Status:
TERMINATED
DBS of the Habenula for Treatment- Resistant Major Depression
Lead Sponsor:
Ruijin Hospital
Conditions:
Treatment Resistant Major Depression Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 st...
Eligibility Criteria
Inclusion
- 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.
- 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；
Exclusion
- 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;
- 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;
Key Trial Info
Start Date :
November 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03347487
Start Date
November 13 2017
End Date
May 30 2021
Last Update
June 9 2021
Active Locations (1)
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1
Shanghai Ruijin Hospital Functional Neurosurgery
Shanghai, Shanghai Municipality, China, 200025