Premenstrual Dysphoric DisorderNCT01799733
Alternative Treatments for Premenstrual Dysphoric Disorder
A study testing LWT+AM BWL and EWT+PM BWL in people with Premenstrual Dysphoric Disorder, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Premenstrual Dysphoric Disorder
- What is being tested?
- LWT+AM BWL and EWT+PM BWL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2013to 3 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- Subjects with significant medical illness including hepatic (abnormal liver function tests), neurological, renal, cardiac, pulmonary, hematologic, gastrointestinal, or metabolic disorders.
- Subjects who are lactating, are within 6 months postpartum, or have an irregular sleep- wake cycle, e.g., from having very young children in the home.
- Subjects who are using hormonal contraception (within six months prior to the study).
- Subjects using other medication within one month of initiating the study or anytime during the study.
- Subjects with significant psychiatric disorder (schizophrenia, bipolar disorder, anxiety disorders, eating disorders, personality disorders, sleep disorders). An ongoing major depressive episode within the last year is reason for exclusion, although a previous history of a depressive episode is not (using DSM-IV diagnostic criteria for a major depressive episode).
- Subjects with a recent history (within the past year) of drug or alcohol abuse.
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- Subjects with clinically significant abnormal laboratory values.
- Subjects with irregular menstrual cycles (cycle lengths vary greater than 3 days).
- Subjects unlikely to cooperate with the requirements of the study.
- Subjects needing frequent or continuous use of any medication, including nicotine (> 5 cigarettes daily).
- Subjects whose prospective ratings do not show cyclic variation in association with the menstrual cycle (as per inclusion criteria).
- Subjects with an irregular sleep schedule, extreme chronotypes or a sleep-wake cycle that does not correspond to the environmental light-dark cycle (e.g., subjects within 2 weeks of transmeridian travel, night shift workers, or those with significant advanced or delayed sleep phase syndromes). To enhance precision of the timing of the light stimulus on circadian phase (temporal resolution), we will exclude women with habitual sleep onset times after midnight or wake times after 9 am.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Medical Center, Hillcrest
San Diego, California, 92103
About this study
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.
Read the detailed description
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.
- Conditions
- Premenstrual Dysphoric Disorder
- Being tested
- LWT+AM BWL, EWT+PM BWL
- Keywords
- Premenstrual Dysphoric Disorder, Women, Depression, Light therapy, Wake therapy, Phase, Chronobiology
- Medical subject headings
- Premenstrual Dysphoric Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LWT+AM BWLOther
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)
EWT+PM BWLOther
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)
| Study group | Role | What they receive |
|---|---|---|
| LWT+AM BWL | Active comparator | Late-wake therapy in combination with morning bright white light Receives: Other: LWT+AM BWL |
| EWT+PM BWL | Placebo comparator | Early-wake therapy in combination with evening bright white light Receives: Other: EWT+PM BWL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Related Changes from baseline in mood ratings
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.
Measured: baseline (month 2) and 1-2 days post intervention (months 3,5)
Treatment-Related Changes from Baseline in Urinary 6-sulfatoxymelatonin (6-SMT)
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.
Measured: baseline (month 2) and 1-2 days post intervention (months 3,5)
Treatment-related changes in objective and subjective sleep measures
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.
Measured: baseline (month 2) and 1-2 days post intervention (months 3,5)
Secondary outcomes (4)
Effects of expectation, morningness/eveningness and seasonality on primary outcome measures
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).
Measured: baseline
Treatment-related changes from baseline in reproductive hormones
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).
Measured: baseline (month 2) and 1-2 days post intervention (months 3,5)
Subjective visual analog scale-based global assessment of treatment effectiveness
Following both treatment interventions, subjects will complete a visual analog scale-based global assessment of treatment effectiveness.
Measured: 1-2 days post second intervention (month 5)
Subjective assessment of side effects to treatment
Following each treatment interventions, subjects will complete an assessment of side effects using the Side Effects Checklist.
