Premenstrual SyndromeNCT00633360
The Oral Contraceptive Pill for Premenstrual Worsening of Depression
A study testing Drospirenone and ethinyl estradiol in people with Premenstrual Syndrome and Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
To determine if augmentation with the oral-contraceptive pill containing drospirenone and ethinyl estradiol is more effective than placebo in the treatment of premenstrual breakthrough of depression. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Premenstrual Syndrome, Depression
- What is being tested?
- Drospirenone and ethinyl estradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to May 2011
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Women who are non-smokers between the ages of 18-45 years (smokers 18-34 years);
- Regular menstrual cycles (26-34 days in length, predictable within 7 days) for the past 6 months;
- Determination that the antidepressant medication was initiated for the treatment of unipolar major depression, minor depression (depression, not otherwise specified), or dysthymia. Major depression and dysthymia will be evaluated through administration of the Mini-International Neuropsychiatric Interview (MINI). Minor depression will be evaluated by administration of the Structured Clinical Interview for Diagnosis-IV(SCID)10 section J.3.
- Use of an antidepressant for at least 3 months for treatment of a depressive disorder, with stable dose for at least 2 months. It is acceptable to be on more than one psychiatric medication as long as one of them is an antidepressant.
- Expected continued use of the same antidepressant at the same dose for the duration of the study;
- 30% increase of the mid-follicular phase Montgomery-Åsberg Depression Rating Scale (MADRS) score to the late-luteal phase MADRS will be required for eligibility during the tracking phase of the study and will be assessed prospectively over 1 menstrual cycle.
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- Normal pelvic exam and PAP smear in the past 12 months;
- Normal TSH at screen - if on thyroid medication, must be on a stable dose for 2 months or greater, and have a normal TSH at screen;
- Negative serum HCG at baseline, and negative urine HCG at visits 3 and 5;
- Normal potassium (K) levels at screen;
- Willingness to use barrier contraceptive methods during the study, if sexually active;
- Good general health.
Who cannot join
- Amenorrhea or irregular menstrual periods (defined as unable to predict within 7 days) during past 6 months
- Pregnancy or breastfeeding (serum HCG test administered at baseline study visit, and urine HCG at visits 3 and 5)
- Current cigarette smoking in women who are older than 34 years
- Presence of any of the following psychiatric and substance use disorders, based on administration of the MINI at the baseline study visit:
- Any history of mania or hypomania suggesting bipolar disorder Any lifetime history of a psychotic disorder
- Depression deemed by the physician investigator to be too severe to be treated in the study
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- Use of benzodiazepines or antipsychotic to target premenstrual symptoms
- Luteal-phase dose adjustment of the antidepressant. Use of a hormone releasing IUD (intrauterine device)
- Use of an OCP or other systemic hormonal therapies (oral, transdermal or injection preparations of androgens, estrogens, or progestins) in the past 2 months;
- Any contraindication or previous adverse event to any OCP therapy;
- Current use of ketoconazole, rifampin, carbamazepine, topiramate, oxcarbazepine, modafinil, phenytoin, or phenobarbital (because of interaction with hormonal therapy).
- Current use of potassium-sparing agents, such as potassium-sparing diuretics (e.g., spironolactone), ACE inhibitors, angiotensin-II receptor antagonists, heparin, aldosterone antagonists, NSAIDS, potassium sparing diuretics or potassium-supplements (because of risk of developing arrhythmia with two potassium-elevating agents).
- Hepatic dysfunction, renal insufficiency, pulmonary, adrenal, or metabolic diseases (including elevated serum potassium levels, if known) that may put subject at risk when treated with study medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: The Oral Contraceptive Pill for Premenstrual Worsening of Depression.
To determine if augmentation with the oral-contraceptive pill containing drospirenone and ethinyl estradiol is more effective than placebo in the treatment of premenstrual breakthrough of depression.
