Neurobiological Changes When Treating Depression With Electroconvulsive Therapy - a Longitudinal Observational Study

Depression Clinical Trial

Official title:

Neurobiological Changes and Clinical Outcome When Treating Depression With Electroconvulsive Therapy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01869868
• Other study ID #: LIU2012/310-31
• Secondary ID: LinkoepingUniver
• Status: Recruiting
• Phase: N/A
• First received: June 2, 2013
• Last updated: April 28, 2015
• Start date: December 2013

Study information

• Verified date: April 2015
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to determine functional and structural changes in brain following treatment of severe depression with electroconvulsive therapy with correlation to clinical outcome. Our hypothesis is that there are state-dependent changes in functional connectivity within specific neurocircuits systems, as well as structural plasticity changes in hippocampus, when recovering from depression.

Description:

The study is a prospective, within-subject, observational follow-up study in individuals with depression who receive electroconvulsive therapy (ECT)at a psychiatric clinic. We will use a consecutive sampling method and patient referred for ECT by their psychiatrist will be screened for inclusion and asked for participation. Both in - and outpatients can be included. At three occasions (before treatment, after four week and after three months) patients will be assessed with clinical ratings, cognitive tests, functional and structural magnetic resonance imaging and biomarkers for cell proliferation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• major depressive disorder

• depressive episode in bipolar disorder

• age 18 - 65 years

Exclusion Criteria:

• alcohol- and/or drug dependence or abuse in the past 3 months

• severe/life-threatening medical disease

• pregnancy

• type I diabetes

• neurodegenerative disorder

• inability to give written informed consent to participation in the study

• contradiction to MRI scanning.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Locations

Country	Name	City	State
Sweden	Linkoeping University, Linkoeping University Hospital	Linkoeping	Ostergotland

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measures of hippocampal volume assessed by structural MRI		Three months	No
Primary	fMRI BOLD resting state functional connectivity		3 month	No
Primary	fMRI BOLD responses during execution of emotional and reward processing tasks		3 months	No
Primary	Biomarkers of cell proliferation		3 months	No
Secondary	Relation between neurobiological changes and clinical and cognitive outcome		Three months	No