Ignite Creation Date:
2024-05-05 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 9:48 AM
Study NCT ID:
NCT00664976
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2008-04-14
Brief Title:
Treatment Resistant Depression in Bipolar Disorder - A Randomized Controlled Trial of Electroconvulsive Therapy
Sponsor:
Norwegian University of Science and Technology
Organization:
Norwegian University of Science and Technology
Study Overview
Official Title:
Treatment Resistant Depression in Bipolar Disorder - A Randomized Controlled Trial of Electroconvulsive Therapy
Status:
COMPLETED
Status Verified Date:
2017-01
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:
This project is a randomized controlled trial of electroconvulsive therapy ECT compared to treatment as usual TAU in the treatment of treatment resistant depression TRD in bipolar disorder The purpose of the trial is to document the effect size relative effect size and adverse effects of ECT in this condition A specific purpose is to gain more knowledge about the effect on cognitive function
Detailed Description:
This project is a randomized controlled trial of electroconvulsive therapy ECT compared to treatment as usual TAU in the treatment of treatment resistant depression TRD in bipolar disorder The purpose of the trial is to document the effect size relative effect size and adverse effects of ECT in this condition A specific purpose is to gain more knowledge about the effect on cognitive function
In a national collaboration project the investigators will compare the antidepressant and cognitive effects of ECT with the effects of a drug treatment in use for this condition a treatment algorithm combining antidepressants mood stabilizer and antipsychotic drugs The investigators will use a neuropsychological test battery to disclose possible ECT induced changes in cognitive function and investigate any long-lasting changes
In addition several studies have implemented inflammatory processes in the pathogenesis of depression inflammatory processes will be examined as a function of changes in clinical status and of treatment modality
The study is a national collaboration using the Bipolar Research And Innovation Network- BRAIN and all the patients are included in the BRAIN-study The study is funded by Helse Vest RHF Regional research network on mood disorders MoodNet and Norwegian hospitals
In a national collaboration project the investigators will compare the antidepressant and cognitive effects of ECT with the effects of a drug treatment in use for this condition a treatment algorithm combining antidepressants mood stabilizer and antipsychotic drugs The investigators will use a neuropsychological test battery to disclose possible ECT induced changes in cognitive function and investigate any long-lasting changes
In addition several studies have implemented inflammatory processes in the pathogenesis of depression inflammatory processes will be examined as a function of changes in clinical status and of treatment modality
The study is a national collaboration using the Bipolar Research And Innovation Network- BRAIN and all the patients are included in the BRAIN-study The study is funded by Helse Vest RHF Regional research network on mood disorders MoodNet and Norwegian hospitals
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