The objective for this study is twofold. The primary objective of the present study is to assess efficacy of DBS in the nucleus accumbens for patients with refractory MDD. Secondary objectives are the evaluation of long term efficacy and…
ID
Source
Brief title
Condition
- Psychiatric disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
* 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)
Background summary
In any given 1-year period, 5.8 percent of the Dutch population suffer from
Major Depressive Disorder (MDD). The economic cost for this disorder is high,
but the cost in human suffering cannot be estimated. MDD often interferes with
normal functioning and causes pain and suffering not only to those who have a
disorder, but also to those who care about them. Serious MDD can destroy family
life as well as the life of the ill person. A recent World Health Organization
report predicts that MDD will be the leading cause of disability and premature
death in the industrial world by the year 2020. Without treatment, ten percent
of people suffering from severe MDD commit suicide. With adequate treatment,
the majority of patients with this illness recover. Treatment resistant or
*refractory* MDD in its broadest sense still characterizes a significant number
of patients in therapy. There are individuals (up to 15% of patients) for whom
multiple interventions will be unhelpful and who will have significant
depression despite aggressive pharmacologic and psychotherapeutic approaches.
Presently there is anecdotal evidence that DBS is effective in patients with
refractory MDD.
Study objective
The objective for this study is twofold. The primary objective of the present
study is to assess efficacy of DBS in the nucleus accumbens for patients with
refractory MDD. Secondary objectives are the evaluation of long term efficacy
and tolerability of DBS for patients with therapy refractory MDD.
Study design
A randomized double blind, two-phase cross-over design.
Intervention
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 optimized by the psychiatrist during this period.
Optimization will be based on the changes in severity assessed with the
Hamilton Depression rating scale (HDRS) and the Montgomery-Asberg depression
rating scale (MADRS). If necessary, adjustment will be made every week for a
period of up to 3 months. Contact combinations with the best treatment outcome
will be used in the subsequent double-blind phase.
After initial stimulation optimalization patients enter the two weeks cross
over phase.P atients are randomly allocated to two periods of two weeks with
the stimulators in the *on* position in one period and in the *off* position in
the other. The order of these periods is randomly assigned. The psychiatrist
responsible for the treatment will turn the stimulator *on* or *off* .
The maintenance phase consists of a period of 1 year following the blind
assessment phase. During the maintenance period patients will be invited to
join a (cognitive) behavioural therapy (BT) program .
Study burden and risks
Exept for this small chance on negative concequences of the operation
(hemorrhage and/ or infections) , there are no serious risks associated to this
study. Futhermore DBS has a relatively less invasive and reversible nature of
DBS in comparison to current psychosurgery. Advantages to the subjects can be
expected because of the potential therapeutic effect (faster reduction in
OCD-symptoms) otherwise not obtained because of lack of response to current
treatment methods.
Meibergdreef 5
1105 AZ Amsterdam
NL
Meibergdreef 5
1105 AZ Amsterdam
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24312.018.08 |