Completed

Gender Differences in the Effects of Season on Patterns of Nocturnal Melatonin Secretion in Healthy Volunteers and Patients With Seasonal Affective Disorder (SAD)

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What is being collected

Data Collection

Who is being recruted

Mental Disorders+1

+ Depressive Disorder

+ Mood Disorders

See all eligibility criteria
How is the trial designed

Observational
Study Start: June 1995
See protocol details

Summary

Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 1995

Actual date on which the first participant was enrolled.

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.

NCT00001485
Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

116 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersDepressive DisorderMood DisordersSeasonal Affective Disorder

Criteria

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 Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institute of Mental Health (NIMH)

Bethesda, United StatesOpen National Institute of Mental Health (NIMH) in Google Maps
CompletedOne Study Center