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Sponsored by: |
Massachusetts General Hospital |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00633360 |
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. |
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 |
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1: Experimental
Drospirenone and ethinyl estradiol
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Drug: Drospirenone and ethinyl estradiol
Once daily by mouth
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2: Placebo Comparator
Placebo
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Drug: Placebo
Once daily by mouth
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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
Contact: Nicole Economou, BA | 617-724-1181 | neconomou@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Principal Investigator: Lee S Cohen, MD |
Principal Investigator: | Lee S Cohen, Md | Massachusetts General Hospital |
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 |
Women PMS Depression |
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 |
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 |