Alternative Treatments for Premenstrual Dysphoric Disorder (NCT01799733) | Clinical Trial Compass
CompletedNot Applicable
Alternative Treatments for Premenstrual Dysphoric Disorder
United States43 participantsStarted 2013-06-18
Plain-language summary
The primary aim of this study is to examine the effects of co-administered wake therapy followed by light treatment on mood, and secondarily on circadian rhythms, to test the hypothesis that critically-timed chronotherapy improves mood by correcting phase disturbances in melatonin and sleep in women with Premenstrual Dysphoric Disorder.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 18-45 years.
* Women with regular ovulatory menstrual cycles 26-32 days in length (for at least the previous six months).
* A history of a depressive (but not bipolar) mood disorder, but not an ongoing episode (symptom free for the last 12 months).
* Patients must meet DSM-IV criteria for Premenstrual Dysphoric Disorder (that includes irritability).
* Objective ratings: mean HRSD \< 7 for follicular phase (day 5-10 of cycle after menses); mean HRSD \> 14 for premenstrual (luteal) phase (6 days prior to onset of menses onward).
* Subjective ratings: mean Beck Depression Inventory \< 5 follicular phase; \> 10 premenstrual (luteal) phase, or
* Daily ratings: minimal symptoms (mean less than 50 on 100mm scale) follicular phase; at least a 30% increase in mean affective symptom ratings, premenstrual (luteal) phase.
* By clinical assessment and ratings, the patient has reported a history (for at least the last six months) of recurrent, moderate to severe premenstrual mood symptoms that impair some aspect of social or occupational functioning and that remit within a few days after the onset of menses. This pattern is prospectively documented with subjective and objective ratings over a 2-3 month interval. Patients must demonstrate a consistency of symptoms and a long enough duration of symptoms (7-10 days) to allow for study.
* Subjects willing to endure the rigors of a long-term (up to 6 months) research study.
Exclusion Criteria:
* Subjects with signi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment-Related Changes from baseline in mood ratings
Timeframe: baseline (month 2) and 1-2 days post intervention (months 3,5)
2
Treatment-Related Changes from Baseline in Urinary 6-sulfatoxymelatonin (6-SMT)
Timeframe: baseline (month 2) and 1-2 days post intervention (months 3,5)
3
Treatment-related changes in objective and subjective sleep measures
Timeframe: baseline (month 2) and 1-2 days post intervention (months 3,5)