NCT00001485

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 1995

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1995

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2000

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

August 1, 1999

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

Chemical MediatorsCircadian RhythmsGender DifferencesMelatoninPhotoperiodismSeasonal Changes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • 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. doi: 10.1210/jcem-73-6-1276.

    PMID: 1955509BACKGROUND
  • 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. doi: 10.1152/ajpregu.1993.265.4.R846.

    PMID: 8238456BACKGROUND

MeSH Terms

Conditions

Seasonal Affective Disorder

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

June 1, 1995

Study Completion

April 1, 2000

Last Updated

March 4, 2008

Record last verified: 1999-08

Locations