Clinical Trials of Three Non-Drug Treatments for Winter Depression (SAD)
Condition: Seasonal Affective Disorder; Mood Disorders; Depression
MeSH terms: Depression; Depressive Disorder; Mood Disorders; Seasonal Affective Disorder
Study type: Interventional

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 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.
    

Intervention name(s): bright light box; dawn simulator; high-output negative ion generator; low-output negative ion generator; dawn light pulse
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): 10,000 lux bright light therapy; gradual rise in bedroom illumination prior to wake-up; automated air ion delivery in bedroom prior to wake-up; automated air ion delivery in bedroom prior to wake-up; rectangular light pulse matched for lux.time of dawn simulation delivered prior towake-up
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Seasonal Affective Disorder (SAD); Winter Depression; Mood disorders; Bipolar I and II disorders; Major Depressive Disorder, Recurrent; Light therapy; Phototherapy; Dawn Simulation therapy; Negative air ionization therapy; Chronobiology; Biological rhythms