Alternative Treatments for Premenstrual Dysphoric Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-18

Study Completion Date

2018-07-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Premenstrual Syndrome and Premenstrual Dysphoria

NCT00001177

Mood Disorder

RECRUITING

Chronobiological Basis of Menopausal Depression: Correcting Misaligned Circadian Rhythms With Sleep and Light Interventions

NCT06678880

Depression Depression During the Menopausal Transition Menopausal Depression

RECRUITING NA

Combined Hormone Replacement in Menstrually-Related Mood Disorders

NCT00005011

Premenstrual Syndrome Depression

COMPLETED

Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression

NCT06610305

Major Depressive Disorder

RECRUITING PHASE4

Effects of Sex Hormones on Circadian Rhythm in Men and Women

NCT00001285

Bipolar Disorder Circadian Rhythm Depressive Disorder

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Premenstrual Dysphoric Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

The principal investigator and clinical rater will remain blind to treatment condition until completion or discontinuation of participant from study. As patients will be coded, one statistician and technician and supervisor running assays also will be blind to patient name and treatment condition. Members of the Data Safety Monitoring Committee will review records in which patient names are coded, unless the code needs to be broken in the event of an adverse outcome. All other lab personnel will not be blind to treatment as the study coordinator and research associate prepare patient equipment and instruct patients on proper completion of the treatment protocol, the data manager and quality assurance officer enter all data into the database (including treatment condition). Due to the nature of the treatment (sleep, light intervention), patients will not be blind to condition.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LWT+AM BWL

Late-wake therapy in combination with morning bright white light

Group Type ACTIVE_COMPARATOR

LWT+AM BWL

Intervention Type OTHER

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 BWL

Early-wake therapy in combination with evening bright white light

Group Type PLACEBO_COMPARATOR

EWT+PM BWL

Intervention Type OTHER

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type 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)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

* 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.

Exclusion Criteria

* 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.
* 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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No