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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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | The Oral Contraceptive Pill for Premenstrual Worsening of Depression. |
| Estimated Enrollment: | 103 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Drospirenone and ethinyl estradiol
|
Drug: Drospirenone and ethinyl estradiol
Once daily by mouth
Other Name: Yaz
|
|
Placebo Comparator: 2
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| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Lee S Cohen, Md | Massachusetts General Hospital |
More Information
| Responsible Party: | Lee S. Cohen, MD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00633360 History of Changes |
| Other Study ID Numbers: | 2007-P-002057 |
| Study First Received: | March 4, 2008 |
| Last Updated: | July 20, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Women PMS Depression |
|
Depression Depressive Disorder Premenstrual Syndrome Behavioral Symptoms Mood Disorders Mental Disorders Menstruation Disturbances Pathologic Processes Contraceptive Agents Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Contraceptives, Oral Contraceptives, Oral, Combined |
Estradiol Polyestradiol phosphate Ethinyl Estradiol Drospirenone Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Aldosterone Antagonists Hormone Antagonists |