Viewing Study NCT00516113



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Last Modification Date: 2024-10-26 @ 9:35 AM
Study NCT ID: NCT00516113
Status: COMPLETED
Last Update Posted: 2007-12-07
First Post: 2007-08-13

Brief Title: A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine in Premenstrual Dysphoria
Sponsor: Karolinska Institutet
Organization: Karolinska Institutet

Study Overview

Official Title: A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine When Used for the Treatment of Premenstrual Dysphoria
Status: COMPLETED
Status Verified Date: 2007-08
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: The objective of this study is to explore the onset of action when serotonin reuptake inhibitors are used to treat premenstrual dysphoric disorder
Detailed Description: Whereas serotonin reuptake inhibitors SRIs usually require weeks of treatment to effectively counteract depressed mood or anxiety several studies suggest that they may reduce the symptoms irritability and anger more rapidly In line with this SRIs have been shown to reduce certain symptoms including irritability in women with premenstrual dysphoric disorder PMDD when the drug only is administered from ovulation to menstruation only which indicates an onset of action of 10 days or less How fast this effect appears in terms of hours or days is however not known The objective of this study was to explore this issue

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