NCT00048854

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2001

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2002

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2002

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

5.8 years

First QC Date

November 8, 2002

Last Update Submit

January 11, 2016

Conditions

Premenstrual Syndrome

Outcome Measures

Primary Outcomes (1)

  • Premenstrual Tension Scale (PMTS)

    Measured at Month 8

Secondary Outcomes (3)

  • Inventory of Depressive Symptomatology Clinician-rated version (IDS-C)

    Measured at Month 8

  • Patient Global Impressions scale

    Measured at Month 8

  • Quality of Life, Enjoyment, and Satisfaction Questionnaire Scale (Q-LES-Q)

    Measured at Month 8

Study Arms (2)

1

ACTIVE COMPARATOR

Participants will receive treatment as usual

Other: Treatment as usual (TAU)

2

EXPERIMENTAL

Participants will take sertraline

Drug: Sertraline

Interventions

SertralineDRUG

Patients who meet study criteria will be given 50 mg per day of sertraline to be taken an estimated 2 weeks before menstruation.

Also known as: Zoloft
2
Treatment as usual (TAU)OTHER

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.

Also known as: TAU
1

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

SertralineTherapeutics

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Kimberly A Yonkers, MD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2002

First Posted

November 13, 2002

Study Start

September 1, 2001

Primary Completion

June 1, 2007

Study Completion

January 1, 2008

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

US(1)