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The Oral Contraceptive Pill for Premenstrual Worsening of Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00633360
First Posted: March 12, 2008
Last Update Posted: March 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bayer
Information provided by (Responsible Party):
Hadine Joffe, MD, Brigham and Women's Hospital
  Purpose
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.

Condition Intervention
Premenstrual Syndrome Depression Drug: Drospirenone and ethinyl estradiol Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Oral Contraceptive Pill for Premenstrual Worsening of Depression.

Resource links provided by NLM:


Further study details as provided by Hadine Joffe, MD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Percent Change in Daily Record of Severity of Problems (DRSP) [ Time Frame: Baseline and 2 months ]
    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.


Enrollment: 32
Study Start Date: February 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drospirenone and ethinyl estradiol Drug: Drospirenone and ethinyl estradiol
Once daily by mouth
Other Name: Yaz
Placebo Comparator: Placebo Drug: Placebo
Once daily by mouth

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Women who are non-smokers between the ages of 18-45 years (smokers 18-34 years);
  2. Regular menstrual cycles (26-34 days in length, predictable within 7 days) for the past 6 months;
  3. 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.
  4. 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.
  5. Expected continued use of the same antidepressant at the same dose for the duration of the study;
  6. 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.
  7. Normal pelvic exam and PAP smear in the past 12 months;
  8. 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;
  9. Negative serum HCG at baseline, and negative urine HCG at visits 3 and 5;
  10. Normal potassium (K) levels at screen;
  11. Willingness to use barrier contraceptive methods during the study, if sexually active;
  12. Good general health.

Exclusion Criteria:

  1. Amenorrhea or irregular menstrual periods (defined as unable to predict within 7 days) during past 6 months
  2. Pregnancy or breastfeeding (serum HCG test administered at baseline study visit, and urine HCG at visits 3 and 5)
  3. Current cigarette smoking in women who are older than 34 years
  4. 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

  5. Depression deemed by the physician investigator to be too severe to be treated in the study
  6. Use of benzodiazepines or antipsychotic to target premenstrual symptoms
  7. Luteal-phase dose adjustment of the antidepressant. Use of a hormone releasing IUD (intrauterine device)
  8. Use of an OCP or other systemic hormonal therapies (oral, transdermal or injection preparations of androgens, estrogens, or progestins) in the past 2 months;
  9. Any contraindication or previous adverse event to any OCP therapy;
  10. Current use of ketoconazole, rifampin, carbamazepine, topiramate, oxcarbazepine, modafinil, phenytoin, or phenobarbital (because of interaction with hormonal therapy).
  11. 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).
  12. 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633360


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Bayer
Investigators
Principal Investigator: Hadine Joffe, MD MSc Brigham and Women's Hospital
  More Information

Responsible Party: Hadine Joffe, MD, Vice Chair for Research, Psychiatry Department, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00633360     History of Changes
Other Study ID Numbers: 2007-P-002057
First Submitted: March 4, 2008
First Posted: March 12, 2008
Results First Submitted: June 24, 2016
Results First Posted: March 20, 2017
Last Update Posted: March 20, 2017
Last Verified: January 2017

Keywords provided by Hadine Joffe, MD, Brigham and Women's Hospital:
Women
PMS
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Premenstrual Syndrome
Behavioral Symptoms
Mood Disorders
Mental Disorders
Menstruation Disturbances
Pathologic Processes
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Drospirenone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Contraceptive Agents
Drospirenone and ethinyl estradiol combination
Contraceptives, Oral
Contraceptives, Oral, Combined
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents