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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rupert Lanzenberger, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00922064
First received: June 16, 2009
Last updated: November 15, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Unipolar Depression
Procedure: ECT
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of Electroconvulsive Therapy on Serotonin-1A Receptor Binding in Major Depression

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • serotonin-1A receptor binding potential [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: June 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ECT Procedure: ECT
ECT series consisting of 6 to 14 ECTs

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922064

Locations
Austria
Medical University of Vienna, Dept. of Psychiatry and Psychotherapy
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Richard Frey, MD Medical University of Vienna, Dept. of Psychiatry and Psychotherapy
  More Information

No publications provided

Responsible Party: Rupert Lanzenberger, A/Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00922064     History of Changes
Other Study ID Numbers: EKT-20090219 Version 1.3, MUW EC No. 556/2008
Study First Received: June 16, 2009
Last Updated: November 15, 2011
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014