CLINICAL TRIAL

Active TBS for Melancholia

1 Prior Treatment
Relapsed
Recruiting · 18+ · All Sexes · Toronto, Canada

This study is evaluating whether a brain stimulation technique can help people with opioid use disorder and major depressive disorder who are at risk for suicide.

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About the trial for Melancholia

Eligible Conditions
Opioid-Related Disorders · Substance-Related Disorders · Depressive Disorder, Major · Disease · Depressive Disorder · Major Depressive Disorder (MDD) · Opioid Use Disorder (OUD)

Treatment Groups

This trial involves 2 different treatments. Active TBS is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Active TBS
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Sham TBS
DEVICE

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Melancholia or one of the other 6 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
's instructions Can give informed consent and follow the instructions of the psychiatrist in charge of the brain stimulation research. show original
We are looking for people who are currently taking opioid agonist or antidepressant medications and have not made any changes to their dosages in the last 30 days show original
Between the ages of 18-60 years
The MINI interview confirmed that the person has opioid dependence and major depressive disorder. show original
The baseline score for suicidal ideation is four or higher on the scale. show original
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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: Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, after TBS treatment course (4 weeks), and at 1 month follow up.
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 Active TBS will improve 1 primary outcome and 5 secondary outcomes in patients with Melancholia. Measurement will happen over the course of Baseline, after TBS treatment course (4 weeks), and at 1 month follow up.

Timeline Followback Change
BASELINE, AFTER TBS TREATMENT COURSE (4 WEEKS), AND AT 1 MONTH FOLLOW UP
Self-reported substance use over a designated period of time. Min value = 0 Max value = N/A. Higher score = worse outcome.
BASELINE, AFTER TBS TREATMENT COURSE (4 WEEKS), AND AT 1 MONTH FOLLOW UP
Change in Columbia - Suicide Severity Rating Scale Change
CHANGE FROM BASELINE, TO END OF TBS TREATMENT COURSE (4 WEEKS), AND AT 1 MONTH FOLLOW UP
An interviewer-rated suicide risk assessment tool. Min value = 0, Max value = N/A. Higher score = worse outcome
CHANGE FROM BASELINE, TO END OF TBS TREATMENT COURSE (4 WEEKS), AND AT 1 MONTH FOLLOW UP
Visual Analogue Scale for Opioid Cravings Change
BASELINE, AFTER TBS TREATMENT COURSE (4 WEEKS), AND AT 1 MONTH FOLLOW UP
A rating scale for subjective cravings to use opioids. Min value = 0 Max value = 100. Higher score = worse outcome.
BASELINE, AFTER TBS TREATMENT COURSE (4 WEEKS), AND AT 1 MONTH FOLLOW UP
17-item Hamilton Rating Scale for Depression (HRSD-17) Change
BASELINE, AFTER TBS TREATMENT COURSE (4 WEEKS), AND AT 1 MONTH FOLLOW UP
A rating scale for measuring severity of depressive symptoms. Min value = 0 Max value = 52. Higher score = worse outcome
BASELINE, AFTER TBS TREATMENT COURSE (4 WEEKS), AND AT 1 MONTH FOLLOW UP
Change in Scale for Suicidal Ideation Remission
CHANGE FROM BASELINE, TO END OF TBS TREATMENT COURSE (4 WEEKS), AND AT 1 MONTH FOLLOW UP
A semi-structured interview for assessing suicidal ideation, min value=0, max value = 38. Higher score = worse outcome.
CHANGE FROM BASELINE, TO END OF TBS TREATMENT COURSE (4 WEEKS), AND AT 1 MONTH FOLLOW UP
Change in Scale for Suicidal Ideation Change
CHANGE FROM BASELINE, TO END OF TBS TREATMENT COURSE (4 WEEKS), AND AT 1 MONTH FOLLOW UP
A semi-structured interview for assessing suicidal ideation, min value=0, max value = 38. Higher score = worse outcome.
CHANGE FROM BASELINE, TO END OF TBS TREATMENT COURSE (4 WEEKS), AND AT 1 MONTH FOLLOW UP

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 latest developments in active tbs for therapeutic use?

Results from a recent clinical trial of these studies are encouraging and could be combined with existing knowledge to lead to a better understanding of the causes and therapies for Tourette's and to develop more effective therapies targeting tics.

