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Clinical Trials/NCT01869868
NCT01869868
Unknown
N/A

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

Linkoeping University1 site in 1 country50 target enrollmentDecember 2013
ConditionsDepression

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression
Sponsor
Linkoeping University
Enrollment
50
Locations
1
Primary Endpoint
Measures of hippocampal volume assessed by structural MRI
Last Updated
11 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
December 2015
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Linkoeping University
Responsible Party
Principal Investigator
Principal Investigator

Pia Nordanskog

MD

Linkoeping University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Measures of hippocampal volume assessed by structural MRI

Time Frame: Three months

fMRI BOLD resting state functional connectivity

Time Frame: 3 month

fMRI BOLD responses during execution of emotional and reward processing tasks

Time Frame: 3 months

Biomarkers of cell proliferation

Time Frame: 3 months

Secondary Outcomes

  • Relation between neurobiological changes and clinical and cognitive outcome(Three months)

Study Sites (1)

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