Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370058
Status:
COMPLETED
Last Update Posted:
2020-12-14
First Post:
2006-08-29
Brief Title:
Study on the Influence of Electroconvulsive Therapy ECT on Homocysteine Levels
Sponsor:
University of Erlangen-Nürnberg Medical School
Organization:
University of Erlangen-Nürnberg Medical School
Study Overview
Official Title:
Modulation of Homocysteine-Plasma Levels by ECT - Association With Clinical Response A Pilot Study in Patients With Major Depression
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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 1471013 Necessity of further treatment will be checked after the first 6 ECTs
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 ie 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 1471013 Necessity of further treatment will be checked after the first 6 ECTs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ECT | None | None | None |
| Homocystein | None | None | None |