This study aims to investigate the neurobiological basis underlying the strong antidepressant effect of ECT in patients with unipolar and bipolar depression using MRI. We will also assess a potential neurobiological basis for the cognitive side-…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the change in volume of hippocampal subdivisions.
Vessel permeability, vessel size and density parameters will also be assessed .
Changes in hippocampal blood vessel characteristics and volumes of hippocampal
subdivisions are associated to clinical recovery from depression (changes in
HAM-D score >50%).
Secondary outcome
1. A potential neurobiological basis for the cognitive side-effects of ECT will
be assessed by screening all patients prior and after ECT for subtle tissue
changes in grey and white matter brain structures and associating these to the
severity of cognitive side-effects as measured by a battery of cognitive tests.
2. To compare pre- and posttreatment inflammatory, immunologic, genomic and
proteomic markers in blood of patients treated with ECT and associate these to
clinical recovery from depression.
3. To compare efficacy of ECT in patients with unipolar versus bipolar
depression, as well as differences in values of vascularisation and volumes of
subsections of the hippocampus.
Background summary
Electroconvulsive therapy (ECT) is the oldest and most effective therapy in
major depressive disorder (MDD). However, its mechanism of action is still
unresolved. Recent evidence suggests that the efficacy of pharmacotherapy and
psychotherapy in MDD has been overstated with effect sizes considerably lower
than previously claimed (0.3) while ECT has an estimated effect size of 1.0.
Nevertheless, ECT carries all the risks of general anaesthesia and is
associated with (severe) cognitive impairment. Therefore, understanding the
mechanism of action of ECT is a necessary step in the development of new safer
treatment methods for MDD. Animal studies showed that ECT induces angiogenesis
and neurogenesis in the dentate gyrus of the hippocampus. It is currently
unclear if these findings can be translated to patients with MDD. By
investigating the structural changes in the hippocampus of patients with
unipolar and bipolar depression treated with 10 ECT sessions we intend to
elucidate the working mechanism of ECT.
Study objective
This study aims to investigate the neurobiological basis underlying the strong
antidepressant effect of ECT in patients with unipolar and bipolar depression
using MRI. We will also assess a potential neurobiological basis for the
cognitive side-effects of ECT, assess the immunologic and inflammatory
parameters in patients pre- and post-ECT, and collect data on genomics. We will
try to correlate these to clinical recovery and cognitive side-effects.
Moreover, efficacy of ECT in patients with unipolar versus bipolar depression
is compared.
Study design
The objectives are tested in a controlled observational trial using MRI
scanning, blood samples for inflammatory and immunologic assessment and
proteome based biomarkers and genomics, and cognitive testing to assess
cognitive side-effects.
Study burden and risks
Additional to the risks generally associated with ECT (such as cognitive
impairment and risks associated with general anaesthesia) which are not due to
participation, there are only minor risks. Lying in the MRI scanner (estimated
time maximum of 50 minutes) may trigger claustrophobia and discomfort in some
participants. Participants are accompanied by an experienved researcher or
research nurse. To make the procedure as comfortable as possible, participants
are provided with pillows and earplugs or headphones (to listen to music).
Contrast is not used, and subjects are not asked to perform any tasks. Vene
puncture may cause haematoma or infection. Cognitive testing (1.5 hour) may
require sustained attention of the participant. The burden consists of 4 hours
at t1 (M.I.N.I.-plus, HAM-D, MRI-scan, cognitive assessment, blood), 3 hours at
t2 (HAM-D, MRI-scan, cognitive assessment, blood), and 2 hours at t3 (6 months
follow-up: HAM-D and cognitive assessment). Burden for healthy controls will be
4 hours at visit 1 (M.I.N.I.-plus, MRI-scan, blood, cognitive assessment) and
2.5 hours at visit 2 (cognitive assessment and MRI-scan).
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
Patients only:
- Diagnosis of depressive disorder according to the DSM-IV-TR criteria, either unipolar or bipolar
- Indication for electroconvulsive therapy;All subjects:
- Written informed consent
- Age 18 years and older
Exclusion criteria
All subjects:
- Severe cognitive impairments (Alzheimer's disease, vascular dementia)
- Pregnancy and/or lactation
- Not legally capable / not of sound mind and judgement;Patients only:
- ECT in the past 6 months;Controls only:
- Any psychiatric illness (according to the M.I.N.I.-plus interview)
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 | NL43935.041.13 |