Deep brain stimulation of the medial forebrain bundle for patients with treatment-resistant depressio

Phase 3

Recruiting

• Conditions: depression; major depressive disorder; 10027946

• Registration Number: NL-OMON54601
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

1) Primary diagnosis: Major Depressive Disorder
2) Treatment-resistance defined as inadequate response to (or intolerable side
effects) of all of the following:
a. At least 2 adequately dosed treatments of at least two 2nd generation
antidepressants (SSRI, SNRI, NaSSA) for a period of 6-8 weeks
b. An adequately dosed treatment with a tricyclic antidepressant (TCA) for 6-8
weeks
c. TCA + addition of lithium when tolerable at least 6 weeks at therapeutic
drug levels (>0.6 mmol/L))
d. An adequately dosed treatment with a monoamine oxidase inhibitor OR >=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 patients who are kept stable with maintenance ECT, but who
relapse after discontinuation of this maintenance ECT are also eligible, but
need to fulfill all other inclusion criteria.

Besides the above defined treatments, we will evaluate the adequacy of all
attempted antidepressant treatments, including off-label strategies such as
esketamine. In case on- or off-label treatments are available to the patient,
but have not been tried adequately, these options are discussed with and
offered to the patient before offering deep brain stimulation.
3) HAM-D total >= 18
4) Illness duration > 2 years
5) Age: 20-75 years old

Exclusion Criteria

1) Bipolar Disorder
2) Schizophrenia /history of psychosis unrelated to MDD
3) Alcohol or substance abuse (including benzodiazepines) during last 6 months,
excluding nicotine use
4) Primary and severe personality disorder diagnosed independently from TRD
5) Explicit suicidal plans requiring hospitalization in a closed ward
6) Contraindications to have surgery
7) Depression as a result of acute brain damage (e.g. stroke / hemorrhage)
8) Parkinson*s disease, Tourette syndrome, dementia, epilepsy, tic disorder
9) Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Difference in scores between active and sham DBS on the Hamilton Depression<br /><br>Rating Scale, 17 items (HAM-D-17, range 0-52 with higher scores indicating more<br /><br>symptoms); </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Percentage of responders after the open label phase (defined as a >=50%<br /><br>reduction of the baseline HAM-D-17 score).<br /><br>Change over time of HAM-D score, MADRS score, and IDS-SR score.<br /><br>Adverse events.<br /><br>Change of cognitive functions (measured with neuropsychological tests), quality<br /><br>of life (using questionnaires), personality (using questionnaires), brain<br /><br>activity (MRI scans), and physical functioning.<br /><br>Acute changes before and after turning on DBS (measured with a diary).</p><br>