AzTrials
AzTrials

Treatment Resistant Major Depression DisorderNCT03347487

DBS of the Habenula for Treatment- Resistant Major Depression

A study testing Deep brain stimuation system implantation in people with Treatment Resistant Major Depression Disorder, run by Ruijin Hospital at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The habenula(Hb) is an epithalamic structure located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions. An increasing number of studies indicates that overactivity in the lateral habeluna(LHb) is present during depressed states, where it could drive… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Deep brain stimuation system implantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteChina
Study dates
13 Nov 2017to 30 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women(non-pregnant) aged 18-65 years old;
  • DSM-5 diagnosis (assessed by Structured Clinical Interview for DSM-5) of a current major depressive episode(MDE), either nonpsychotic unipolar major depressive disorder (MDD) or bipolar disorder (BD);
  • Chronic illness with current MDE ≥ 24 months duration and/or recurrent illness with at least a total of 4 lifetime episodes (including current episode ≥ 12 months) and a minimum of 5 y since the onset of the first depressive episode;
  • For subjects with a bipolar disorder: the last manic or hypomanic episode must have been ≥ 24 months before study enrollment and patients must be maintained on a mood stabilizer (e.g. lithium or another mood stabilizer approved for bipolar disorder)
  • Treatment resistance defined as Failure of at least 3 adequate treatments from at least two distinctly different classes (SSRI, SNRI, NaSSA, TCA+, lithium-addition) for a period of 6-8 weeks. If diagnosed as bipolar, failure to respond to (or inability to tolerate) a minimum of three treatments approved for bipolar disorder, including lithium and at least one medication FDA-approved for bipolar depression (e.g., olanzapine/fluoxetine combination, quetiapine, lurasidone).
  • At least 1 session of ECT, for which the series of ECT was terminated either due to adverse effects or insufficient response (including at least 6 sessions of bilateral ECT). Or unable to recieve ECT.
Show all 11Show fewer
  • Symptom Severity: HAMD-17 total ≥21;
  • Stable antidepressant medical regimen for the month preceding surgery;
  • Anticipates a stable psychotropic medication regimen in the next 12 months;
  • Able and willing to give written informed consent;
  • Modified mini-mental state examination (MMSE) score ≥ 27；

Who cannot join

  • Schizophrenia /history of psychosis unrelated to MDD;
  • Severe personality disorder (assessed by SCID-II);
  • Alcohol or substance abuse/dependence within 6 months, excluding nicotine dependence;
  • Current substantial suicidal risk as defined by a plan or clear immediate intent for self-harm, or had a serious suicide attempt within the last year;
  • Neurological disease (e.g., Parkinson's disease)
  • Any history of seizure disorder or hemorrhagic stroke;
Show all 12Show fewer
  • Abnormal brain MRI ;
  • Previous sterosurgery;
  • Any medical contraindication to surgery;
  • Does not have adequate family/friend support as determined by psychological screening and/or interview;
  • Unable to maintain a stable psychotropic medication regimen in the next 12 months;
  • Pregnant or has plans to become pregnant in the next 12 months;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Ruijin Hospital Functional Neurosurgery

    Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

Official title: Deep Brain Stimulation of the Bilateral Habenula for Treatment- Resistant Major Depression: An Open Label Pilot Trial

The habenula(Hb) is an epithalamic structure located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions. An increasing number of studies indicates that overactivity in the lateral habeluna(LHb) is present during depressed states, where it could drive the changes in midbrain activity linked to depression. Deep brain stimulation(DBS) of the major afferent bundle (i.e., stria medullaris thalami) of the LHb can treat treatment-resistant major depression(TRD). There is no clinical case of directly stimulating habeluna for treatment TRD. This research will investigate effectiveness and safety of bilateral DBS to habenula for patients with TRD. This study will also use structural and functional MRI to explore the underlying mechanism of Hb's effects on TRD.

