Effects of ECT on Monoamine Oxidase A in Depression Investigated With PET

NCT02379767 | Completed DMC

• 1 other identifier: v1.2_201502
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at evaluating the effect of electroconvulsive therapy in treatment-resistant depressed patients on the major serotonin degrading enzyme in the human brain using neuroimaging methods, the monoamine oxidase A. Electroconvulsive therapy is an effective treatment option in severe cases of depression. However, the mechanisms underlying its effect remain uncertain, though variations within the serotonergic neurotransmitter system seem to be crucially involved.

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

• Monoamine oxidase A distribution volume in the brain

  MAOA DVs will be assessed using positron emission tomography

  5 weeks

Secondary Outcomes (1)

• Grey matter volume

  5 weeks

Study Arms (2)

Patients

Subjects aged between 18 and 60 years suffering from unipolar severe depression, who did not respond to conventional pharmacological antidepressant treatment (at least two adequate trials with antidepressants of different pharmacological classes over a minimum period of one month, equivalent to 150mg of tricyclic antidepressants). Concomitant psychotropic medication will be accepted during study participation, however, medication should remain stable throughout the study. Patients will undergo 6 to 14 ECT sessions in accordance with recent consensus statements and based on standard operation procedures (SOPs) of the Department of Psychiatry and Psychotherapy.

Device: Electroconvulsive therapy; Other: Positron emission tomography of the brain using [11C]harmine; Other: Structural magnetic resonance imaging

Healthy subjects

Subjects will be age- and sex-matched to the patients and should present no psychiatric, or major neurological or internistic illness.

Other: Positron emission tomography of the brain using [11C]harmine; Other: Structural magnetic resonance imaging

Interventions

Electroconvulsive therapy DEVICE

Patients

Positron emission tomography of the brain using [11C]harmine OTHER

Healthy subjects; Patients

Structural magnetic resonance imaging OTHER

Healthy subjects; Patients

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

18 patients with severe unipolar depression determined by a structured clinical interview for DSM-IV (SCID) and the 17-item Hamilton Rating Scale for Depression (HAM-D score ≥ 23) who did not respond to conventional pharmacological antidepressant treatment (at least two adequate trials with antidepressants of different pharmacological classes over a minimum period of one month, equivalent to 150mg of tricyclic antidepressants) will be recruited at the Department of Psychiatry and Psychotherapy at the General Hospital of Vienna. Additionally, 18 healthy age- and sex-matched controls will participate in this longitudinal study.

You may qualify if:

• Male or female
• Age 18 - 60 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/MRI days
• Anesthesiological approval for ECT
• Male or female
• Age 18 - 60 years
• Somatic health based on history, physical examination, ECG, and laboratory screening
• A maximum of 7 points on the 17-item HAM-D
• Signed informed consent form
• Negative urine pregnancy test in women at the screening visit and at PET/MRI days

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, including nicotine
• Current or past history of schizophrenia or schizoaffective disorder
• For participants who participated in an earlier neuroimaging study using ionizing radiation, the total radiation exposure dose of 20 mSv over the last 10 years must not be exceeded, as specified in the legislation on radiation protection (Allg. Strahlenschutzverordnung 2010; www.ris.bka.gv.at).
• Presence of any metallic implant contraindicated for MRI
• Previous treatments with electroconvulsive therapy
• Treatment (\< 1 months before screening) with bright light therapy
• Treatment (\< 1 months before screening) with drugs directly affecting the density and/or activity of monoamine oxidase A, e.g. moclobemid.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Psychiatry and Psychotherapy

Vienna, 1090, Austria

Location

Related Publications (1)

• Gryglewski G, Baldinger-Melich P, Seiger R, Godbersen GM, Michenthaler P, Klobl M, Spurny B, Kautzky A, Vanicek T, Kasper S, Frey R, Lanzenberger R. Structural changes in amygdala nuclei, hippocampal subfields and cortical thickness following electroconvulsive therapy in treatment-resistant depression: longitudinal analysis. Br J Psychiatry. 2019 Mar;214(3):159-167. doi: 10.1192/bjp.2018.224. Epub 2018 Nov 16.

  PMID: 30442205 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr. med.

Study Record Dates

• First Submitted: March 1, 2015
• First Posted: March 5, 2015
• Study Start: March 1, 2015
• Primary Completion: May 25, 2018
• Study Completion: May 25, 2018
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

AU (1)