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The Oral Contraceptive Pill for Premenstrual Worsening of Depression
This study is currently recruiting participants.
Verified by Massachusetts General Hospital, September 2009
First Received: March 4, 2008   Last Updated: September 8, 2009   History of Changes
Sponsored by: Massachusetts General Hospital
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00633360
  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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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 ]

Estimated Enrollment: 103
Study Start Date: February 2008
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Drospirenone and ethinyl estradiol
Drug: Drospirenone and ethinyl estradiol
Once daily by mouth
2: Placebo Comparator
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 SSRI/SNRI 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. Depressive disorders will be in remission for at least 2 months, with the exception of transient re-emergence of depressive symptoms during the premenstrual week;
  4. Use of an SSRI or SNRI 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 antidepressant medication as long as one of the antidepressant medications is either an SSRI or a SNRI.
  5. Expected continued use of the same antidepressant at the same dose for the duration of the study;
  6. Greater than 50% increase in the total Daily Record of Severity of Problems Scale (DRSP) score from the mid-follicular (average of DRSP scores for days 6-10) to the late-luteal (average of DRSP scores for last 5 days prior to menstrual bleeding) phase. This will be assessed prospectively during the initial run-in phase of the study over 2 menstrual cycles;11
  7. Late-luteal phase Montgomery-Åsberg Depression Rating Scale (MADRS) score >13 (but no greater than 31), as has been used in other studies as the minimum score suggesting mild depression; This will be assessed prospectively during the initial run-in phase of the study over 2 menstrual cycles;11
  8. Mid-follicular phase MADRS score less than 10, a score suggesting absence of depression, as has been used in other studies. This will be assessed prospectively during a run-in phase of the study over 2 menstrual cycles;11
  9. Normal pelvic exam and PAP smear in the past 12 months;
  10. 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;
  11. Negative serum HCG at baseline, and negative urine HCG at visits 3 and 5;
  12. Willingness to use barrier contraceptive methods during the study, if sexually active;
  13. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633360

Contacts
Contact: Nicole Economou, BA 617-724-1181 neconomou@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Lee S Cohen, MD            
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Lee S Cohen, Md Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Massachusetts General Hospital ( Lee S. Cohen, MD )
Study ID Numbers: 2007-P-002057
Study First Received: March 4, 2008
Last Updated: September 8, 2009
ClinicalTrials.gov Identifier: NCT00633360     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Women
PMS
Depression

Study placed in the following topic categories:
Estrogens
Depression
Contraceptive Agents
Hormone Antagonists
Estradiol valerate
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Ethinyl Estradiol
Estradiol 17 beta-cypionate
Depressive Disorder
Hormones
Estradiol
Behavioral Symptoms
Aldosterone Antagonists
Menstruation Disturbances
Mental Disorders
Estradiol 3-benzoate
Drospirenone
Mood Disorders
Polyestradiol phosphate
Premenstrual Syndrome

Additional relevant MeSH terms:
Estrogens
Depression
Disease
Contraceptive Agents
Hormone Antagonists
Physiological Effects of Drugs
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Ethinyl Estradiol
Reproductive Control Agents
Depressive Disorder
Hormones
Pharmacologic Actions
Behavioral Symptoms
Pathologic Processes
Aldosterone Antagonists
Menstruation Disturbances
Mental Disorders
Therapeutic Uses
Syndrome
Drospirenone
Mood Disorders
Premenstrual Syndrome

ClinicalTrials.gov processed this record on September 10, 2009