Understanding the Efficacy of Electroconvulsive Therapy in Patients with Unipolar and Bipolar Depression

Understanding the Efficacy of Electroconvulsive Therapy in Patients with Unipolar and Bipolar Depression - The Efficacy of ECT in Patients with Depression

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40130

Enrollment

124

Registered

2013-09-03

Start date

2014-03-12

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Depression Depressive Disorder

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results