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
Verified date | December 2020 |
Source | University of Erlangen-Nürnberg Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg | Erlangen |
Lead Sponsor | Collaborator |
---|---|
University of Erlangen-Nürnberg Medical School |
Germany,
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, ...) |
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