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The Oral Contraceptive Pill for Premenstrual Worsening of Depression

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ClinicalTrials.gov Identifier: NCT00633360
Recruitment Status : Completed
First Posted : March 12, 2008
Results First Posted : March 20, 2017
Last Update Posted : March 20, 2017
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Hadine Joffe, MD, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE March 4, 2008
First Posted Date  ICMJE March 12, 2008
Results First Submitted Date  ICMJE June 24, 2016
Results First Posted Date  ICMJE March 20, 2017
Last Update Posted Date March 20, 2017
Study Start Date  ICMJE February 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2008)
Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 2 months ]
Change History Complete list of historical versions of study NCT00633360 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2008)
Self-rate Daily Record of Severity of Problems (DSRP) [ Time Frame: 2 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Oral Contraceptive Pill for Premenstrual Worsening of Depression
Official Title  ICMJE The Oral Contraceptive Pill for Premenstrual Worsening of Depression.
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Premenstrual Syndrome
  • Depression
Intervention  ICMJE
  • Drug: Drospirenone and ethinyl estradiol
    Once daily by mouth
    Other Name: Yaz
  • Drug: Placebo
    Once daily by mouth
Study Arms  ICMJE
  • Experimental: Drospirenone and ethinyl estradiol
    Intervention: Drug: Drospirenone and ethinyl estradiol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2017)
32
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2008)
103
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00633360
Other Study ID Numbers  ICMJE 2007-P-002057
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hadine Joffe, MD, Brigham and Women's Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Bayer
Investigators  ICMJE
Principal Investigator: Hadine Joffe, MD MSc Brigham and Women's Hospital
PRS Account Massachusetts General Hospital
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP