Stimulation-ON for Melancholia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California, San Francisco, San Francisco, CA
Melancholia+3 More
Stimulation-ON - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Closed-Loop Deep Brain Stimulation for Major Depression

See full description

Eligible Conditions

  • Melancholia
  • Major Depressive Disorder (MDD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Melancholia

Study Objectives

This trial is evaluating whether Stimulation-ON will improve 1 primary outcome, 5 secondary outcomes, and 5 other outcomes in patients with Melancholia. Measurement will happen over the course of The Inventory of Depressive Symptomatology Self-Report (IDS-SR) score will be administered at Weeks 0, 6, and 12 of Stage 3.

Year 1
The number of patients for whom responsive neurostimulation (RNS) is a viable system to treat depression
Month 6
Biomarker identification in Stage 1
Stimulation site identification
Year 1
Number of patients who had viable biomarker(s) identified in Stage 2
Year 2
The number and type of serious adverse events for patients that occur in closed-loop deep brain stimulation with the device
Week 0
The difference in Hamilton Depression Rating Scale (HAMD-17) score
Week 36
The difference in Hamilton Depression Rating Scale (HAMD-17) score after 1 year
Week 0
The difference in the Inventory of Depressive Symptomatology Self-Report (IDS-SR) score
Week 36
The difference in Inventory of Depressive Symptomatology Self-Report (IDS-SR) score after 1 year
Week 0
The change in Montgomery Asberg Depression Rating Scale (MADRS) score
Week 36
The change in Montgomery Asberg Depression Rating Scale (MADRS) score after 1 year

Trial Safety

Safety Progress

1 of 3

Other trials for Melancholia

Trial Design

2 Treatment Groups

Arm 1: Intervention (stimulation ON)
1 of 2
Arm 2: Control (stimulation OFF)
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 12 total participants across 2 different treatment groups

This trial involves 2 different treatments. Stimulation-ON 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 in Phase 1 & 2 and have already been tested with other people.

Arm 1: Intervention (stimulation ON)
Device
This is a crossover trial. Each patient will receive 6 wks of stimulation ON (arm 1) and stimulation OFF (arm 2) in random order. After 6 months of intervening therapy, this 2-period crossover study will be repeated.
Arm 2: Control (stimulation OFF)
Device
This is a crossover trial. Each patient will receive 6 wks of stimulation ON (arm 1) and stimulation OFF (arm 2) in random order. After 6 months of intervening therapy, this 2-period crossover study will be repeated.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed at the final study visit of stage 3 (1 year duration)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly assessed at the final study visit of stage 3 (1 year duration) for reporting.

Who is running the study

Principal Investigator
K. S.
Katherine Scangos, Principal Investigator
University of California, San Francisco

Closest Location

University of California, San Francisco - San Francisco, CA

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
Age 22-70
Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for Major Depressive Disorder (MDD) without psychosis based on a Structured Clinical Interview for DSM-V (SCID) with current episode ≥ 2 years that is treatment- resistant (4 adequate trials (including ECT), 3 classes of medications, one augmentation strategy, psychotherapy) as measured by the antidepressant treatment history form (ATHF).
Failed electroconvulsive therapy (ECT) due to inability to achieve sustained response (2 failed attempts to discontinue ECT treatment) or discontinued due to intolerable side effects.
Has MADRS score of > 26 at both baseline and screening visit
The presence of variability on repeated administrations of MDD rating scales (minimum of 2-point variation on the HAMD-6 administered 3 times a day for 3 days), which is required for the identification of a neural biomarker.
If patient is on a regimen of psychotropic medication, no changes in this regimen should be made during the 4 weeks prior to entry into and the duration of the study.
Willing and able to undergo invasive brain recording/stimulation study
Willing and able to attend multiple research visits and perform at-home research protocol
Willing and able to provide informed consent
Ability to speak and read English

Patient Q&A Section

What are the latest developments in stimulation-on for therapeutic use?

"Stimulation-on is a new treatment for depression using the electroconvulsive therapy (ECT), that offers more freedom for treatment, and is safer and easier to use.\n" - Anonymous Online Contributor

Unverified Answer

What causes melancholia?

"Melancholia is a mental illness with major depressive disorder. Many factors such as genetics, mood disorders, and environmental exposure can be the cause of melancholia." - Anonymous Online Contributor

Unverified Answer

What is melancholia?

