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

NCT ID: NCT00370058

Last Updated: 2020-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2007-08-31

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.

Conditions

Depressive Disorder, Major

Keywords

ect; depression; homocysteine; mthfr genotype

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

ECT treatment

Intervention Type: PROCEDURE

Eligibility Criteria

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

Exclusion Criteria

• Major neurological or other diseases
• Current medication with antiepileptic drugs
• History of major head trauma
• Any medical condition not allowing anesthesia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Principal Investigators

Stefan Bleich, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Erlangen-Nuremberg

Wolfgang Sperling, M.D.

Role: STUDY_DIRECTOR

University of Erlangen-Nürnberg

Locations

Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg

Erlangen, , Germany

Countries

Germany

Other Identifiers

Homocystein

Identifier Type: -

Identifier Source: secondary_id

ECT

Identifier Type: -

Identifier Source: secondary_id

ECT and Homocysteine

Identifier Type: -

Identifier Source: org_study_id