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Clinical trials of three non-drug treatments for winter depression (SAD). Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Clinical trials of three non-drug treatments for winter depression (SAD). conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Clinical trials of three non-drug treatments for winter depression (SAD). Clinical research trials and Clinical trials of three non-drug treatments for winter depression (SAD). health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Clinical trials of three non-drug treatments for winter depression (SAD).. Clinical trials of three non-drug treatments for winter depression (SAD). Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Clinical trials of three non-drug treatments for winter depression (SAD). clinical trial. Human subjects frequently get the finest healthcare available for their Clinical trials of three non-drug treatments for winter depression (SAD). condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Clinical trials of three non-drug treatments for winter depression (SAD).  Clinical trials of three non-drug treatments for winter depression (SAD).
Clinical trials of three non-drug treatments for winter depression (SAD).
For Condition: Depressive Disorders,Seasonal Affective Disorder,Mood Disorders
Status: Completed
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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.
Details: 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 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Single Blind
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Male or female ages 18-70 with a diagnosis of major depression or bipolar disorder, with regular onset of depression in fall or winter and remission in spring. Must be able to maintain a regular sleep schedule. Exclusion Criteria: - Presence of other psychiatric disorders. Current use of antidepressant or recreational drugs, or psychotropic medication or supplements that may affect mood. Current medical illness or medication that might interfere with response to treatment. Long-distance travel during the program.
Total Enrollment: 500
Location and Contact Information:
Overall Study Official:
MichaelTerman, Principal Investigator, Columbia Presbyterian Medical Center
Columbia Presbyterian Medical Center
New York City, New York, 10032
United States
Additional Information:
Study ID Numbers: MH42931; 5 RO1 MH42931
Study Start Date: September 1998
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006517
Other Mood Disorders Studies:
1. The Study of Olanzapine Plus Fluoxetine in Combination for Treatment-Resistant Depression Without Psychotic Features
2. Clinical trials of three non-drug treatments for winter depression (SAD).
3. Clinical trials of two non-drug treatments for chronic depression
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Clinical trials of three non-drug treatments for winter depression (SAD).
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