"Melancholia has traditionally been defined in the context of the psychiatric disorders depression and panic attacks, and not as a distinct mood-state characterized by abnormally low mood, anxiety and disinhibition, that is the present definition of what is termed'mood disturbances'. This article defines the mood state termed'melancholia' independently of its current psychiatric classification. Melancholia is characterized by abnormally low mood, anxiety, and hypersomnia, features which are observed in some clinical populations, in a minority of individuals who present with these symptoms. The features of melancholia can be associated with and are frequently preceded by a low mood state that is often termed 'depression'." - Anonymous Online Contributor

Unverified Answer

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

"About 5% of adults aged 19 years and above receive treatment for MDD annually, and about 5% of people with MDD are treated annually in US primary care for panic disorder--an overlap that might increase treatment costs. Given the number of patients who would benefit from treatment, screening and treatment of MDD before onset of panic symptoms is highly cost-effective." - Anonymous Online Contributor

Unverified Answer

What are the signs of melancholia?

"Symptoms like decreased libido, increased anxiety and sleep disturbances, insomnia, loss of interest in activities, weight loss and overeating and an increased number of psychotic episodes are clear signs of melancholia." - Anonymous Online Contributor

Unverified Answer

What are common treatments for melancholia?

"Most of the patients reported using antidepressant treatment for a protracted period of time in their life (almost continuously), and the most popular type of antidepressants (SSRIs and TCAs) were prescribed for treatment with a long follow-up. This has not been previously reported in the literature, so it can be assumed that our findings are representative. In a recent study, findings indicates common treatments for melancholia and highlights the use of a group of medications in the first group of patients (TCA, SSRI, or two-group treatment)." - Anonymous Online Contributor

Unverified Answer

Can melancholia be cured?

"The remission rate in patients with severe depression does not differ significantly from the rate of remission in the patients with chronic depression in other studies. Thus, the only meaningful question is whether or not patients can remain free of a depressive syndrome. Most patients can stay free of a depressive syndrom, usually for life." - Anonymous Online Contributor

Unverified Answer

How serious can melancholia be?

"In a group of patients at low risk for suicide and with limited exposure from the health care system to the psychological distress of mental illness, depressive symptoms in women appeared serious in the context of their overall mental health." - Anonymous Online Contributor

Unverified Answer

What does stimulation-on usually treat?

"Recent findings showed the effectiveness of SSRIs and tricyclic antidepressants in the treatment of depressive disorders, which support our previous study. It also supports the previous findings that antidepressants show effect in treatment of anxiety and stress disorders, especially when taken after the onset of medical issues. Moreover, these drugs could prove effective in the treatment of panic attacks that are induced by medical issues." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating melancholia?

"[There have been some recent advances in understanding the mechanisms of depression and our conceptualizations of it, as well as treatments for a more rational, tailored approach to treatment than for traditional psychotherapy and medication." - Anonymous Online Contributor

Unverified Answer

How does stimulation-on work?

"One third of women in our sample had problems stopping and starting DST. The effects of DST on mood and anxiety were similar to the placebo group of women who stopped DST. The effects of DST in reducing heart rate and blood pressure were greater than placebo. The data did not support claims that DST has a psychological effect on reducing stress or reducing mood disorders. Because the study was single-blind and there were not enough participants for a significant interpretation of any effect size estimates. Additional research is needed not only in this group to more fully understand how DST operates, but also in clinical settings where DST has been used in treating stress-related disorders in children and adolescents." - Anonymous Online Contributor

Unverified Answer

What is stimulation-on?

"Results from a recent paper indicated a significant positive effect of acute (short-term) administration of VSO on symptoms and psychometric characteristics of depression in this group of bipolar patients. Based on the observed and predicted effects of VSO and on reports from others demonstrating it does not have addictive characteristics, there is also evidence that VSO may be an alternative or at least adjunct antidepressant-like treatment in bipolar depression. The data also indicate it may be useful as a therapeutic option in other disorders besides depression in other areas of medicine. In addition, these findings suggest there is a need for more high-quality clinical trials of VSO in bipolar disorder to evaluate the reliability of the present pilot results." - Anonymous Online Contributor

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