- Conditions
- Premenstrual Syndrome, Depression
- Being tested
- Drospirenone and ethinyl estradiol, Placebo
- Keywords
- Women, PMS, Depression
- Medical subject headings
- Premenstrual Syndrome, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drospirenone and ethinyl estradiolDrug
Also called Yaz
Once daily by mouth
PlaceboDrug
Once daily by mouth
| Study group | Role | What they receive |
|---|---|---|
| Drospirenone and ethinyl estradiol | Experimental | Not described Receives: Drug: Drospirenone and ethinyl estradiol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Luteal Montgomery-Asberg Depression Rating Scale (MADRS)
The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and during 2nd treatment month in order to calculate the change in MADRS score.
Measured: Baseline and 2 months
Secondary outcomes (1)
Percent Change in Daily Record of Severity of Problems (DRSP)
The DRSP is a 24-item self-administered daily dairy that assesses the severity of mood and physical symptoms which occur as part of the premenstrual syndrome and PMDD. Each question is rated on a scale of 1-6 with a total score range from 24-144. A higher score indicates greater symptom burden.
Measured: Baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2011
- Study completionMay 2011
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 SyndromeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Hadine Joffe, MD, Brigham and Women's Hospital
- Investigators
- Hadine Joffe, MD MSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633360
- Sponsor's protocol ID
- 2007-P-002057
- Status last verified
- Jan 2017
- First submitted
- 4 Mar 2008
- Last updated
- 20 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oral Contraceptive Pill for Premenstrual Worsening of Depression.
- ClinicalTrials.gov ID
- NCT00633360
- Acronym / sponsor ID
- 2007-P-002057
- Conditions
- Premenstrual Syndrome, Depression
- Keywords
- Women, PMS, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Feb 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 12 Mar 2008 (estimated)
- Results
- Posted 20 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if augmentation with the oral-contraceptive pill containing drospirenone and ethinyl estradiol is more effective than placebo in the treatment of premenstrual breakthrough of depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drospirenone and ethinyl estradiol | Experimental | Drug: Drospirenone and ethinyl estradiol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Women who are non-smokers between the ages of 18-45 years (smokers 18-34 years);
- Regular menstrual cycles (26-34 days in length, predictable within 7 days) for the past 6 months;
- Determination that the antidepressant medication was initiated for the treatment of unipolar major depression, minor depression (depression, not otherwise specified), or dysthymia. Major depression and dysthymia will be evaluated through administration of the Mini-International Neuropsychiatric Interview (MINI). Minor depression will be evaluated by administration of the Structured Clinical Interview for Diagnosis-IV(SCID)10 section J.3.
- Use of an antidepressant for at least 3 months for treatment of a depressive disorder, with stable dose for at least 2 months. It is acceptable to be on more than one psychiatric medication as long as one of them is an antidepressant.
- Expected continued use of the same antidepressant at the same dose for the duration of the study;
Key exclusion criteria (13 listed)
- Amenorrhea or irregular menstrual periods (defined as unable to predict within 7 days) during past 6 months
- Pregnancy or breastfeeding (serum HCG test administered at baseline study visit, and urine HCG at visits 3 and 5)
- Current cigarette smoking in women who are older than 34 years
- Presence of any of the following psychiatric and substance use disorders, based on administration of the MINI at the baseline study visit:
- Any history of mania or hypomania suggesting bipolar disorder Any lifetime history of a psychotic disorder
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 |
|---|---|---|
| Drospirenone and ethinyl estradiolAlso: YazOnce daily by mouth | Drug | Drospirenone and ethinyl estradiol |
| PlaceboOnce daily by mouth | Drug | Placebo |
Primary outcome
Percent Change in Luteal Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Baseline and 2 months
The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and during 2nd treatment month in order to calculate the change in MADRS score.
1 secondary outcome
Percent Change in Daily Record of Severity of Problems (DRSP)
Time frame: Baseline and 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Hadine Joffe, MD MSc principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drospirenone and ethinyl estradiol in people with Premenstrual Syndrome and Depression, run by Massachusetts General Hospital 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 12 inclusion and 13 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 20 Mar 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 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?
Percent Change in Luteal Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Baseline and 2 months). 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 20 Mar 2017.