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| Sponsor: | 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. |
| 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 |
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
Contacts and Locations| 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 |
More Information
| 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 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 |