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

Depressive Disorder, Major Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370058
• Other study ID #: ECT and Homocysteine
• Secondary ID: HomocysteinECT
• Status: Completed
• Phase: Phase 4
• Start date: August 2006
• Est. completion date: August 2007

Study information

• Verified date: December 2020
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major

Intervention

Procedure:
• ECT treatment

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Homocysteine serum levels
Secondary	Cognitive functioning (e.g. concentration, memory tasks, etc.)
Secondary	Depressive symptomatology
Secondary	Measures of Seizure quality (duration, threshold, postictal suppression index, ...)