Measured: 1-2 days post intervention (months 3,5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study start18 Jun 2013
- Primary completion10 May 2018
- Study completion3 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premenstrual Dysphoric DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 40 women with Premenstrual Dysphoric Disorder ages 18-45 will be randomized to a cross-over design contrasting one night of Late Wake Therapy followed by 7 days of morning Bright-White Light (LWT+AM BWL) vs. one night of Early Wake Therapy followed by evening Bright-White Light (EWT+PM BWL) administered in the luteal phase of two separate menstrual cycles, with one month of no intervention (washout) between treatments to prevent carry-over effects. Treatment will be preceded by 2 evaluation months to determine diagnosis and collect baseline mood, sleep, actigraphy and endocrine measures. 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 the day of mid-cycle LH surge to 7 after the LH surge.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara L. Parry, M.D., University of California, San Diego
- Investigators
- Barbara L Parry, M.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799733
- Sponsor's protocol ID
- 1R01AT007169-01A1
- Status last verified
- Jan 2022
- First submitted
- 25 Feb 2013
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Parry BL, Meliska CJ, Martinez LF, Lopez AM, Sorenson DL, Dawes SE, Elliott JA, Hauger RL. A 1-week sleep and light intervention improves mood in premenstrual dysphoric disorder in association with shifting melatonin offset time earlier. Arch Womens Ment Health. 2023 Feb;26(1):29-37. doi: 10.1007/s00737-022-01283-z. Epub 2022 Dec 15.
PubMed 36520251
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Treatments for Premenstrual Dysphoric Disorder
- ClinicalTrials.gov ID
- NCT01799733
- Acronym / sponsor ID
- 1R01AT007169-01A1
- Conditions
- Premenstrual Dysphoric Disorder
- Keywords
- Premenstrual Dysphoric Disorder, Women, Depression, Light therapy, Wake therapy, Phase, Chronobiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 18 Jun 2013 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 27 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 40 women with Premenstrual Dysphoric Disorder ages 18-45 will be randomized to a cross-over design contrasting one night of Late Wake Therapy followed by 7 days of morning Bright-White Light (LWT+AM BWL) vs. one night of Early Wake Therapy followed by evening Bright-White Light (EWT+PM BWL) administered in the luteal phase of two separate menstrual cycles, with one month of no intervention (washout) between treatments to prevent carry-over effects. Treatment will be preceded by 2 evaluation months to determine diagnosis and collect baseline mood, sleep, actigraphy and endocrine measures. 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 the day of mid-cycle LH surge to 7 after the LH surge.
| Arm | Type | Receives |
|---|---|---|
| LWT+AM BWL | Active comparator | Other: LWT+AM BWLLate-wake therapy in combination with morning bright white light |
| EWT+PM BWL | Placebo comparator | Other: EWT+PM BWLEarly-wake therapy in combination with evening bright white light |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (12 listed)
- Subjects with significant medical illness including hepatic (abnormal liver function tests), neurological, renal, cardiac, pulmonary, hematologic, gastrointestinal, or metabolic disorders.
- Subjects who are lactating, are within 6 months postpartum, or have an irregular sleep- wake cycle, e.g., from having very young children in the home.
- Subjects who are using hormonal contraception (within six months prior to the study).
- Subjects using other medication within one month of initiating the study or anytime during the study.
- Subjects with significant psychiatric disorder (schizophrenia, bipolar disorder, anxiety disorders, eating disorders, personality disorders, sleep disorders). An ongoing major depressive episode within the last year is reason for exclusion, although a previous history of a depressive episode is not (using DSM-IV diagnostic criteria for a major depressive episode).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LWT+AM BWLOne 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) | Other | LWT+AM BWL |
| EWT+PM BWLOne 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) | Other | EWT+PM BWL |
Primary outcome
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.
4 secondary outcomes
Effects of expectation, morningness/eveningness and seasonality on primary outcome measures
Time frame: baseline
Treatment-related changes from baseline in reproductive hormones
Time frame: baseline (month 2) and 1-2 days post intervention (months 3,5)
Subjective visual analog scale-based global assessment of treatment effectiveness
Time frame: 1-2 days post second intervention (month 5)
Subjective assessment of side effects to treatment
Time frame: 1-2 days post intervention (months 3,5)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Derived from this study: PubMed 36520251Parry BL, Meliska CJ, Martinez LF, Lopez AM, Sorenson DL, Dawes SE, Elliott JA, Hauger RL. A 1-week sleep and light intervention improves mood in premenstrual dysphoric disorder in association with shifting melatonin offset time earlier. Arch Womens Ment Health. 2023 Feb;26(1):29-37. doi: 10.1007/s00737-022-01283-z. Epub 2022 Dec 15.
- Individual participant dataSharing planned: No
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Premenstrual Dysphoric Disorder ( PMDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara L Parry, M.D. principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LWT+AM BWL and EWT+PM BWL in people with Premenstrual Dysphoric Disorder, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-Related Changes from baseline in mood ratings (time frame: baseline (month 2) and 1-2 days post intervention (months 3,5)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01799733, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.