Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048854
Status:
COMPLETED
Last Update Posted:
2016-01-12
First Post:
2002-11-08
Brief Title:
Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
Status:
COMPLETED
Status Verified Date:
2016-01
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 study will determine whether characteristics of women with Premenstrual Syndrome influence response to treatment with serotonin reuptake inhibitors and whether SRIs can alleviate premenstrual symptoms
Detailed Description:
Moderate to severe premenstrual disturbances afflict up to 20 percent of women Studies have shown the use of serotonin reuptake inhibitors SRIs during the luteal phase of the menstrual cycle to be effective in improving symptoms in women with premenstrual dysphoric disorder PMDD Unfortunately SRI treatment has only been evaluated in controlled clinical trials and evidence suggests that patients in these clinical trials are not representative of women commonly seen in clinical practice Thus the real-world feasibility of intermittent dosing is questionable
Patients in this study receive sertraline Zoloft during the luteal phase of their menstrual cycle every month for 6 months The dose may be modified based on structured interviews with the patients Assessments include questionnaires and interviews which take place at study start at midpoint and at the end of the study
Patients in this study receive sertraline Zoloft during the luteal phase of their menstrual cycle every month for 6 months The dose may be modified based on structured interviews with the patients Assessments include questionnaires and interviews which take place at study start at midpoint and at the end of the study
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 |
|---|---|---|---|
| DSIR AT-SO | US NIH GrantContract | None | httpsreporternihgovquickSearchR21MH062379 |
| R21MH062379 | NIH | None | None |