To predict and evaluate the effectively and safety of ECT in depressed elderly.1. the relation between clinical parameters and the safety and effectively of ECT in elderly with a severe depressive disorder2. the relation between structural brain…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
clinical parameters predict safety and effect of ECT
MRI findings predict safety and effect of ECT
lack of cortisol response predicts response to ECT
BDNF increases after ECT and there is neurorestorement of hippocampal volume
genetic profile predicts clinical parameters and effect of ECT
Secondary outcome
there are no secundary study parameters
Background summary
Depressive disorders are more frequent in the elderly and have a poor prognosis
in terms of chronic or remittent course, co-morbidity with somatic diseases,
functional impairments and cognitive disorders, and increased mortality rates.
Therefore, insight in symptoms and prognosis of depressive disorder in the
elderly is of great importance. Several studies have shown that severe
depression with psychomotor, psychotic or vital symptoms are best treated with
tricylcic antidepressants (TCA) or ECT (Parker 2007). Identifying patients that
will respond to ECT will enable earlier conversion to TCA or ECT in de
treatment of depression. This is of great importance since longer index episode
predict worse outcome and early intervention may limit the number of ECT
sessions needed and thereby limit side-effects.
In January 2010 we will start on the ward with the systematic collection of
data on the patients treated with ECT. This is care as usual. The data will
collected anonymously and systematic for future analysis.
Study objective
To predict and evaluate the effectively and safety of ECT in depressed elderly.
1. the relation between clinical parameters and the safety and effectively of
ECT in elderly with a severe depressive disorder
2. the relation between structural brain abnormalities with MRI and the safety
and effectively of ECT in elderly with a severe depressive disorder
3. the relation between neuro-endocrine parameters and the safety and
effectively of ECT in elderly with a severe depressive disorder
4. the relation between genetic profile and effectively of ECT
in elderly with a severe depressive disorder
Study design
Patients included in the systematic and anonymously data of patients treated
with ECT will be asked to participate. They will be asked to give a separate
informed consent for the blood and saliva samples. 80 patients of 60 years and
over admitted to the clinical psychiatric ward with a severe depression,
confirmed by the MINI, will be asked to participate.
Patients will be informed by the psychiatrist or research assistant about the
research, written information will be given as well and patients will be asked
for a written informed consent.
Appointments for sample collection will be scheduled. Patients can participate
for blood, saliva or both.
BDNF
Blood (5cc, 1 tube) will be drawn, combined with blood draws indicated by the
clinic. There are 4 time-points, T0 before ECT, T1 after 6 ECT sessions, T2
after the last ECT session and T4 6 weeks after the last ECT session. In
several studies it was shown that BDNF was low in severely depressed patients
before treatment (T0) and increased after treatment (T3). The time-point T1 and
T2 are to possibly identify BDNF as predictor of response to ECT.
Genetic profile.
Blood will be drawn for BDNF, once red blood cells will be stored for genetic
profiling.
Cortisol
As a indicator of the stress response of the hypothalamic-pituary-adrenal axis
the morning curve cortisol is determined (Vreeburg et al, 2009) with saliva
samples at awakening, after 30 , 45 and 60 minutes (Wust et al. 2000) and the
circadian rhythm (additional sample at 22 en 23 hours). Saliva is collected by
chewing on cotton cloths. Saliva will be extracted from the cloths and stored
at -85*C for future research. Saliva will be collected at two time points,
before ECT (T0) and after the last ECT (T2).
Study burden and risks
The patients included are admitted with a severe mood disorder, therefore the
nature and extent burden for the participants will be limited. Blooddraws will
be combined with blooddraws indicated by the treating psysician as part of
patient care. The cortisol measurements will include chewing on cotton supplied
by the nurse on the ward and are with little burden in the patient. None of the
interventions are of potential risk for the participants.
Amstelveenseweg 589
Amsterdam 1081JC
NL
Amstelveenseweg 589
Amsterdam 1081JC
NL
Listed location countries
Age
Inclusion criteria
severe depression conform DSM IV criteria egible for electroconvulsive therapy, inpatient, 60 years and older
Exclusion criteria
dementia, younger than 60 years
severe neurological disorder
incapacity to give informed consent
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 | NL31041.029.10 |