Are Bright Lights and Regulated Sleep Effective Treatment for Depression?
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/31/2018 |
| Start Date: | November 2016 |
| End Date: | November 2021 |
| Contact: | Peter C Arden, BA |
| Email: | ArdenPe@nyspi.columbia.edu |
| Phone: | 646-774-8004 |
Are Bright Lights and Regulated Sleep Effective Treatment for Depression.
Previous data suggest some depressed patients act as if their internal biological clock is
out of sync with the outside world and re-aligning their clock with the timing of sunlight
lessens their depressed mood and accompanying depressive symptoms. This "chronotherapy" may
produce remission during the first week of treatment while causing minimal problems. This
study aims to demonstrate the efficacy of chronotherapy by comparing two protocols for
inducing sleep phase advance. Which chronotherapy condition a participant will receive will
be determined randomly (i.e., by chance, essentially a computerized flip of a coin). Prior to
determination of which protocol a patient will follow, each patient will declare their
desired sleep time (for example, 11 p.m. to 7 a.m.). All patients will be assigned specific
times to sleep and sit in front of bight lights wearing clear or amber goggles. Assigned
sleep times will differ between groups using different strategies to shift the timing of
their sleep from their ideal sleep time as determined by their Morningness-Eveningness
Questionnaire (MEQ) score to their desired sleep time. All participants will be rated daily
by telephone for the first week following randomization, and then weekly for an additional
five weeks. Whenever possible, weekly visits will be in person, although telephone visits
will be allowed. All participants will be rated at baseline, 1 week and 6 weeks by an
Independent Evaluator blind to treatment assignment (as well as the nature of the treatment
and if it has occurred or not). After the six week post-randomization evaluation, all
participants will be offered six months of continued treatment and be rated monthly.
Treatment during this six month period may consist of Chronotherapy or conventional
antidepressants as the patient and doctor determine. Standard ratings of depression, over-all
illness and functioning will be obtained. Change in the symptom measures will determine
treatment efficacy. Analysis of saliva melatonin levels, sleep logs and activity monitor data
will measure the timing of the biological clock and whether it has been shifted by the
treatment. Measures of functioning will determine whether functioning improves coincident
with, independent of, or subsequent to mood improvement.
out of sync with the outside world and re-aligning their clock with the timing of sunlight
lessens their depressed mood and accompanying depressive symptoms. This "chronotherapy" may
produce remission during the first week of treatment while causing minimal problems. This
study aims to demonstrate the efficacy of chronotherapy by comparing two protocols for
inducing sleep phase advance. Which chronotherapy condition a participant will receive will
be determined randomly (i.e., by chance, essentially a computerized flip of a coin). Prior to
determination of which protocol a patient will follow, each patient will declare their
desired sleep time (for example, 11 p.m. to 7 a.m.). All patients will be assigned specific
times to sleep and sit in front of bight lights wearing clear or amber goggles. Assigned
sleep times will differ between groups using different strategies to shift the timing of
their sleep from their ideal sleep time as determined by their Morningness-Eveningness
Questionnaire (MEQ) score to their desired sleep time. All participants will be rated daily
by telephone for the first week following randomization, and then weekly for an additional
five weeks. Whenever possible, weekly visits will be in person, although telephone visits
will be allowed. All participants will be rated at baseline, 1 week and 6 weeks by an
Independent Evaluator blind to treatment assignment (as well as the nature of the treatment
and if it has occurred or not). After the six week post-randomization evaluation, all
participants will be offered six months of continued treatment and be rated monthly.
Treatment during this six month period may consist of Chronotherapy or conventional
antidepressants as the patient and doctor determine. Standard ratings of depression, over-all
illness and functioning will be obtained. Change in the symptom measures will determine
treatment efficacy. Analysis of saliva melatonin levels, sleep logs and activity monitor data
will measure the timing of the biological clock and whether it has been shifted by the
treatment. Measures of functioning will determine whether functioning improves coincident
with, independent of, or subsequent to mood improvement.
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.
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.
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
We found this trial at
1
site
New York, New York 10032
Principal Investigator: Jonathan W. Stewart, M.D.
Phone: 646-774-8070
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