Is NCT06976697 recruiting in Boston, MA?

Yes, NCT06976697 is currently recruiting participants at its Boston, MA location. This major depressive disorder (mdd) clinical trial is actively enrolling qualified participants.

How do I join the major depressive disorder (mdd) clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Major Depressive Disorder (MDD) Clinical Trial in Boston, MA

About This Major Depressive Disorder (MDD) Study in Boston

The REACH-tDCS study will evaluate the safety and efficacy of a noninvasive, at-home self-administered Sooma tDCS brain stimulation treatment for Major Depressive Disorder. The study uses randomized, blinded, placebo controlled design. The participants are assessed with video interviews and self-reports during the study, which lasts for 10 weeks followed by an optional continuation period.

Sponsor: Sooma Medical Inc

Who Can Participate

Inclusion Criteria

22 - 70 years of age

Diagnosis of Unipolar MDD (DSM-V)

PHQ-9 score of ≥12 AND MADRS score of ≥ 20 at baseline

Antidepressant medication ongoing

If in psychotherapy, have maintained stable psychotherapy

Have access to a smartphone or other device running Android 7.0+ or iPhone Operating System (iOS) 13+

Be under the care of a psychiatrist or a primary care physician

Allow communication between the investigators/study staff and any healthcare provider who currently provides and/or has provided service to the patient/subject within at least two years

Provide the name and contact of at least two adult persons who reside within a 60-minute drive of the patient's residence.

Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study

Be willing and able to comply with all study procedures

Agree to meet all of the inclusion criteria throughout their participation in the study. Otherwise, the subject will be discontinued from the study

Be able to understand, speak, and read English sufficient for the completion of trial assessments

Exclusion Criteria

Current state of mania or psychosis, or have a history of mania or psychosis.

Treatment resistant depression.

Are diagnosed with vitamin or hormonal deficiencies that may mimic mood disorders, as determined by the investigator.

Be currently receiving any other interventional therapy for MDD other than a stable regimen of antidepressants or psychotherapy as defined in the inclusion criteria or have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain stimulation.

Have moderate or greater suicidality risk, or an attempt of suicide during lifetime or any previous hospitalization for suicidal behavior.

Diagnosis of sleep apnea with prescribed treatment (unless they are on CPAP treatment and are compliant with treatment) or a diagnosis of insomnia that is unrelated to depression, as determined by the investigator.

Have any structural lesion or any neurocranial defect or any other clinically significant abnormality that might affect safety, study participation, or confound interpretation of study results, as determined by the investigator.

Have any implant in the brain (e.g., DBS) or neurocranium, or any other active implantable medical device anywhere in the body (e.g. pacemaker, insulin pump).

Have a history of epilepsy or seizures.

Have shrapnel or any ferromagnetic material in the head.

Have any disorder that would impair the ability to complete the study questionnaires.

Have been diagnosed with autism spectrum disorder.

Have an alcohol use disorder or substance use disorder (past 12 months).

Have a cognitive impairment (including dementia).

medications that affect cortical excitability, as determined by the investigator.

Have ever taken esketamine / ketamine for treatment of depression.

Are currently admitted or have ever been admitted to a dedicated psychiatric ward for depression for a period of more than 24 hours.

Have ever been diagnosed with obsessive-compulsive disorder (OCD) or bipolar type 1 or 2 disorder.

Be diagnosed with PTSD, agoraphobia, anorexia or bulimia, panic or personality disorder, with active symptoms, based on the investigator's judgment.

Have any history of myocardial infarction, coronary artery bypass graft (CABG), coronary heart failure (CHF), or history of other cardiac issues.

Be currently experiencing or have a history of intractable migraines.

Be a chronic nicotine user.

Be currently pregnant or breastfeeding or planning to become pregnant or breastfeed any time during the study, or lack a medically acceptable method of contraception in females with child-bearing potential.

Be currently incarcerated.

Be participating concurrently in another clinical investigation or have participated in a clinical investigation within the last 90 days or intend to participate in another clinical investigation during the study.

Have a hairstyle or hair type, such as very thick hair or voluminous hairstyle, that would prevent wearing of the treatment cap tightly enough on the head that the electrodes are held close to the scalp.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT06976697) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Major Depressive Disorder (MDD) Treatment Options in Boston, MA

If you're searching for major depressive disorder (mdd) treatment options in Boston, MA, this clinical trial (NCT06976697) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced major depressive disorder (mdd) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all major depressive disorder (mdd) clinical trials near you to find additional studies recruiting in your area.

Major Depressive Disorder (MDD) Clinical Trial in Boston, MA

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