Effects of Electroconvulsive Therapy (ECT) on Serotonin-1A Receptor Binding

In treatment-resistant depression, electroconvulsive therapy (ECT) has been shown to effectively reduce depressive symptoms, though the underlying neurobiological mechanism is still unclear. The serotonergic system, and in particular the inhibitory serotonin-1A (5-HT1A) receptor, appears to be significantly involved in the effectiveness of ECT. The aim of the study is to assess the effects of ECT on the 5-HT1A receptor binding potential (BPND) and distribution in humans in vivo using positron emission tomography (PET) and the radioligand [carbonyl-11C]WAY-100635.

12 patients suffering from severe, therapy-resistant unipolar depression will undergo 3 PET scans, two of these scans taking place before the ECT treatment, consisting of 6-14 ECTs, the third scan taking place after the ECT treatment.

This imaging study hypothesizes that upon completion of the ECT, the overall 5-HT1A receptor BPND in the brain of depressed patients will significantly change.

This study would be the first to demonstrate an effect of electroconvulsive therapy on the 5-HT1A receptor binding in humans in vivo. Given the involvement of the 5-HT1A receptor in the pathophysiology of mood disorders, the present study would be an important step towards a better understanding of antidepressant treatment and treatment response. By comparing treatment effect and the underlying biological mechanism, the study might help to identify biomarkers that distinguish patients who are likely to benefit from ECT from patients who will rather be non-responders. Finally, by investigating the role of the 5-HT1A receptor in ECT, is highly discussed relevance for antidepressant action will be further elucidated and might prepare the ground for new therapeutic strategies.

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Key information

Conditions

Unipolar Depression Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Vienna, Dept. of Psychiatry and Psychotherapy

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female
Age 18 - 65 years
ICD-10 diagnosis of severe unipolar depression (ICD-10: F32.2, F32.3; F33.2, F33.3)
A score of 23 or greater on the 17-item HAM-D
Signed informed consent form
Negative urine pregnancy test in women at the screening visit and at PET days
Antidepressive and antipsychotic medication in a steady state for at least 10 days prior to inclusion
Anesthesiological approval for ECT

Exclusion criteria

Concomitant major internistic or neurological illness
Clinically relevant abnormalities on a general physical examination and routine laboratory screening
Current substance abuse, addiction
Current or past history of schizophrenia or schizoaffective disorder
Exposure to artificial radiation as volunteer in clinical studies within 10 years prior to inclusion into the present study
Previous treatments with electroconvulsive therapy
Treatment (< 1 months before screening) with the following drugs: Aripiprazole, Risperidone, Ziprasidone, Clozapine, Chlorpromazine, Amitryptyline, Nefazodone, Trazodone, Buspirone, Pindolol, Penbutolol, Tertatolol, Alprenolol, Quetiapine
Investigations using PET or SPECT within 10 years prior to the inclusion

Treatment and study plan

ECT

Procedure

ECT series consisting of 6 to 14 ECTs

Primary outcomes

serotonin-1A receptor binding potential

Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Effects of Electroconvulsive Therapy on Serotonin-1A Receptor Binding in Major Depression

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Jun 17, 2009
Registry last updated: Nov 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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