Alternative Treatments for Premenstrual Dysphoric Disorder
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Alternative Treatments for Premenstrual Dysphoric Disorder|
- Treatment-Related Changes from baseline in mood ratings [ Time Frame: baseline (month 2) and 1-2 days post intervention (months 3,5) ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: Yes ]Following each treatment interventions, subjects will complete an assessment of side effects using the Side Effects Checklist.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
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)
The design is a randomized cross-over contrasting Late Wake Therapy plus morning bright light (LWT+Am BWL)vs. Early Wake Therapy plus evening bright light (EWT+PM BWL)administered in the luteal phase of two separate menstrual cycles, and preceded by 2 evaluation months. To lessen the patient's burden, the 1-night EWT or LWT and the following 7-day BWL interventions will be conducted at home, given at a fixed point in each menstrual cycle, from day 1 to 7 after the mid-cycle luteinizing hormone(LH) surge (ovulation). We anticipate that LWT+7 days of AM BWL (vs. EWT+PM BWL) will produce much greater mood benefits and larger physiological responses, than the one-time light pulses used in our earlier phase-shift studies.
Please refer to this study by its ClinicalTrials.gov identifier: 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|