Premenstrual Dysphoric DisorderPhase 4NCT00678574
The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder
A Phase 4 study testing fluoxetine in people with Premenstrual Dysphoric Disorder and Premenstrual Syndrome, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of the study proposed is to investigate the role of neurosteroids and GABA in the pathophysiology and treatment of premenstrual dysphoric disorder (PMDD) by 1) measuring cortical gama-aminobutyric acid levels (GABA levels) using nuclear magnetic resonance spectroscopy (MRS) during the follicular and… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Dysphoric Disorder, Premenstrual Syndrome
- What is being tested?
- fluoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1998to Dec 2008
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 - 45 years old and able to give voluntary written informed consent.
- Willing to complete a daily log of mood symptoms for 7 consecutive menstrual cycles: two menstrual cycles during the Screening Phase (Phase 1), one menstrual cycle during the Testing Phase (Phase 2), and four menstrual cycles during the Medication Treatment Phase and Post-Treatment Phase (Phase 3). All subjects who successfully complete Phases 1 and 2, and the Medication Treatment Phase, will be invited to participate in Phase 3 approximately three months later. Phase 3 will involve repeating all procedures conducted in Phase 2, including the daily log of mood symptoms.
- Meet DSM-IV criteria for premenstrual dysphoric disorder, confirmed by the Daily Record of Severity of Problems (DRSP; Endicott \& Harrison) for 2 consecutive menstrual cycles (Phase 1). The DRSP is a self-rated symptom checklist, which requires individuals to rate their symptoms of PMDD according to the DSM-IV research criteria scale on a scale from 1 (symptom not present) to 6 (symptom extreme). During the last 7 days of the menstrual cycle compared to days 5-11, patients must have a 30% increase in their average (over 2 menstrual cycles) score for 5 of these 10 symptoms. Symptoms must be "not present" or "minimal" during the postmenstrual week.
- Average 19-item Hamilton Depression Rating Scale (HAM-D) scores < 5 during the follicular phase and > 16 during the luteal phase.
- Have regular menstrual cycles 28 to 32 days in length. Each of the screening cycles must be ovulatory as confirmed by plasma progesterone levels of >5 ng/ml during the luteal phase.
Who cannot join
- Presence of any other comorbid DSM-IV Axis I disorder.
- Meeting DSM-IV criteria for psychoactive substance (excluding nicotine) dependence within the preceding 4 months.
- A history of serious medical or neurological illness, including (but not limited to) major cardiovascular disease, severe hypertension, intracranial mass lesions, seizure disorder, severe hepatic or renal disease, unstable endocrine or metabolic disease, and unstable hematologic disease.
- Use of anticonvulsant or benzodiazepines within the last month.
- Use of psychotropic medication in last week (except as stated above).
- Use of steroid contraceptives within the previous 4 months, including birth control pill, birth control patch, birth control ring, and Depo-Provera®. Subjects will be asked to use abstinence or the barrier method (condoms) as forms of contraception in this study.
Show all 9Show fewer
- Alcohol consumption greater than 7 drinks/week.
- Current pregnancy.
- Metallic implants.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study proposed is to investigate the role of neurosteroids and GABA in the pathophysiology and treatment of premenstrual dysphoric disorder (PMDD) by 1) measuring cortical gama-aminobutyric acid levels (GABA levels) using nuclear magnetic resonance spectroscopy (MRS) during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the selective serotonin reuptake inhibitor (SSRI) fluoxetine (Prozac®, Sarafem®), and 2) correlating cerebrospinal fluid (CSF) and plasma GABA and neurosteroid levels with cortical GABA levels at these same time points. Neurosteroids to be measured include allopregnanolone, pregnenolone, and pregnenolone sulfate. Findings from women with PMDD will be compared to those of healthy subjects.
- Being tested
- fluoxetine
- Keywords
- hormones, menses, PMS, PMDD
- Medical subject headings
- Premenstrual Dysphoric Disorder, Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluoxetineDrug
Also called Prozac, Sarafem
Fluoxetine 20 mg daily by mouth for 2-3 months.
| Study group | Role | What they receive |
|---|---|---|
| Premenstrual Dysphoric Disorder (PMDD) group | Experimental | PMDD group received fluoxetine 20 mg daily by mouth for 2-3 months Receives: Drug: fluoxetine |
| Healthy controls | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cortical Gama-aminobutyric Acid Levels (GABA Levels) Pre and Post SSRI Treatment
GABA levels would be assessed during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the SSRI.
Measured: 2-3 months post-treatment w/ fluoxetine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startMar 1998
- Primary completionDec 2008
- Study completionDec 2008
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.