Being tested
Deep brain stimuation system implantation
Keywords
Bilateral Habenula, Treatment Resistant Major Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deep brain stimuation system implantationProcedure or surgery

    Also called DBS, Activa RC System

    All subjects will receive bilateral surgical implantation of DBS system.The Medtronic DBS 3389 electrode is utilized in this study. The DBS system includes a dual-channel neurostimulator kit, lead kit, extension kit, clinician-operated wireless programmer, test stimulator, and patient controller.

Study groups in NCT03347487
Study groupRoleWhat they receive
Deep Brain Stimulation of Bilateral HabenulaExperimentalNot described
Receives: Procedure: Deep brain stimuation system implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. changes in the Hamilton Depression Scale(HAMD-17) score from baseline to 9 months

    The score of the scale ranges from 0 to 50.

    Measured: Baseline (preoperative),one month, 3 months, 6 months, 9 months

  2. changes in the Montgomery-Asberg Depression Rating Scale from baseline to 9 months

    The score of the scale ranges from 0 to 60.

    Measured: Baseline (preoperative),one month, 3 months, 6 months, 9 months

Secondary outcomes (13)

  1. changes in the brain activity

    Measured: Baseline (preoperative),one month, 9 months

  2. Side Effects

    Measured: Baseline (preoperative),one month, 3 months, 6 months, 9 months

  3. Young Mania Rating Scale (YMRS)

    YMRS is an eleven-item multiple choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes. The score of the scale ranges from 0 to 60. Higher score means more severity of mania.

    Measured: Baseline (preoperative),one month, 3 months, 6 months, 9 months

  4. Changes in Hamilton Anxiety Scales(HAMA)

    Clinician administered assessment.The score of the scale ranges from 0 to 56.

    Measured: Baseline (preoperative),one month, 3 months, 6 months, 9 months

  5. Global Assessment of Functioning Scale(GAF)

    Clinician administered assessment.The score of the scale Scores range from 100 (extremely high functioning) to 1 (severely impaired).

    Measured: Baseline (preoperative),one month, 3 months, 6 months, 9 months

  6. Columbia Suicide Severity Rating Scale (C-SSRS)

    Clinician administered assessment.The Screener contains 6 "yes" or "no" questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide over the past month and behaviors over their lifetime and past 3 months. Each question addresses a different component of the respondent's suicide ideation severity and behavior.

    Measured: Baseline (preoperative),one month, 3 months, 6 months, 9 months

  7. Changes in Beck Depression Inventory

    Self-rating scale. The score of the scale ranges from 0 to 63. Higher score means more severity of depression.

    Measured: Baseline (preoperative),one month, 3 months, 6 months, 9 months

  8. Chang in Pittsburgh Sleep Quality Index

    The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score ranging from 0 to 21. The high score means poor quality of sleep.

    Measured: Baseline (preoperative),one month, 3 months, 6 months, 9 months

  9. World Health Organization Quality of Life-BREF(WHO-BREF)

    The World Health Organization Quality of Life - BREF (WHOQOL-BREF) is a self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment. It contains 26 items which is a 5 points scale. The higher score means better quality of life.

    Measured: Baseline (preoperative),one month, 3 months, 6 months, 9 months

  10. the MOS item short from health survey (SF-36)

    SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. The higher score means better quality of life.

    Measured: Baseline (preoperative),one month, 3 months, 6 months, 9 months

  11. Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form

    The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are stand-alone items. The raw total score ranges from 14 to 70.

    Measured: Baseline (preoperative),one month, 3 months, 6 months, 9 months

  12. Sheehan Disability Scale

    Self-rating scale. The SDS is a composite of three self-rated items designed to measure the extent to which three major domains in the patient's life are functionally impaired by psychiatric or medical symptoms. The SDS assesses functional impairment in three major life domains: work, social life/leisure activities, and family life/home responsibilities. The higher scores mean more severity of disability.

