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New treatment option for Depressive Disorder, Major
Official title Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia
ClinicalTrials.gov ID: NCT06982820
What this study is testing
- What it's testing
- The purpose of this research is to learn more about a new treatment for individuals with Major Depressive Disorder (MDD) with heightened symptoms of anhedonia (i.e. loss of pleasure or interest in activities).
- Time commitment: about 10 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 75
You may be able to join if
- Primary Diagnosis of MDD with Anhedonia, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text...
- Fluency in written and spoken English.
- Able intellectually to understand the instructions
- Ability to give signed, informed consent either written or electronic (via REDCap eConsent).
- Normal or corrected-to-normal vision and hearing.
You likely can't join if
- Contraindications to MRI (e.g., metal in the body, claustrophobia).
- Any suicidal behavior in the past 1 year (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) assessed using...
- Diagnosis for current moderate or severe substance or alcohol use disorder (SUD/AUD) within the past month (as defined in DSM-5-substance use...
- Any unstable medical condition, as per the clinical judgement of the investigator.
- Any change in, or initiation of, fluoxetine within the past 8 weeks or of other SSRIs/SNRIs antidepressants, bupropion, stimulants, or other...
- Recent initiation (within the past 2 months) of psychotherapy; continuation of established maintenance supportive therapy will be permitted.
See the full eligibility criteria
- Primary Diagnosis of MDD with Anhedonia, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM5TR) - HDRS-17 score of ≥20, SHAPS-C score of ≥25.
- Fluency in written and spoken English.
- Able intellectually to understand the instructions
- Ability to give signed, informed consent either written or electronic (via REDCap eConsent).
- Normal or corrected-to-normal vision and hearing.
- Ability to adhere to the study schedule.
- Completed at least one antidepressant treatment course at an adequate dose and duration in the current episode per the ATRQ.
- Contraindications to MRI (e.g., metal in the body, claustrophobia).
- Any suicidal behavior in the past 1 year (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) assessed using Columbia -Suicide Severity Rating Scale (C-SSRS) prior to screening...
- Diagnosis for current moderate or severe substance or alcohol use disorder (SUD/AUD) within the past month (as defined in DSM-5-substance use disorder).
- Any unstable medical condition, as per the clinical judgement of the investigator.
- Any change in, or initiation of, fluoxetine within the past 8 weeks or of other SSRIs/SNRIs antidepressants, bupropion, stimulants, or other psychiatric medications within the past 4 weeks.
- Recent initiation (within the past 2 months) of psychotherapy; continuation of established maintenance supportive therapy will be permitted.
- Enrollment in another therapeutic clinical study at screening or within 2 months prior to screening or intended enrollment within the duration of this study.
The study team makes the final eligibility decision.
Where it's taking place
- Providence, Rhode Island, United States
- Houston, Texas, United States
- Ramat Gan, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 study runs about 10 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Providence, Rhode Island, United States; Houston, Texas, United States; Ramat Gan, Israel. 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.