nderstanding the Efficacy of Electroconvulsive Therapy in Patients with Unipolar and Bipolar Depressio
Completed
- Conditions
- DepressionDepressive Disorder10027946
- Registration Number
- NL-OMON40130
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 124
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)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the change in volume of hippocampal subdivisions.<br /><br>Vessel permeability, vessel size and density parameters will also be assessed .<br /><br>Changes in hippocampal blood vessel characteristics and volumes of hippocampal<br /><br>subdivisions are associated to clinical recovery from depression (changes in<br /><br>HAM-D score >50%).</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. A potential neurobiological basis for the cognitive side-effects of ECT will<br /><br>be assessed by screening all patients prior and after ECT for subtle tissue<br /><br>changes in grey and white matter brain structures and associating these to the<br /><br>severity of cognitive side-effects as measured by a battery of cognitive tests.<br /><br><br /><br>2. To compare pre- and posttreatment inflammatory, immunologic, genomic and<br /><br>proteomic markers in blood of patients treated with ECT and associate these to<br /><br>clinical recovery from depression.<br /><br><br /><br>3. To compare efficacy of ECT in patients with unipolar versus bipolar<br /><br>depression, as well as differences in values of vascularisation and volumes of<br /><br>subsections of the hippocampus.</p><br>