Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00001485
Other study ID # 950149
Secondary ID 95-M-0149
Status Completed
Phase N/A
First received November 3, 1999
Last updated March 3, 2008
Start date June 1995
Est. completion date April 2000

Study information

Verified date August 1999
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

As the seasons change during the course of the year, many animals show major changes in their behavior and physiology. Many of these changes are triggered by changes in the length of time each night that the pineal gland produces the hormone melatonin. Melatonin is produced for a longer time in winter when nights are long, than in summer when nights are short.

Some researchers believe that melatonin may play a similar role in how season effects mood of patients with seasonal affective disorder. Seasonal affective disorder (SAD) or mood disorder with seasonal pattern is a condition where the normal biorhythm is disturbed during a season, especially autumn-winter. Patients may begin experiencing or experience worsening of depressive symptoms. Patients complain of being constantly tired, craving sugary foods, overeating, and over sleeping.

Researchers have collected some preliminary data showing that the duration of nighttime melatonin secretion increases in winter and decreases in summer in healthy women, but not in healthy men. However, men diagnosed with SAD have shown longer duration of melatonin secretion in the winter, similar to the duration seen in healthy women. If these early findings are confirmed it may explain why SAD is more common in women than in men.

The purpose of this study is to continue researching the differences in melatonin secretion over the seasons in healthy men and women, and to determine how these findings may apply to patients with SAD.


Description:

Changes in the duration of nocturnal melatonin secretion that are induced by seasonal changes in the length of the night trigger many of the dramatic seasonal changes in behavior that occur in animals. It has been hypothesized that melatonin plays a similar role as chemical mediator of the effects of season on mood in patients with seasonal affective disorder (SAD). For such a hypothesis to be tenable, it would be necessary to show that duration of nocturnal melatonin secretion changes on a seasonal basis in patients with SAD. We have preliminary evidence that the duration (and amplitude) of nocturnal melatonin secretion increases in winter and decreases in summer in healthy women, but not in healthy men. This gender difference, if confirmed, might explain why SAD is more prevalent in women than men. Interestingly, all of five men with SAD that we have studied to date exhibited lengthening of melatonin secretion in winter, as occurs in healthy women. However, the response of women with SAD is less consistent. The purpose of the present protocol is to extend and confirm our finding of gender differences in the response of melatonin secretion to change of season in healthy individuals, and to determine whether and to what extent this response occurs in patients with SAD.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date April 2000
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Normal volunteers must be free of psychiatric illnesses.

Patients must meet the criteria of Rosenthal et al. for the diagnosis of SAD, as determined by a DSM IV diagnostic interview, and must be free of other major psychiatric illnesses.

All subjects must be free of major medical illnesses and must not be taking medications on a regular basis.

Patients must not test positive for antibodies to the AIDS virus.

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institute of Mental Health (NIMH) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Wehr TA, Moul DE, Barbato G, Giesen HA, Seidel JA, Barker C, Bender C. Conservation of photoperiod-responsive mechanisms in humans. Am J Physiol. 1993 Oct;265(4 Pt 2):R846-57. — View Citation

Wehr TA. The durations of human melatonin secretion and sleep respond to changes in daylength (photoperiod). J Clin Endocrinol Metab. 1991 Dec;73(6):1276-80. — View Citation

See also
  Status Clinical Trial Phase
Completed NCT00502320 - Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder Phase 4
Completed NCT00046241 - Prevention of Seasonal Affective Disorder Phase 3
Completed NCT00006517 - Clinical Trials of Three Non-Drug Treatments for Winter Depression (SAD) N/A
Active, not recruiting NCT03691792 - Optimizing Long-Term Outcomes for Winter Depression With CBT-SAD and Light Therapy N/A
Completed NCT01462058 - The Role of Vitamin D Supplementation on Well Being and Symptoms of Depression During the Winter Season in Health Service Staff Phase 4
Recruiting NCT01030276 - Bright Light Therapy in Seasonal Affective Disorder (SAD) N/A
Completed NCT01292889 - Study of Genes in Relation to Seasonal Affective Disorder and Major Depressive Disorder N/A
Completed NCT01149135 - Low Intensity 'Blue Light' Treatment of Seasonal Affective Disorder N/A
Completed NCT01048294 - Blue Enriched Versus Standard Light Treatment for Seasonal Affective Disorder(SAD) N/A
Completed NCT02582398 - Influence of Light Exposure on Cerebral MAO-A in Seasonal Affective Disorder and Healthy Controls Measured by PET N/A
Completed NCT01293409 - Bright Light Therapy in Seasonal Affective Disorder (SAD) N/A
Active, not recruiting NCT00269633 - Research Study of Treatment for Winter Depression With Different Colors of Light Phase 2
Completed NCT00076245 - Cognitive Behavioral Therapy for the Treatment of Seasonal Affective Disorder (SAD) Phase 1
Completed NCT03313674 - Investigation of Seasonal Variations of Brain Structure and Connectivity in SAD N/A
Completed NCT00016666 - Clinical Trial of Propranolol for Seasonal Affective Disorder Phase 2
Recruiting NCT00114322 - Light-Emitting Diode (LED) Light for Seasonal Affective Disorder (SAD) Treatment N/A
Completed NCT01462305 - 30-Minute Light Exposure for the Treatment of Seasonal Affective Disorder N/A
Completed NCT00139997 - Environmental Treatment for Seasonal Affective Disorder (SAD) N/A
Completed NCT04251000 - Infrared Photomodulation Therapy for Seasonal Affective Disorder N/A
Completed NCT00809523 - A Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD) Phase 2/Phase 3