CLINICAL TRIAL

Transcranial Magnetic Stimulation (TMS) for Melancholia

Waitlist Available · 18+ · All Sexes · Charleston, SC

EEG Synchronized TMS Trial for Depression

See full description

About the trial for Melancholia

Eligible Conditions
Depression · Depressive Disorder

Treatment Groups

This trial involves 2 different treatments. Transcranial Magnetic Stimulation (TMS) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Transcranial Magnetic Stimulation (TMS)
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Transcranial Magnetic Stimulation (TMS)
DEVICE

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Magnetic Stimulation (TMS)
2018
Completed Phase 4
~400

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
No current Vagus Nerve Stimulation
No contraindication to rTMS (history of neurological disorder or seizure (except induced by ECT), increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for >15 minutes, implanted electronic device, metal in the head, or pregnancy)
Pretreatment Hamilton score ≥ 20
Age between 21 and 70 years
Moderate level of resistance to antidepressant treatment in the current episode, defined as failure of 1-4 adequate medication trials or intolerance to at least 3 trials, and duration of current episode ≤ 3 years
No history of schizophrenia, schizoaffective disorder, other [non mood disorder] psychosis, depression secondary to a medical condition, mental retardation, substance dependence or abuse within the past year (except nicotine), bipolar disorder, psychotic features in this or previous episodes, amnestic disorder, dementia or MMSE ≤24, delirium, obsessive compulsive disorder, post-traumatic stress disorder, panic disorder
No history of failing to respond to an adequate course of ECT in this or any episode, and no ECT within the past 3 months
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At the 4th week of treatment (or 6 weeks in those who continue to 6 weeks).
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At the 4th week of treatment (or 6 weeks in those who continue to 6 weeks)..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Transcranial Magnetic Stimulation (TMS) will improve 1 primary outcome and 2 secondary outcomes in patients with Melancholia. Measurement will happen over the course of At each treatment session and progressively over the 30 sessions.

EEG phase synchronization
AT EACH TREATMENT SESSION AND PROGRESSIVELY OVER THE 30 SESSIONS
EEG phase synchronization will be assessed by collecting realtime EEG, and then calculating whether the person's EEG frequency changed after the first few pulses in the train to where the EEG then matches the TMS pulses exactly and all TMS pulses are delivered at precisely the same time in the EEG cycle.
Remission Rate
AT THE 4TH WEEK OF TREATMENT (OR 6 WEEKS IN THOSE WHO CONTINUE TO 6 WEEKS).
Depression Remission, as defined by the Hamilton Rating Scale for Depression, 24 item, score less than 10
EEG-TMS-fMRI Bold changes in cingulate cortex
AT THE 4TH WEEK OF TREATMENT (OR 6 WEEKS IN THOSE WHO CONTINUE TO 6 WEEKS).
EEG-TMS-fMRI Bold changes in cingulate cortex. We will measure the BOLD fMRI changes that are caused by a TMS pulse over the prefrontal cortex, and determine whether they increase more after 4 weeks of therapy.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of melancholia?

The presentation of melancholia varies depending on the age of presentation in the early years of life. Some of the common symptoms of this syndrome in childhood are anhedonia, lethargy, and poor concentration and sleeping. These symptoms can be noticeable between 3 and 6 years of age. As adolescence is a significant time period in human life, the majority of people between 12 and 25 years of age will exhibit a depressive mood and most will have some degree of mood disturbance during this period of life with prevalence exceeding 5%.

Anonymous Patient Answer

What causes melancholia?

Melancholia has been described as a psychiatric syndrome resembling major depression from the ancient Greek word, melanoukha, meaning blackness or sadness. It has been argued that melancholia was, in fact, a mood disorder due to its early onset in teens. In contrast, the present study provides evidence that melancholia is a more benign form of depression.

Anonymous Patient Answer

What is melancholia?

Melancholia is a mood disorder that can affect anyone irrespective of their age. It can lead people to become withdrawn and lose touch with their thoughts, feeling anxious and depressed. The onset of melancholia is often difficult to determine.\n

Anonymous Patient Answer

How many people get melancholia a year in the United States?

Melancholia is relatively common, at least in primary care settings; however, the incidence is lower than previously reported. This may be due to the difficulty in diagnosing melancholia at the primary care level, particularly when there is no known psychiatric history.

Anonymous Patient Answer

What are common treatments for melancholia?

Treatments with tricyclic antidepressants, lithium and antidepressant monotherapy are recommended by many sources. These have been established as effective in lowering depressive symptoms and improving quality-of-life in patients with MDD. Many studies are in progress in order to find the most likely treatment for MDD. While the evidence supports these agents for the treatment of MDD, they do not have a precise mechanism of action in treating this disorder and the efficacy, safety, and tolerability of these agents are unclear. However, most treatments currently used for depression are basically a combination of one or more of tricyclic and monotherapy antidepressants.

Anonymous Patient Answer

Can melancholia be cured?

The melancholic mood disturbance is strongly correlated with somatization of pain (i.e. dyspeptic symptoms). The occurrence of somatization was not affected by the psychiatric treatment.

Anonymous Patient Answer

Is transcranial magnetic stimulation (tms) safe for people?

tms is not associated with serious adverse events for healthy young adults. Previous reports involving older people did not include healthy young adults and the likelihood of events.

Anonymous Patient Answer

Does transcranial magnetic stimulation (tms) improve quality of life for those with melancholia?

Findings from a recent study, combined with the high rate of antidepressant use, are surprising. They further suggest that the effects of antidepressant medication on the QoL of patients are not mediated.

Anonymous Patient Answer

What are the common side effects of transcranial magnetic stimulation (tms)?

TMS is well tolerated and is free of acute side effects; however, long-term data are lacking. The side effects reported here are in line with other studies that reported that TMS causes few side effects. It is possible to prevent some side effects by applying pre-defined dosing guidelines, a strategy probably most practical in clinical studies.

Anonymous Patient Answer

How serious can melancholia be?

Although there are common symptoms between major depression and melancholia, this is not enough for it to be clinically considered to be melancholia. In a recent study, findings, only 1/1,400 people who fulfilled ICD-10 diagnosis criteria of melancholia were included.

Anonymous Patient Answer

What does transcranial magnetic stimulation (tms) usually treat?

Transcranial magnetic stimulation has been used to treat various disorders in which a pathologic disorganization of the brain-mind relationship has been thought to play a role, usually resulting from neurosis and psychopathology. There are many anecdotal reports of positive effect using this tool but there was no scientific study showing such effect. In psychiatric practice TCMS has shown to have some efficacy in the treatment of anxiety and psychotic disorders but is not well-defined for depression. It should be included in the list of the treatments that can be explored using TMS in order to better define the indications for this technique.

Anonymous Patient Answer

What is the latest research for melancholia?

The majority of published studies in this category (about 80%) are of low quality. Given the limited clinical experience of some clinicians with melancholia, there is the potential that these treatments are underused, which could account for the lack of consistent effectiveness in clinical practice and highlight the need for well-designed clinical trials.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Melancholia by sharing your contact details with the study coordinator.