euroimaging, Neuropsychological, Quality of life effects and costs of Deep Brain Stimulation in Treatment-refractory patients with Major Depressive Disorder

Completed

• Conditions: treatment resistant depression; untreatable depression; 10027946

• Registration Number: NL-OMON36601
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 126

Inclusion Criteria

* Primary diagnosis: Major Depressive Disorder (MDD)
* HAM-D total score: equal or above 18
* Disabling severity with substantial functional impairment
* Treatment refractoriness

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: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Neuroimaging:<br /><br>Changes in D2 receptor binding<br /><br><br /><br>Neuropsychological:<br /><br>Changes in cognitive functioning<br /><br><br /><br>Quality of life and economic evaluation:<br /><br>Changes in Quality of life<br /><br><br /><br>Amendement:<br /><br>Changes in D2 receptor binding</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Neuroimaging:<br /><br>Changes in cerebral perfusion<br /><br><br /><br>Neuropsychological:<br /><br>-<br /><br><br /><br>Quality of life and economic evaluation<br /><br>Changes in resource utilisation and costs involved<br /><br><br /><br>Amendement:<br /><br>-</p><br>