Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192725
Status:
COMPLETED
Last Update Posted:
2010-08-25
First Post:
2005-09-11
Brief Title:
Tryptophan Depletion in Acute Mania
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
Tryptophan Depletion in Acute Mania - A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2005-09
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:
Serotonin 5-HT is important in mood regulation and is believed to play a major role in the pathophysiology of major depression MD Selective serotonin reuptake inhibitors SSRIs are currently the most widely used drugs for the treatment of depression Patients with bipolar disorder BD who are treated for depression with SSRIs might develop mania which is believed to be triggered by antidepressant treatment Rapid tryptophan depletion RTD has been shown to induce transient depressive symptoms in remitted depressed patients treated with SSRIs In remitted manic patients treated with lithium RTD does not seem to have clinical effects However RTD was not studied in acutely manic patients and could theoretically have antimanic properties In this double blind randomized placebo controlled study RTD will be used as a tool to assess the role of 5-HT in mania and will be evaluated for its antimanic properties and potential use as augmentation to drug treatment in acute mania
Detailed Description:
None
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