Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
This study has been completed.
Sponsor:
Yale University
Collaborator:
Information provided by (Responsible Party):
Kimberly Yonkers, Yale University
ClinicalTrials.gov Identifier:
NCT00048854
First received: November 8, 2002
Last updated: August 7, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Premenstrual Syndrome |
Drug: Sertraline Other: Treatment as usual (TAU) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder |
Resource links provided by NLM:
Further study details as provided by Yale University:
Primary Outcome Measures:
- Premenstrual Tension Scale (PMTS) [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Inventory of Depressive Symptomatology Clinician-rated version (IDS-C) [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]
- Patient Global Impressions scale [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]
- Quality of Life, Enjoyment, and Satisfaction Questionnaire Scale (Q-LES-Q) [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]
| Enrollment: | 66 |
| Study Start Date: | September 2001 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Participants will receive treatment as usual
|
Other: Treatment as usual (TAU)
At the TAU baseline visit, patients will be told of their diagnosis of PMS/PMDD. Those patients who decide to seek treatment outside of the study protocol or do not wish to seek treatment will be asked to participate in the TAU part of this protocol. Patients in TAU will be contacted monthly to obtain monthly information about how they have been feeling (blinded ratings) using the study measures.
Other Name: TAU
|
|
Experimental: 2
Participants will take sertraline
|
Drug: Sertraline
Patients who meet study criteria will be given 50 mg per day of sertraline to be taken an estimated 2 weeks before menstruation.
Other Name: Zoloft
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 48 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- DSM-IV criteria for Premenstrual syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD)
- For a diagnosis of PMS but not PMDD, patients must have 3 to 4 symptoms, complain of functional impairment as a result of their symptoms, and identify symptoms as problematic enough to warrant treatment
- Symptoms of PMS/PMDD in at least 9 of 12 menstrual cycles during the year prior to screening
- Symptom-free during the follicular phase and impairment during the luteal phase
- Regular menstrual cycles
- Adequate methods of birth control
Exclusion Criteria:
- Major depression, bipolar disorder, or psychotic disorders
- Hepatitis or hepatic failure
- Amenorrhea, oligomenorrhea, blood dyscrasias, or illnesses for which monoamine oxidase inhibitors must be prescribed
- Follicular phase symptoms consistent with a diagnosis of major depression, bipolar disorder, or psychotic disorders
- Co-existing condition that renders the patient unsuitable for the study
- Risk of suicide
- Antidepressants or other psychotropic medication
- Hypersensitivity or adverse reaction to sertraline
- Pregnancy, breast-feeding, or plans to become pregnant during the course of the study
- Depot hormonal preparation or any other medication that would lead to lack of menses or markedly irregular menses
Contacts and Locations More Information
No publications provided
| Responsible Party: | Kimberly Yonkers, Professor, Yale University |
| ClinicalTrials.gov Identifier: | NCT00048854 History of Changes |
| Other Study ID Numbers: | R21 MH62379, R21MH062379, DSIR AT-SO |
| Study First Received: | November 8, 2002 |
| Last Updated: | August 7, 2012 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Premenstrual Syndrome Menstruation Disturbances Pathologic Processes Antidepressive Agents Sertraline Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013