Anonymous Patient Answer

How serious can melancholia be?

The condition of melancholy in the elderly should be taken seriously. Serious psychiatric abnormalities including psychotic disorders and other severe symptoms could develop. Early recognition should allow the establishment of appropriate preventive and therapeutic strategies.

Anonymous Patient Answer

What is melancholia?

The defining characteristics of melancholia are sadness and sadness with affect but no thoughts of suicide. The melancholic person's mood swings, which occur with periods of depressed mood and periods of mood hyperarousal, are often the focus of attention by clinicians and the patient's family, and their interpretation of the patient's mood may lead to the misdiagnosis and undertreatment of depression. Patients may experience their depressive episodes in the morning, at night, or during each day. Most often, they experience depressive periods when their mood is elevated, and they have mood-neutral periods when they feel depressed. In some cases, this cycling of mood may be unremitting and unrelenting.

Anonymous Patient Answer

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

1.5 million people aged 15 years or older develop a mood disorder on a year.\nquestion: How many people get depression annually in the United States? answer: By age and gender, 2-4 million people meet criteria for depression on a year. By socioeconomic class and race, disparities exist.

Anonymous Patient Answer

Can melancholia be cured?

There were a small number of cases where patients were able to attain full remission while continuing to take antidepressants, although the median time to remission was short, between 0 and 8 months. There are currently no controlled trials that support the remission of major depression by discontinuing antidepressants. Moreover, the remission is not permanent or guaranteed. The lack of controlled trials in the field of depression has led to the belief that there isn’t any specific treatment for depression. However, the majority of cases of treatment have been reported to be successful on discontinuation of antidepressants. Patients have reported full or partial remission upon discontinuation of antidepressants; albeit, these cases have been reported to be transient.

Anonymous Patient Answer

What causes melancholia?

The causes of depression have been variedly believed to be due to a number of reasons including genetic predisposition and environmental factors. The two hypotheses can also be considered as separate concepts. Genetic predisposition seems to affect depression risk mainly in women and in first-episode depression and more than the other factors. The stressful environments such as parental unemployment can also cause depression. It has also been suggested that there is no single mechanism that determines if a depressive episodes becomes melancholic, if not all depression becomes melancholic. Moreover, not all the depression cases are melancholic in character. The current study supports the hypothesis that depressive episodes are not all melancholic.

Anonymous Patient Answer

What are common treatments for melancholia?

This checklist could assist clinicians when interviewing patients and when assessing treatments in the clinic. Although there were several common treatments for depression, the most common treatments were antidepressants. There was little evidence of the clinical effectiveness of cognitive-behavioural therapy (CBT) for the other disorders. More research is needed to determine if CBT can be used as a sole treatment for depressive disorders.

Anonymous Patient Answer

What are the signs of melancholia?

Melancholia involves poor motivation, increased appetite, increased sleepiness, and lowered energy, as well as increased fatigue and depression. It may also involve feelings of hopelessness and helplessness. There is also an inability to work.\n

Anonymous Patient Answer

Has active tbs proven to be more effective than a placebo?

The efficacy of active M. tb on depressive depression did not differ significantly from that of a placebo. This result is in line with literature about M. tb treatment and mood. However, our study revealed that M. tb appears to be more effective than a placebo in anxiety, however, a larger sample may be needed to confirm this.

Anonymous Patient Answer

What is active tbs?

Attention deficit hyperactivity disorder is a common psychopathology in depressed persons. There is some evidence that tbs is related to negative emotional experiences. In light of the previous studies, these data support the hypothesis that tbs and/or anxiety could be pathogenic factors in both depressive and hyperactive symptoms. The pathogenesis of tbs remains unclear.

Anonymous Patient Answer

Is active tbs safe for people?

People with major depression have similar symptoms and severity of depression to patients with active tb and are more likely to display symptoms of depression. Future clinical studies need to address whether treatments of depression should be targeted to active tb rather than depression in general.

Anonymous Patient Answer

Does active tbs improve quality of life for those with melancholia?

Both active tbs and usual tbs have an effect on QoL in melancholic depression. Active tbs treatment has greater effect on three QoL domains that are related to depressive symptoms, namely, 'emotional' and'social' functioning.

Anonymous Patient Answer
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