PMSPhase 4NCT00523705
Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study
A Phase 4 study testing escitalopram in people with PMS, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine the efficacy and safety of escitalopram administered premenstrually (day 14 through day 2 of the menstrual cycle) for severe PMS in young women ages 15-19 years. Read more about this study
- Who is it for?
- Ages 15 to 19 years, women only
- Conditions the study is for
- PMS
- What is being tested?
- escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Oct 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Females 15-19 years of age
- Regular menstrual cycles of 22-35 days
- In general good health
- Medically approved birth control method if sexually active
- Evidence of ovulation
- Meeting all symptom criteria for PMS
- Signed informed consent
- Subjects under age 18 must also have signed parental consent
Who cannot join
- Current use of any treatment for PMS.
- Psychotropic or other medications that may compromise the study drug.
- Pregnancy, intending pregnancy or breast feeding.
- Not using a medically approved birth control method if sexually active.
- Significant medical or gynecological abnormalities.
- Irregular menses, any gynecologic disorder.
Show all 16Show fewer
- Any severe or unstable medical illness.
- Any current major psychiatric diagnosis or any history of a major psychiatric diagnosis.
- Any current or history of alcohol abuse, drug abuse, suicide attempt, bi-polar disorder, psychosis or severe personality disorder.
- Use of triptans (Imitrex, Zomig, Frova, Maxalt, Axert, Amerge, Relpax).
- Use of medicines that include dextromethorphan such as Tylenol or Vicks cough medicines.
- Use of the pain medication meperidine.
- Use of any herbal product such as St John's Wort that may increase serotonin.
- Use of monoamine oxidase inhibitors (MAOIs), pimozide or citalopram hydrobromide.
- Drugs metabolized by CYP2D6 or a combination of CYP3A4 and CYP2D6 inhibitors.
- Hypersensitivity to escitalopram or citalopram.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dept OB/GYN, Mudd Professorship Suite
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this pilot study is to determine the efficacy and safety of escitalopram administered premenstrually (day 14 through day 2 of the menstrual cycle) for severe PMS in young women ages 15-19 years.
Read the detailed description
The medication in this study is a serotonin reuptake inhibitor (SSRI), a class that is considered the first-line treatment for severe PMS at this time. Although data indicate that young women who have PMS in their teen years report the same symptoms and symptom severity as adult women, clinical trials have not included this age group, and there is no information on the efficacy and safety of treatment with a serotonergic antidepressant for PMS in teens.
- Conditions
- PMS
- Being tested
- escitalopram, placebo
- Keywords
- premenstrual syndrome, PMS, PMDD, treatment, SSRI
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopramDrug
Also called Lexapro
10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
placeboOther
Placebo tablets matched to drug
| Study group | Role | What they receive |
|---|---|---|
| escitalopram | Experimental | Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects. Receives: Drug: escitalopram |
| placebo | Placebo comparator | Placebo tablets matched to drug. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Daily Symptom Rating Score.
A daily diary with 17 symptoms of PMS rated on a 5-point scale to indicate none to very severe symptoms. Minimum score 0; maximum score 408.
Measured: baseline and 5 months.
Secondary outcomes (3)
Sheehan Disability Scale (SDS)
Measured: Throughout study
Patient Global Evaluation of Improvement (PGE)
Measured: Throughout treatment
Subject Satisfaction Questionnaire
Measured: Study endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startFeb 2008
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: Enrollment too slow.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PMSStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
- Investigators
- Ellen Freeman, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523705
- Sponsor's protocol ID
- 805778
- Other IDs
- LXP-MD-123 (Forest Pharm), LXP-MD-123
- Status last verified
- Jun 2012
- First submitted
- 30 Aug 2007
- Last updated
- 6 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Vichnin M, Freeman EW, Lin H, Hillman J, Bui S. Premenstrual syndrome (PMS) in adolescents: severity and impairment. J Pediatr Adolesc Gynecol. 2006 Dec;19(6):397-402. doi: 10.1016/j.jpag.2006.06.015.
PubMed 17174829
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study
- ClinicalTrials.gov ID
- NCT00523705
- Acronym / sponsor ID
- 805778
- Conditions
- PMS
- Keywords
- premenstrual syndrome, PMS, PMDD, treatment, SSRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment too slow.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Feb 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 31 Aug 2007 (estimated)
- Results
- Posted 6 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to determine the efficacy and safety of escitalopram administered premenstrually (day 14 through day 2 of the menstrual cycle) for severe PMS in young women ages 15-19 years.
Detailed description
The medication in this study is a serotonin reuptake inhibitor (SSRI), a class that is considered the first-line treatment for severe PMS at this time. Although data indicate that young women who have PMS in their teen years report the same symptoms and symptom severity as adult women, clinical trials have not included this age group, and there is no information on the efficacy and safety of treatment with a serotonergic antidepressant for PMS in teens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| escitalopram | Experimental | Drug: escitalopramEscitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects. |
| placebo | Placebo comparator | Other: placeboPlacebo tablets matched to drug. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Females 15-19 years of age
- Regular menstrual cycles of 22-35 days
- In general good health
- Medically approved birth control method if sexually active
- Evidence of ovulation
Key exclusion criteria (16 listed)
- Current use of any treatment for PMS.
- Psychotropic or other medications that may compromise the study drug.
- Pregnancy, intending pregnancy or breast feeding.
- Not using a medically approved birth control method if sexually active.
- Significant medical or gynecological abnormalities.
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 |
|---|---|---|
| escitalopramAlso: Lexapro10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects. | Drug | escitalopram |
| placeboPlacebo tablets matched to drug | Other | placebo |
Primary outcome
Subject Daily Symptom Rating Score.
Time frame: baseline and 5 months.
A daily diary with 17 symptoms of PMS rated on a 5-point scale to indicate none to very severe symptoms. Minimum score 0; maximum score 408.
3 secondary outcomes
Sheehan Disability Scale (SDS)
Time frame: Throughout study
Patient Global Evaluation of Improvement (PGE)
Time frame: Throughout treatment
Subject Satisfaction Questionnaire
Time frame: Study endpoint
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17174829Vichnin M, Freeman EW, Lin H, Hillman J, Bui S. Premenstrual syndrome (PMS) in adolescents: severity and impairment. J Pediatr Adolesc Gynecol. 2006 Dec;19(6):397-402. doi: 10.1016/j.jpag.2006.06.015.
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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.
Ellen Freeman principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing escitalopram in people with PMS, run by University of Pennsylvania 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 8 inclusion and 16 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: stopped early, as of the sponsor's last update on 6 Jun 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Subject Daily Symptom Rating Score. (time frame: baseline and 5 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00523705, which also lists 1 linked publication.
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 6 Jun 2014.