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Study on the Influence of Electroconvulsive Therapy (ECT) on Homocysteine Levels

Primary Purpose

Depressive Disorder, Major

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

ECT treatment

About this trial

This is an interventional diagnostic trial for Depressive Disorder, Major focused on measuring ect, depression, homocysteine, mthfr genotype

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: Men and women aged 18 years or above Diagnosis of major depressive disorder (according to DSM IV) Secured therapy resistance (at least two trials with antidepressive medication of different classes for more then 4 weeks in adequate dosage) Written, informed consent Key Exclusion Criteria: Major neurological or other diseases Current medication with antiepileptic drugs History of major head trauma Any medical condition not allowing anesthesia

Sites / Locations

Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg

Outcomes

Primary Outcome Measures

Homocysteine serum levels

Secondary Outcome Measures

Cognitive functioning (e.g. concentration, memory tasks, etc.)

Depressive symptomatology

Measures of Seizure quality (duration, threshold, postictal suppression index, ...)

Full Information

NCT ID

NCT00370058

First Posted

August 29, 2006

Last Updated

December 10, 2020

Sponsor

University of Erlangen-Nürnberg Medical School

1. Study Identification

Unique Protocol Identification Number

NCT00370058

Brief Title

Study on the Influence of Electroconvulsive Therapy (ECT) on Homocysteine Levels

Official Title

Modulation of Homocysteine-Plasma Levels by ECT - Association With Clinical Response. A Pilot Study in Patients With Major Depression

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Erlangen-Nürnberg Medical School

4. Oversight

5. Study Description

Brief Summary

Elevated homocysteine levels are associated with depression and cognitive impairment. When depression ameliorates due to treatment, homocysteine serum levels often normalize. Aim of the present study is to investigate, whether repeated ECT treatment leads to changes in homocysteine levels and if these changes are associated with the occurrence of cognitive impairment after ECS. 10 patients suffering from therapy-resistant depression shall be enrolled. Patients are treated with repeated ECT (three times the week). Before, directly after and one day after ECT treatment, blood samples are drawn and patients receive cognitive testing. Depressive symptomatology is checked with different rating scales.

Detailed Description

BACKGROUND: Elevated homocysteine levels have been found in depressive disorders. The modulating effects of homocysteine on glutamatergic neurotransmission have been discussed to be an underlying cause of depression and can also lead to cognitive impairment and may facilitate seizures. Electroconvulsive therapy is the most effective treatment for depression, but often leads to cognitive impairments. HYPOTHESIS: Homocysteine levels normalize during rECT. This normalization is associated with the clinical improvement of depression. Short term changes in homocysteine levels (i.e. increase directly after ECT) may explain the cognitive impairments of the patients. METHOD: 10 patients with therapy-resistant depressive disorder are to be enrolled into the trial. Patients are treated with rECT, two to three times a week. Blood withdrawal and psychometric analysis will be performed before, directly after and one day after ECT treatment 1,4,7,10,(13). Necessity of further treatment will be checked after the first 6 ECTs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder, Major

Keywords

ect, depression, homocysteine, mthfr genotype

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

ECT treatment

Primary Outcome Measure Information:

Title

Homocysteine serum levels

Secondary Outcome Measure Information:

Title

Cognitive functioning (e.g. concentration, memory tasks, etc.)

Title

Depressive symptomatology

Title

Measures of Seizure quality (duration, threshold, postictal suppression index, ...)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stefan Bleich, M.D.

Organizational Affiliation

University Erlangen-Nuremberg

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Wolfgang Sperling, M.D.

Organizational Affiliation

University of Erlangen-Nürnberg

Official's Role

Study Director

Facility Information:

Facility Name

Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

12. IPD Sharing Statement

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Study on the Influence of Electroconvulsive Therapy (ECT) on Homocysteine Levels

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