Alternative Treatments for Premenstrual Dysphoric Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01799733|
Recruitment Status : Recruiting
First Posted : February 27, 2013
Last Update Posted : January 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Premenstrual Dysphoric Disorder||Other: LWT+AM BWL Other: EWT+PM BWL||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Alternative Treatments for Premenstrual Dysphoric Disorder|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Active Comparator: LWT+AM BWL
Late-wake therapy in combination with morning bright white light
Other: LWT+AM BWL
One night of late wake therapy (LWT)(sleep 21:00-01:00 h, followed by wakefulness) plus 7 days of morning bright white light (AM BWL)(light-emitting diode-LED administered for 60 minutes, starting within 30 minutes of habitual wake time)
Placebo Comparator: EWT+PM BWL
Early-wake therapy in combination with evening bright white light
Other: EWT+PM BWL
One night of early wake therapy (EWT) (wakefulness until 03:00 h, then sleep 03:00-07:00 h) plus 7 nights of evening bright white light (PM BWL)(light-emitting diode-LED administered 90 minutes before habitual sleep onset, for 60 minutes)
- Treatment-Related Changes from baseline in mood ratings [ Time Frame: baseline (month 2) and 1-2 days post intervention (months 3,5) ]Mood ratings include Hamilton Rating Scale for Depression (HRSD), Beck Depression Inventory (BDI), atypical depression symptoms as part of the Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorders version (SIGH-SAD), Beck Anxiety Inventory (BAI), mania ratings, the Psychological General Well-Being Index (PGWI) and daily mood self-ratings (DMR) that include core PMDD symptoms of anxiety and irritability as required during diagnostic evaluation, before, during and after each wake and light intervention at the same time of day (between 15:00-17:00 h). To assess more acute effects on mood that may occur more rapidly during the wake interventions, subjects will complete DMRs twice daily beginning the evening before the wake therapy intervention and continuing until the morning after the recovery night of sleep.
- Treatment-Related Changes from Baseline in Urinary 6-sulfatoxymelatonin (6-SMT) [ Time Frame: baseline (month 2) and 1-2 days post intervention (months 3,5) ]6-SMT is a principal melatonin metabolite that is abundant in urine, well correlated with plasma melatonin, and serves as an excellent marker for circadian phase response.
- Treatment-related changes in objective and subjective sleep measures [ Time Frame: baseline (month 2) and 1-2 days post intervention (months 3,5) ]Using actigraphy, we will obtain objective measures of the sleep/wake cycle to ensure appropriate sleep/wake times during wake therapy, and during the light interventions as it is an important biological rhythm with which to compare the intervention-induced melatonin rhythm changes. To assess subjective sleep quality, we will use the Pittsburgh Sleep Quality Index (PSQI) and a visual analogue scale.
- Effects of expectation, morningness/eveningness and seasonality on primary outcome measures [ Time Frame: baseline ]Prior to entering the study, subjects will complete expectation forms measuring their expectation for change with the interventions (100 mm line from "much worse" to "much better") as well as Horne-Östberg scales to assess morningness and eveningness, as these variables may mediate or moderate primary outcome measures. To determine whether seasonality affects outcome, subjects will complete the Seasonal Pattern Assessment Questionnaire (SPAQ).
- Treatment-related changes from baseline in reproductive hormones [ Time Frame: baseline (month 2) and 1-2 days post intervention (months 3,5) ]We will obtain overnight urinary samples for estradiol, progesterone, gonadotropins and prolactin (obtained at the same time of 6-SMT overnight collections in baseline and intervention months).
- Subjective visual analog scale-based global assessment of treatment effectiveness [ Time Frame: 1-2 days post second intervention (month 5) ]Following both treatment interventions, subjects will complete a visual analog scale-based global assessment of treatment effectiveness.
- Subjective assessment of side effects to treatment [ Time Frame: 1-2 days post intervention (months 3,5) ]Following each treatment interventions, subjects will complete an assessment of side effects using the Side Effects Checklist.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799733
|Contact: Diane L Sorenson, MPHemail@example.com|
|Contact: Luis F Martinez, B.A.||firstname.lastname@example.org|
|United States, California|
|UCSD Medical Center, Hillcrest||Recruiting|
|San Diego, California, United States, 92103|
|Contact: Diane L Sorenson, MPH 619-543-5575 email@example.com|
|Contact: Luis F Martinez, B.A. 619-507-1182 firstname.lastname@example.org|
|Principal Investigator: Barbara L Parry, M.D.|
|Sub-Investigator: Charles J Meliska, Ph.D.|
|Sub-Investigator: Richard Hauger, M.D.|
|Sub-Investigator: Shah Golshan, Ph.D.|
|Principal Investigator:||Barbara L Parry, M.D.||University of California, San Diego|