Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006172
Status:
COMPLETED
Last Update Posted:
2014-10-01
First Post:
2000-08-11
Brief Title:
Clinical Trials of Two Non-drug Treatments for Chronic Depression
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Light and Negative Ion Treatment for Chronic Depression
Status:
COMPLETED
Status Verified Date:
2008-03
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:
This study investigates the potential efficacy of two nonpharmacologic treatments for nonseasonal depression bright light exposure or high-density negative air ion exposure Treatments are self-administered at home by the patient under close clinical supervision
Detailed Description:
Bright light exposure and high-density negative ion exposure have been designed to mimic outdoor environmental conditions and are effective in relieving symptoms of seasonal winter depression but their effectiveness in treating chronic depression has not been explored
Participants in this 10-week study will have an interview a complete physical exam and six one-hour appointments for progress evaluations They will be randomly assigned to either light or high- or low-dose negative ions Each treatment must be taken consistently for five weeks at the same time every day after which treatment is temporarily suspended to determine whether symptoms return Participants will then have the opportunity to try the alternate active treatment to determine which works best for them On two occasions participants will provide saliva samples used to determine the level of melatonin a hormone that becomes active at night and indicates whether a persons internal circadian clock is in sync with the day-night cycle or is early or late This diagnostic test for melatonin which is not yet readily available in medical practice provides our research participants with unique information that can be used to optimize the timing of future treatment
Participants in this 10-week study will have an interview a complete physical exam and six one-hour appointments for progress evaluations They will be randomly assigned to either light or high- or low-dose negative ions Each treatment must be taken consistently for five weeks at the same time every day after which treatment is temporarily suspended to determine whether symptoms return Participants will then have the opportunity to try the alternate active treatment to determine which works best for them On two occasions participants will provide saliva samples used to determine the level of melatonin a hormone that becomes active at night and indicates whether a persons internal circadian clock is in sync with the day-night cycle or is early or late This diagnostic test for melatonin which is not yet readily available in medical practice provides our research participants with unique information that can be used to optimize the timing of future treatment
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 |
|---|---|---|---|
| R01MH042931-02 | NIH | None | httpsreporternihgovquickSearchR01MH042931-02 |