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

NCT00922064 | Completed Phase 4 DMC

• 2 other identifiers: EKT-20090219 Version 1.3MUW EC No. 556/2008
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unipolar Depression

Outcome Measures

Primary Outcomes (1)

• serotonin-1A receptor binding potential

  2 months

Study Arms (1)

ECT

EXPERIMENTAL

Procedure: ECT

Interventions

ECT PROCEDURE

ECT series consisting of 6 to 14 ECTs

ECT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Anesthesiological approval for ECT

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Dept. of Psychiatry and Psychotherapy

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Richard Frey, MD

  Medical University of Vienna, Dept. of Psychiatry and Psychotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A/Prof. PD Dr.

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 17, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 16, 2011

Record last verified: 2011-11

Locations

AU (1)