Deep Brain Stimulation in Treatment-refractory patients with Major Depressive Disorder; A pilot study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

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

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The Hamilton depression rating scale (HDRS) and the Montgomery Åsberg<br /><br>depression rating scale (MADRS).<br /><br>* Improvement is defined as a drop in HDRS or MADRS of 2549%<br /><br> Response is defined as 50% from baseline in HDRS or MADRS<br /><br> Remission as HDRS 7 or MADRS 7. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Inventory for Depressive Symptoms (IDS-SR)<br /><br>* Hamilton Anxiety Scale (HAM-A)<br /><br>* Snaith-Hamilton Pleasure Scale (SHAPS)<br /><br>* Symptom Checklist 90 (SCL-90)<br /><br>* Quality of life enjoyment and satisfaction Questionnaire<br /><br>* Sheehan Disability Scale (SDS)<br /><br>* The Clinical Global Impression (CGI)</p><br>

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