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The Oral Contraceptive Pill for Premenstrual Worsening of Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hadine Joffe, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00633360
First received: March 4, 2008
Last updated: July 9, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Massachusetts General Hospital:

Primary Outcome Measures:
  • Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-rate Daily Record of Severity of Problems (DSRP) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 99
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: 1
Drospirenone and ethinyl estradiol
Drug: Drospirenone and ethinyl estradiol
Once daily by mouth
Other Name: Yaz
Placebo Comparator: 2
Placebo
Drug: Placebo
Once daily by mouth

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633360

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

Additional Information:
No publications provided

Responsible Party: Hadine Joffe, MD, Director of Women's Mental Health Division, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00633360     History of Changes
Other Study ID Numbers: 2007-P-002057
Study First Received: March 4, 2008
Last Updated: July 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Women
PMS
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Premenstrual Syndrome
Behavioral Symptoms
Menstruation Disturbances
Mental Disorders
Mood Disorders
Pathologic Processes
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Drospirenone
Drospirenone and ethinyl estradiol combination
Estradiol
Ethinyl Estradiol
Cardiovascular Agents
Contraceptive Agents, Female
Diuretics
Diuretics, Potassium Sparing
Estrogens
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014