Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05837104
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2023-04-19
Brief Title:
Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder
Sponsor:
Mclean Hospital
Organization:
Mclean Hospital
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of Magnesium Vitamin B6 in Combination With Treatment as Usual in First Episode of Bipolar I Disorder
Status:
RECRUITING
Status Verified Date:
2024-03
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 is a randomized double-blind placebo-controlled proof-of-concept clinical trial to assess the efficacy and safety of Magnesium-vitamin B6in combination with treatment as usual for treating symptoms of depression stress and anxiety in patients with first episode bipolar I disorder
Detailed Description:
After a first episode of bipolar disorder subsequent depressive and anxiety symptoms can pose a major challenge to an individuals recovery early in the illness Individuals often have depressive and anxiety symptoms for a significant proportion of their time These mood and anxiety symptoms are associated with higher risk for relapse chronicity and disability Previous studies have shown that the combination of Magnesium-vitamin B6 has beneficial effects on stress and depressive and anxiety symptoms This randomized double-blind placebo-controlled trial will assess the benefits of Magnesium-vitamin B6 in combination with treatment as usual standard of clinical care on depressive and anxiety symptoms and stress in individuals with bipolar disorder in the early phase of illness In addition the investigators aim to assess the effects of Magnesium-vitamin B6 on brain free Mg2 and energy metabolism observed to be altered in bipolar disorder measured by in vivo 31P magnetic resonance spectroscopy 31P MRS Magnesium is a promising targeted intervention for bipolar disorder given its significant effects on energy metabolism
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None