    Measured: Baseline (preoperative),one month, 3 months, 6 months, 9 months

  13. Changes in Neuropsychological measures(Scores of CANTAB tasks)

    Neuropsychological measures contains six tasks which are Stop Signal Task, Spatial Working Memory, Paired Associated Learning, Stocking of Cambridge, Intra Extra dimensional Set Shifting, Reaction time Task

    Measured: Baseline (preoperative),3 months, 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2017
  2. Study start13 Nov 2017
  3. Primary completion30 May 2021
  4. Study completion30 May 2021

Why it stopped: 7 patients were included in this study which aimed for 13 participants. Preliminary data were sufficient for developing further study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All subjects will receive bilateral surgical implantation of DBS system.
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03347487
Sponsor's protocol ID
2018 DBS-Hb MDD
Status last verified
Jun 2021
First submitted
11 Nov 2017
Last updated
9 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sartorius A, Kiening KL, Kirsch P, von Gall CC, Haberkorn U, Unterberg AW, Henn FA, Meyer-Lindenberg A. Remission of major depression under deep brain stimulation of the lateral habenula in a therapy-refractory patient. Biol Psychiatry. 2010 Jan 15;67(2):e9-e11. doi: 10.1016/j.biopsych.2009.08.027. No abstract available.

    PubMed 19846068

  • Sartorius A, Henn FA. Deep brain stimulation of the lateral habenula in treatment resistant major depression. Med Hypotheses. 2007;69(6):1305-8. doi: 10.1016/j.mehy.2007.03.021. Epub 2007 May 10.

    PubMed 17498883

  • Kiening K, Sartorius A. A new translational target for deep brain stimulation to treat depression. EMBO Mol Med. 2013 Aug;5(8):1151-3. doi: 10.1002/emmm.201302947. Epub 2013 Jul 4. No abstract available.

    PubMed 23828711

  • Dougherty DD, Rezai AR, Carpenter LL, Howland RH, Bhati MT, O'Reardon JP, Eskandar EN, Baltuch GH, Machado AD, Kondziolka D, Cusin C, Evans KC, Price LH, Jacobs K, Pandya M, Denko T, Tyrka AR, Brelje T, Deckersbach T, Kubu C, Malone DA Jr. A Randomized Sham-Controlled Trial of Deep Brain Stimulation of the Ventral Capsule/Ventral Striatum for Chronic Treatment-Resistant Depression. Biol Psychiatry. 2015 Aug 15;78(4):240-8. doi: 10.1016/j.biopsych.2014.11.023. Epub 2014 Dec 13.

    PubMed 25726497

  • Bergfeld IO, Mantione M, Hoogendoorn ML, Ruhe HG, Notten P, van Laarhoven J, Visser I, Figee M, de Kwaasteniet BP, Horst F, Schene AH, van den Munckhof P, Beute G, Schuurman R, Denys D. Deep Brain Stimulation of the Ventral Anterior Limb of the Internal Capsule for Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2016 May 1;73(5):456-64. doi: 10.1001/jamapsychiatry.2016.0152.

    PubMed 27049915

  • Huang Y, Sun B, Debarros J, Zhang C, Zhan S, Li D, Zhang C, Wang T, Huang P, Lai Y, Brown P, Cao C, Tan H. Increased theta/alpha synchrony in the habenula-prefrontal network with negative emotional stimuli in human patients. Elife. 2021 Jul 12;10:e65444. doi: 10.7554/eLife.65444.

    PubMed 34251338

Questions about this trial

What is this clinical trial studying?

A study testing Deep brain stimuation system implantation in people with Treatment Resistant Major Depression Disorder, run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: 7 patients were included in this study which aimed for 13 participants. Preliminary data were sufficient for developing further study.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

changes in the Hamilton Depression Scale(HAMD-17) score from baseline to 9 months (time frame: Baseline (preoperative),one month, 3 months, 6 months, 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03347487, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in