by the protocol. Medications will be reviewed by the responsible MD
- are pregnant or lactating
- have any prior or current diagnosis of bipolar I or II disorder, MDD with psychotic features, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms as...
- have any prior or current diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), confirmed by MINI and assessed by a study investigator to be primary and causing...
- have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
- have received TI for any previous indication due to the potential compromise of subject blinding
- have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space-occupying brain lesion, any history of seizure except...
- have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
- if participating in psychotherapy, have NOT been in stable treatment for at least 3 months prior to entry into the study or anticipate change in the frequency of therapeutic sessions or therapeutic focus over the...
- have a clinically significant laboratory abnormality, in the opinion of one of the principal investigators or study physicians
- currently take medications that potentially limit the TI how well it works
- have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with an interview)
- have a clinical finding that is unstable or that, in the opinion of the investigator(s), would be negatively affected by the study medication or that would affect the study medication (e.g., diabetes mellitus...
- have uncorrected hypothyroidism or hyperthyroidism. people needing a thyroid hormone supplement to treat hypothyroidism will be excluded if they have NOT been on a stable dose of the medication for 30 days prior to...
- have any other condition that, in the opinion of the investigator(s), would adversely affect the subject's ability to complete the study or its measure
- wear a hairstyle or headdress at the time of the stimulation that prevents electrode contact with the scalp or would interfere with the stimulation (e.g., thick or curly hair)
- have any contraindications for receiving TI or undergoing MRI scans (e.g., hip circumference \>180 cm or metal in the body)
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.