- Other trials for Premenstrual Dysphoric DisorderStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Cynthia N Epperson, MD, Principal investigator, University of Pennsylvania School of Medicine Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678574
- Sponsor's protocol ID
- 9803010098
- Status last verified
- Jul 2017
- First submitted
- 13 May 2008
- Last updated
- 27 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder
- ClinicalTrials.gov ID
- NCT00678574
- Acronym / sponsor ID
- 9803010098
- Keywords
- hormones, menses, PMS, PMDD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 1998
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Posted 17 Jul 2017
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 the study proposed is to investigate the role of neurosteroids and GABA in the pathophysiology and treatment of premenstrual dysphoric disorder (PMDD) by 1) measuring cortical gama-aminobutyric acid levels (GABA levels) using nuclear magnetic resonance spectroscopy (MRS) during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the selective serotonin reuptake inhibitor (SSRI) fluoxetine (Prozac®, Sarafem®), and 2) correlating cerebrospinal fluid (CSF) and plasma GABA and neurosteroid levels with cortical GABA levels at these same time points. Neurosteroids to be measured include allopregnanolone, pregnenolone, and pregnenolone sulfate. Findings from women with PMDD will be compared to those of healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premenstrual Dysphoric Disorder (PMDD) group | Experimental | Drug: fluoxetinePMDD group received fluoxetine 20 mg daily by mouth for 2-3 months |
| Healthy controls | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18 - 45 years old and able to give voluntary written informed consent.
- Willing to complete a daily log of mood symptoms for 7 consecutive menstrual cycles: two menstrual cycles during the Screening Phase (Phase 1), one menstrual cycle during the Testing Phase (Phase 2), and four menstrual cycles during the Medication Treatment Phase and Post-Treatment Phase (Phase 3). All subjects who successfully complete Phases 1 and 2, and the Medication Treatment Phase, will be invited to participate in Phase 3 approximately three months later. Phase 3 will involve repeating all procedures conducted in Phase 2, including the daily log of mood symptoms.
- Meet DSM-IV criteria for premenstrual dysphoric disorder, confirmed by the Daily Record of Severity of Problems (DRSP; Endicott \& Harrison) for 2 consecutive menstrual cycles (Phase 1). The DRSP is a self-rated symptom checklist, which requires individuals to rate their symptoms of PMDD according to the DSM-IV research criteria scale on a scale from 1 (symptom not present) to 6 (symptom extreme). During the last 7 days of the menstrual cycle compared to days 5-11, patients must have a 30% increase in their average (over 2 menstrual cycles) score for 5 of these 10 symptoms. Symptoms must be "not present" or "minimal" during the postmenstrual week.
- Average 19-item Hamilton Depression Rating Scale (HAM-D) scores < 5 during the follicular phase and > 16 during the luteal phase.
- Have regular menstrual cycles 28 to 32 days in length. Each of the screening cycles must be ovulatory as confirmed by plasma progesterone levels of >5 ng/ml during the luteal phase.
Key exclusion criteria (9 listed)
- Presence of any other comorbid DSM-IV Axis I disorder.
- Meeting DSM-IV criteria for psychoactive substance (excluding nicotine) dependence within the preceding 4 months.
- A history of serious medical or neurological illness, including (but not limited to) major cardiovascular disease, severe hypertension, intracranial mass lesions, seizure disorder, severe hepatic or renal disease, unstable endocrine or metabolic disease, and unstable hematologic disease.
- Use of anticonvulsant or benzodiazepines within the last month.
- Use of psychotropic medication in last week (except as stated above).
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 |
|---|---|---|
| fluoxetineAlso: Prozac, SarafemFluoxetine 20 mg daily by mouth for 2-3 months. | Drug | Premenstrual Dysphoric Disorder (PMDD) group |
Primary outcome
Change in Cortical Gama-aminobutyric Acid Levels (GABA Levels) Pre and Post SSRI Treatment
Time frame: 2-3 months post-treatment w/ fluoxetine.
GABA levels would be assessed during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the SSRI.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Occupational Physicians Facing Premenstrual Dysphoric Disorder: Knowledge, Perceptions and Practices in Occupational Health
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To Establish Whether Individuals With Premenstrual Dysphoric Disorder (PMDD) Demonstrate a Different Luteal-phase Sex Hormone Profile and Ratio Compared With Asymptomatic Controls.
Premenstrual Dysphoric Disorder ( PMDD)
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.
Cynthia N Epperson, MD principal investigator
University of Pennsylvania School of Medicine Department of Psychiatry
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 fluoxetine in people with Premenstrual Dysphoric Disorder and Premenstrual Syndrome, 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 5 inclusion and 9 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 27 Jul 2018. 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 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 17 Jul 2017). 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?
Change in Cortical Gama-aminobutyric Acid Levels (GABA Levels) Pre and Post SSRI Treatment (time frame: 2-3 months post-treatment w/ fluoxetine.). 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 27 Jul 2018.