Major Depressive Disorder
Conditions
Interventions
Deep Brain Stimulation (for Explanation DBS see protocol 1.5
pag 6) in the
Nucleus Accumbens. After surgery, testing for optimal stimulation parameters
will be performed during a variable period ranging from 1-3 months. Stimulation
parameters will be optimiz
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Primary diagnosis: MDD (single episode or recurrent; 296.2 or 296.3) according to the DSM-IV criteria based on a psychiatric interview and the SCID as diagnostic instrument - Illness duration > 2 years, chronic MDD - HAM-D total above or equal : 18 (measured twice, at least two weeks apart with the last assessment just before surgery) - Disabling severity with substantial functional impairment according to the DSM-IV criterion C and a Global Assessment of Function (GAF) score of 45 or less - The level of impairment must have been persistent for at least 2 years - Age: 18-65 years old - Written informed consent - Able to fully understand the consequences of the procedure (IQ > 80) - Dutch or English speaking and able to answer the study questions - Capable to make his or her own choice without coercion - Treatment refractory defined as failure of: * At least 2 adequate treatments of at least two distinctly different classes of 2nd generation antidepressants (SSRI, SNRI, NaSSA) for a period of 6-8 weeks and * An adequate trial of a TCA 6-8 weeks (at therapeutic drug levels) and * TCA + addition of lithium when tolerable at least 6 weeks at therapeutic drug levels (>0.6 mmol/L)) and *An adequate trial of a MAOI and * *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 the above inclusion criteria
Exclusion criteria
Exclusion criteria: - Unstable physical condition - Organic cause - Parkinson*s disease, dementia, epilepsy - Schizophrenia /history of psychosis unrelated to MDD - Alcohol or substance abuse (including benzodiazepines) during last 6 months - Current Tic disorder - Antisocial personality disorder - Bipolar Disorder - Pregnancy - Mental retardation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Hamilton depression rating scale (HDRS) and the Montgomery Åsberg depression rating scale (MADRS). * Improvement is defined as a drop in HDRS or MADRS of 25*49% * Response is defined as *50% from baseline in HDRS or MADRS * Remission as HDRS *7 or MADRS *7. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Inventory for Depressive Symptoms (IDS-SR) * Hamilton Anxiety Scale (HAM-A) * Snaith-Hamilton Pleasure Scale (SHAPS) * Symptom Checklist 90 (SCL-90) * Quality of life enjoyment and satisfaction Questionnaire * Sheehan Disability Scale (SDS) * The Clinical Global Impression (CGI) | — |
Countries
Netherlands
Outcome results
None listed