Clinical Trial of Propranolol for Seasonal Affective Disorder

NCT00016666 | Completed Phase 2

• 2 other identifiers: 01017501-M-0175
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine what dose of a new timed-release tablet of the drug propranolol will reduce secretion of the hormone melatonin in healthy volunteers. This study will also determine whether suppressing melatonin will improve depressive symptoms in people with seasonal affective disorder (SAD). SAD (sometimes referred to as winter depression) is a condition in which people experience depression as a result of seasonal variations in light. Human brains have a circadian pacemaker that regulates many body functions. As the seasons change and light duration varies, the circadian pacemaker regulates seasonal behavior by transmitting a signal of day length to the pineal gland, which secretes the hormone melatonin. Melatonin secretion increases in the winter as the duration of light decreases. Evidence suggests that the melatonin signal of seasonal change is present in people with SAD but not in healthy volunteers; thus there is a possibility that seasonal changes which influence the duration of melatonin secretion control the course of illness in individuals with SAD. This study will determine whether propranolol can shorten the duration of melatonin secretion and mimic the effect of summer days to improve symptoms of depression in people with SAD. Healthy volunteers will be admitted to the hospital for about 2 days. The volunteers will receive either propranolol or placebo (an inactive pill) before going to bed and upon awakening. Blood samples will be collected at various times throughout the study. Participants with SAD will be interviewed periodically on an outpatient basis to determine the onset of depression in the fall or winter. Two weeks after depressive symptoms arise, participants will begin treatment with either propranolol or placebo. At the beginning of the treatment, participants will be hospitalized for about 2 days and will have blood collected at various times. During the hospital stay, participants will continue treatment with either propranolol or placebo in the morning and at night; all participants will receive propranolol at some point during the study. Participants will be interviewed weekly for 4 weeks. Premenopausal women with or without SAD will keep a record of their menstrual cycles and will use a urine test kit to identify the time of ovulation during the month before and after admission to the hospital.

Conditions

Seasonal Affective Disorder; Healthy

Keywords

Season; Light; Propranolol; Photoperiod; Pharmacokinetics; Circadian Rhythm; Seasonal Rhythm; Seasonal Affective Disorder; Pineal Gland; Suprachiasmatic Nucleus; Healthy Volunteer; HV; Winter Depression; SAD

Interventions

Propranolol DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and non-pregnant women non-smokers of all ethnic backgrounds between the ages of 18 to 50 who are free of major medical illness and who agree and are medically able to abstain from alcohol and all drugs, to adhere to a regular sleep schedule, and to limit caffeine-intake to less than or equal to 2 cups of coffee per day for at least two weeks (prescription drugs, 4 weeks) before, and for 4 weeks during the treatment period are eligible to participate.
• Healthy volunteers will also be free of major psychiatric illness.
• Patients will meet the criteria of Rosenthal et al. (1982) for Seasonal Affective Disorder.

You may not qualify if:

• Patients will be ineligible for participation if they are currently being treated with an antidepressant drug.
• Women who are pregnant or breast feeding will not participate.
• Individuals who have a major medical illness or who are unable to abstain from nicotine, alcohol and all drugs for at least two weeks (prescription drugs 4 weeks) and to limit caffeine-intake to less than or equal to 2 cups per day of coffee before the study and during the study will not participate.
• Individuals with cardiac valve disease will be excluded.
• Individuals with histories of these illnesses or conditions will specifically be excluded from participating: asthma, bronchospastic disease, obstructive pulmonary disease, coronary artery disease, congestive heart failure, A-V block, peripheral vascular disease, diabetes, thyrotoxicosis, severe allergic reactions, and sinus bradycardia.
• Subjects older than 50 will be excluded.
• Patients who report that they have been previously treated with a beta adrenergic receptor antagonist will be excluded.
• Individuals who have unusual or irregular sleep schedules or who work on shifts will be excluded from participating.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

Harvard University

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Arendt J, Bojkowski C, Franey C, Wright J, Marks V. Immunoassay of 6-hydroxymelatonin sulfate in human plasma and urine: abolition of the urinary 24-hour rhythm with atenolol. J Clin Endocrinol Metab. 1985 Jun;60(6):1166-73. doi: 10.1210/jcem-60-6-1166.

  PMID: 3998065 BACKGROUND

MeSH Terms

Conditions

Seasonal Affective Disorder

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 23, 2001
• First Posted: May 24, 2001
• Study Start: May 21, 2001
• Study Completion: January 19, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-01-19

Locations

US (1)