Clinical Trials of Three Non-Drug Treatments for Winter Depression (SAD)
|First Received Date ICMJE||November 22, 2000|
|Last Updated Date||February 3, 2009|
|Start Date ICMJE||September 1998|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00006517 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Clinical Trials of Three Non-Drug Treatments for Winter Depression (SAD)|
|Official Title ICMJE||Light and Ion Therapy for Seasonal Affective Disorder|
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.
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 individual's "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 one's 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 person's 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 Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Masking: Single Blind
Primary Purpose: Treatment
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||June 2003|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 70 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00006517|
|Other Study ID Numbers ICMJE||R01 MH42931-01, DSIR AT-SO|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Mental Health (NIMH)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institute of Mental Health (NIMH)|
|Verification Date||November 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP