The Oral Contraceptive Pill for Premenstrual Worsening of Depression

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00633360
• Date of registration: 04/03/2008
• Prospective Registration: No
• Primary sponsor: Massachusetts General Hospital
• Public title: The Oral Contraceptive Pill for Premenstrual Worsening of Depression
• Scientific title: The Oral Contraceptive Pill for Premenstrual Worsening of Depression.
• Date of first enrolment: February 2008
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00633360
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Hadine Joffe, MD MSc
• Affiliation: Brigham and Women's Hospital

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Premenstrual Syndrome

Depression

Intervention(s)

Drug: Drospirenone and ethinyl estradiol

Drug: Placebo

Primary Outcome(s)

Percent Change in Luteal Montgomery-Asberg Depression Rating Scale (MADRS) [Time Frame: Baseline and 2 months]

Secondary Outcome(s)

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

Secondary ID(s)

2007-P-002057

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bayer

Results

• Results available: Yes
• Date Posted: 20/03/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00633360