Premenstrual SyndromePhase 1/2NCT00048854
Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
A Phase 1/2 study testing Sertraline and Treatment as usual (TAU) in people with Premenstrual Syndrome, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Sertraline and Treatment as usual (TAU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Jan 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06510
About this study
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.
Read the 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.
- Conditions
- Premenstrual Syndrome
- Being tested
- Sertraline, Treatment as usual (TAU)
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called Zoloft
Patients who meet study criteria will be given 50 mg per day of sertraline to be taken an estimated 2 weeks before menstruation.
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants will receive treatment as usual Receives: Other: Treatment as usual (TAU) |
| 2 | Experimental | Participants will take sertraline Receives: Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual Tension Scale (PMTS)
Measured: Measured at Month 8
Secondary outcomes (3)
Inventory of Depressive Symptomatology Clinician-rated version (IDS-C)
Measured: Measured at Month 8
Patient Global Impressions scale
Measured: Measured at Month 8
Quality of Life, Enjoyment, and Satisfaction Questionnaire Scale (Q-LES-Q)
Measured: Measured at Month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2002 (estimated)
- Study startSep 2001
- Primary completionJun 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Kimberly A Yonkers, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048854
- Sponsor's protocol ID
- 0108012595
- Other IDs
- R21MH062379, DSIR AT-SO
- Status last verified
- Jan 2016
- First submitted
- 8 Nov 2002
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
- ClinicalTrials.gov ID
- NCT00048854
- Acronym / sponsor ID
- 0108012595
- Conditions
- Premenstrual Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2001
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 13 Nov 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Treatment as usual (TAU)Participants will receive treatment as usual |
| 2 | Experimental | Drug: SertralineParticipants will take sertraline |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SertralineAlso: ZoloftPatients who meet study criteria will be given 50 mg per day of sertraline to be taken an estimated 2 weeks before menstruation. | Drug | 2 |
| Treatment as usual (TAU)Also: TAUAt 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 | 1 |
Primary outcome
Premenstrual Tension Scale (PMTS)
Time frame: Measured at Month 8
3 secondary outcomes
Inventory of Depressive Symptomatology Clinician-rated version (IDS-C)
Time frame: Measured at Month 8
Patient Global Impressions scale
Time frame: Measured at Month 8
Quality of Life, Enjoyment, and Satisfaction Questionnaire Scale (Q-LES-Q)
Time frame: Measured at Month 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly A Yonkers, MD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sertraline and Treatment as usual (TAU) in people with Premenstrual Syndrome, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premenstrual Tension Scale (PMTS) (time frame: Measured at Month 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.