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

Neuroimaging, Neuropsychological, Quality of life effects and costs of Deep Brain Stimulation in Treatment-refractory patients with Major Depressive Disorder - Neuroimaging, NPI, QOL effects and costs of DBS in TRD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36601

Enrollment

126

Registered

2009-11-26

Start date

2010-03-12

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

treatment resistant depression untreatable depression

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Neuroimaging: Changes in D2 receptor binding Neuropsychological: Changes in cognitive functioning Quality of life and economic evaluation: Changes in Quality of life Amendement: Changes in D2 receptor binding	—

Secondary

Measure	Time frame
Neuroimaging: Changes in cerebral perfusion Neuropsychological: - Quality of life and economic evaluation Changes in resource utilisation and costs involved Amendement: -	—

Countries

Netherlands

Outcome results