Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006517
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2000-11-22
Brief Title:
Clinical Trials of Three Non-Drug Treatments for Winter Depression SAD
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Light and Ion Therapy for Seasonal Affective Disorder
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We are offering non-pharmacologic therapy for alleviation of symptoms associated with depressed mood that recurs annually in fall or winter The treatments are self-administered at home by the patient with close clinical supervision Our trials use specially designed devices that replenish two different environmental elements naturally occurring light and negative ions in the air Both factors may be reduced in winter bringing on depression
Detailed Description:
The treatments we are investigating include bright light therapy upon awakening and two contrasting treatments during the final hours of sleep negative air ionization provided at two levels and dawn simulation also at two levels both switched on by a silent electronic timer or microprocessor We hypothesize that the reduced outdoor light availability in winter as well as reduced concentration of negative ions in the air circulation are both factors that contribute to depression By supplementing the indoor environment with either ions or light we are aiming to recreate summer-like conditions that are therapeutic Our past studies have shown all three methods to have antidepressant effects in patients with seasonal affective disorder SAD Unlike light therapy negative air ionization is imperceptible you cannot sense when the ionizer is active
Applications to the program are accepted and reviewed throughout the year Screening interviews for entry into the program are scheduled between August and February Patients and researchers both benefit most when applications are received by the start of the individuals problem season because this leaves maximum time to explore alternate treatments Candidates undergo a two-hour personal interview at Columbia-Presbyterian Medical Center that ascertains whether they meet inclusion criteria At a second two-hour visit we provide a standard medical examination including blood tests urinalysis and EKG all without cost As an alternative physicals may be performed by ones personal physician Once the study is underway there are about five additional one-hour appointments for clinical evaluations flexibly scheduled during the business day usually about 10 days apart
We provide the treatment apparatus on loan All treatments are scheduled in the morning around the time of awakening The bedroom treatments negative ions or dawn simulation end by the time of awakening The bright light treatment takes place for half an hour after waking up Initially patients are randomly assigned to one of the treatment groups The treatment must be taken consistently for three weeks at the same time every day after which it is temporarily suspended to determine whether symptoms return Given sufficient time within the winter season patients then have the opportunity to try one of the alternate treatments to determine which works best for them This provides an informed confident basis for a treatment plan for subsequent years
As part of the protocol patients provide saliva samples on two evenings which are used to test for the level of melatonin a hormone that becomes active at night Results reveal whether a persons internal circadian rhythm is early late or normal information that can be used to guide the timing of future treatment This constitutes a distinct benefit for research participants since such a diagnostic test is not yet available in medical practice
Applications to the program are accepted and reviewed throughout the year Screening interviews for entry into the program are scheduled between August and February Patients and researchers both benefit most when applications are received by the start of the individuals problem season because this leaves maximum time to explore alternate treatments Candidates undergo a two-hour personal interview at Columbia-Presbyterian Medical Center that ascertains whether they meet inclusion criteria At a second two-hour visit we provide a standard medical examination including blood tests urinalysis and EKG all without cost As an alternative physicals may be performed by ones personal physician Once the study is underway there are about five additional one-hour appointments for clinical evaluations flexibly scheduled during the business day usually about 10 days apart
We provide the treatment apparatus on loan All treatments are scheduled in the morning around the time of awakening The bedroom treatments negative ions or dawn simulation end by the time of awakening The bright light treatment takes place for half an hour after waking up Initially patients are randomly assigned to one of the treatment groups The treatment must be taken consistently for three weeks at the same time every day after which it is temporarily suspended to determine whether symptoms return Given sufficient time within the winter season patients then have the opportunity to try one of the alternate treatments to determine which works best for them This provides an informed confident basis for a treatment plan for subsequent years
As part of the protocol patients provide saliva samples on two evenings which are used to test for the level of melatonin a hormone that becomes active at night Results reveal whether a persons internal circadian rhythm is early late or normal information that can be used to guide the timing of future treatment This constitutes a distinct benefit for research participants since such a diagnostic test is not yet available in medical practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH042931-01 | NIH | None | httpsreporternihgovquickSearchR01MH042931-01 |