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

Medical University of Vienna

Status and phase

Completed

Phase 4

Conditions

Unipolar Depression

Treatments

Procedure: ECT

Study type

Interventional

Funder types

Other

Identifiers

NCT00922064

MUW EC No. 556/2008

EKT-20090219 Version 1.3

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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