Major Depressive Disorder
Conditions
Interventions
Stereotactic implantation of bilateral DBS electrodes in the nucleus accumbens in the DBS group.
After an optimization period of 3 months (if necessary prolonged until 6 months), a double blind cros
Sponsors
Academic Medical Center (AMC) Amsterdam, NL
St Elizabeth Ziekenhuis Tilburg NL
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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; 2. Illness duration > 2 years, chronic MDD; 3. HAM-D total > 18; 4. 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; 5. The level of impairment must have been persistent for at least 2 years; 6. Age: 18-65 years old; 7. Written informed consent; 8. Able to fully understand the consequences of the procedure (IQ > 80); 9. Dutch or English speaking and able to answer the study questions; 10. Capable to make his or her own choice without coercion; 11. Treatment refractoriness defined as failure of: A. 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; B. An adequate trial of a TCA 6-8 weeks (at therapeutic drug levels), and; C. TCA + addition of lithium when tolerable at least 6 weeks at therapeutic drug levels (>0.6 mmol/L), and; D. An adequate trial of a MAOI, and; E. ≥6 sessions 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: F. 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: 1. Unstable physical condition; 2. Organic cause; 3. Parkinson’s disease, dementia, epilepsy; 4. Schizophrenia/ history of psychosis unrelated to MDD; 5. Alcohol or substance abuse (including benzodiazepines) during last 6 months; 6. Current Tic disorder; 7. Antisocial personality disorder; 8. Bipolar Disorder; 9. Pregnancy; 10. Mental retardation; 11. Participation in a SPECT study in the year prior to this study; 12. Standard MRI scan exclusion criteria (pregnancy, pacemaker and metals contraindicated for MRI except for the DBS implantation and stimulator itself); 13. The use of anticoagulants must be able to be stopped before surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study: 1. The Hamilton depression rating scale and the Montgomery Åsberg depression rating scale: A. Improvement is defined as a drop in HDRS or MADRS of 25–49%; B. Response is defined as ≥50% decrease from baseline in HDRS or MADRS; C. Remission as HDRS ≤7 or MADRS ≤7. Neuroimaging/neuropsychology study: 1. Changes in dopaminergic system; 2. Changes in activity in cortical-limbic-thalamic-striatal network; 3. Change in cognitive functioning before and after DBS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Main study: 1. Other efficacy measures: A. Inventory for Depressive Symptoms (IDS-SR); B. Hamilton Anxiety Scale (HAM-A); C. Snaith-Hamilton Pleasure Scale (SHAPS); D. Symptom Checklist 90 (SCL-90); E. Quality of life enjoyment and satisfaction Questionnaire and MOS SF36; F. Sheehan Disability Scale (SDS); G. The Clinical Global Impression (CGI). Neuroimaging/neuropsychology study: 1. Structural differences in cortical-limbic-thalamic-striatal network. | — |
Contacts
Public ContactD. Denys
PO Box 75867
Outcome results
None listed