- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03010488
Are Bright Lights and Regulated Sleep Effective Treatment for Depression?
Are Bright Lights and Regulated Sleep Effective Treatment for Depression.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will investigate the utility of regimented sleep and lights in depressed subjects. Based on current timing of sleep, desired sleep time and responses to the Morningness-Eveningness Questionnaire, each subject who remains significantly depressed at their randomization (usually 2nd) visit, will be randomly assigned to one of two regimented sleep and light use protocols. On the night beginning their assigned regimented protocol, each subject will wear amber goggles for five hours and collect half hourly saliva samples for four hours. Each morning they will sit in front of a light box wearing goggles. During the first week following the start of the regimented protocol, they will complete self-report forms and have a telephone interview to document their depressive symptoms. They will have weekly in person interviews for six weeks and evaluations by an independent evaluator in person or by telephone at randomization, 2 and 6 weeks. Prior to their Week 2 Visit, they will wear the goggles for the four hours prior to their assigned bedtime and for the three hours prior to their assigned bedtime, they will collect half hourly saliva samples. At their Week 6 interview, they and their doctor will determine whether they have improved sufficiently or not. Their doctor will discuss with them whether it makes sense for them to continue the same regimented sleep/light schedule, make a change to it or switch to or add additional treatment, such as antidepressant medication. They will then be followed with study ratings monthly for six months, during which treatment is unrestricted; that is, the doctor and patient can determine what the treatment during this time will be. Following the six months follow-up, a referral will be made if appropriate.
All saliva samples will be analyzed for melatonin concentration.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Depression Evaluation Service - New York State Psychiatric Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Currently Depressed
- In reasonably good physical health
Exclusion Criteria:
- Bipolar Disorder (I, II, or unspecified)
- History of psychosis
- Unstable medical condition
- Current (past 6 months) drug or alcohol use disorder
- Need for hospitalization
- Treating clinician determines not to include patient in this protocol
- Currently taking medications approved for the treatment of depression
- Un- or poorly controlled hypertension
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Rapid Sleep Shift
Assigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing goggles.
|
10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.
Other Names:
Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.
Other Names:
Subjects will wear goggles during saliva collection and Bright Light Therapy
|
ACTIVE_COMPARATOR: Gradual Sleep Shift
Assigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing goggles.
|
10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.
Other Names:
Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.
Other Names:
Subjects will wear goggles during saliva collection and Bright Light Therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
17-Item Hamilton Rating Scale for Depression Score (Independent Evaluator)
Time Frame: Week 6
|
Independent Evaluator's Week 6 17-item Hamilton Rating Scale for Depression Summary Score. The 17-item Hamilton is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. Although the Hamilton list 24 items, the scoring is based on both the first 17 items and the full 24 items. sum of the scores of the first 17 items (range from 0 to 54): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression >=23 = Very Severe Depression |
Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant Sleep Efficiency
Time Frame: Week 6
|
Sleep Efficiency (percentage of time spent sleeping during target sleep period) as measured by activity monitor and sleep logs. Sleep logs: Patients were instructed to record all sleep periods in the daily log by marking boxes representing 15-minute intervals. They were also requested to wear the Actigraph activity monitor at all times except for bathing, swimming, or any other activities requiring immersion of the wrist. In addition, patients were provided with schedules delineating their allowed sleep time each day. Patients chose their target sleep times (an eight-hour time they desired their sleep to occur) and completed the Morningness-Eveningness Questionnaire (MEQ) to estimate the timing of their circadian clocks, including ideal sleep and wake-up times. |
Week 6
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jonathan W Stewart, MD, New York State Psychiatric Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7361 (IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
- CSR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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