Clinical Trials of Three Non-Drug Treatments for Winter Depression (SAD)

Light and Ion Therapy for Seasonal Affective Disorder

Lead Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Mental Health (NIMH)

Source

New York State Psychiatric Institute

Oversight Info

Has Dmc

Brief 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.

Overall Status

Completed

Start Date

1998-09-01

Completion Date

2004-04-01

Primary Completion Date

2003-06-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure	Time Frame
Depression scale score	3 weeks

Secondary Outcome

Measure	Time Frame
time of pineal melatonin onset	3 weeks

Enrollment

150

Conditions

Seasonal Affective Disorder

, Mood Disorders

, Depression

dawn light pulse

Eligibility

Criteria

Inclusion Criteria: - Diagnosis of major depression or bipolar disorder, with regular onset of depression in fall or winter and remission in spring - Able to maintain a regular sleep schedule Exclusion Criteria: - Presence of psychiatric disorders other than major depression or bipolar depression - 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

Gender

All

Minimum Age

18 Years

Maximum Age

70 Years

Healthy Volunteers

Overall Official

Last Name	Role	Affiliation
Michael Terman	Principal Investigator	Columbia University

Location

Facility

Columbia Presbyterian Medical Center
New York New York 10032 United States

Location Countries

Country

United States

Verification Date

2005-11-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor

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

Has Expanded Access

Condition Browse

Disease

, Depression

, Depressive Disorder

, Mood Disorders

N/A

Reference

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Single (Outcomes Assessor)

Study First Submitted

November 22, 2000

Study First Submitted Qc

November 22, 2000

Study First Posted

November 23, 2000

Last Update Submitted

June 2, 2015

Last Update Submitted Qc

June 2, 2015

Last Update Posted

June 3, 2015

ClinicalTrials.gov processed this data on December 13, 2019

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.

Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.

Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.

ICH GCP | Clinical Trials Registry

Light and Ion Therapy for Seasonal Affective Disorder