|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 11, 2000 | ||||
| Last Updated Date | March 4, 2008 | ||||
| Start Date ICMJE | April 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00006172 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Clinical Trials of Two Non-Drug Treatments for Chronic Depression | ||||
| Official Title ICMJE | Light and Negative Ion Treatment for Chronic Depression | ||||
| 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 person's 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 Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups | |||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | June 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00006172 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R01 MH42931-02, DSIR AT-SO | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | March 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||