Seasonal Affective DisorderPhase 2NCT00016666
Clinical Trial of Propranolol for Seasonal Affective Disorder
A Phase 2 study testing Propranolol in people with Seasonal Affective Disorder and Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Affective Disorder, Healthy
- What is being tested?
- Propranolol
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2001to 19 Jan 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Winter Depression With Pharmacological Suppression of Melatonin Secretion
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.
Read more
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.
Read the detailed description
Symptoms of seasonal affective disorder (SAD) in humans resemble seasonal changes that occur in animals. Moreover, in both humans and animals, the occurrence of these changes is regulated by light. In animals the circadian pacemaker regulates seasonal behavior by transmitting a signal of daylength to other sites in the organism. This signal is expressed, reciprocally, in the duration of nocturnal melatonin secretion, which is longer in winter and shorter in summer. Sites distal to the pineal that regulate seasonal behavior read and respond to this melatonin signal of change of season. In a longitudinal study, we showed that a homologous melatonin signal of change of season is present in patients with SAD but not in healthy volunteers. In light of the animal models, this finding raises the possibility that seasonal changes in duration of melatonin secretion govern the course of illness in patients with SAD. If so, then an intervention that shortens the duration of melatonin secretion in winter and thereby mimics the effect of summer days should improve symptoms of winter depression. To test this hypothesis, we propose to administer propranolol, a beta-adrenergic receptor blocking medication that is frequently prescribed for the treatment of hypertension, to patients with SAD in the winter. We will administer propranolol at a time of night when it would suppress and shorten the duration of melatonin secretion and then ascertain whether this intervention improves depression. A unique feature of this parallel-design, controlled clinical trial is that propranolol, when administered at a time of day when melatonin is not secreted, can serve as its own active placebo.
- Conditions
- Seasonal Affective Disorder, Healthy
- Being tested
- Propranolol
- Keywords
- Season, Light, Propranolol, Photoperiod, Pharmacokinetics, Circadian Rhythm, Seasonal Rhythm, Seasonal Affective Disorder, Pineal Gland, Suprachiasmatic Nucleus, Healthy Volunteer, HV, Winter Depression, SAD
- Medical subject headings
- Seasonal Affective Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2001 (estimated)
- Study start21 May 2001
- Study completion19 Jan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal Affective DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016666
- Sponsor's protocol ID
- 010175
- Other IDs
- 01-M-0175
- Status last verified
- 19 Jan 2007
- First submitted
- 23 May 2001
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 3998065
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Winter Depression With Pharmacological Suppression of Melatonin Secretion
- ClinicalTrials.gov ID
- NCT00016666
- Acronym / sponsor ID
- 010175
- Conditions
- Seasonal Affective Disorder, Healthy
- Keywords
- Season, Light, Propranolol, Photoperiod, Pharmacokinetics, Circadian Rhythm, Seasonal Rhythm, Seasonal Affective Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 21 May 2001
- Study completion
- 19 Jan 2007
- First posted
- 24 May 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Symptoms of seasonal affective disorder (SAD) in humans resemble seasonal changes that occur in animals. Moreover, in both humans and animals, the occurrence of these changes is regulated by light. In animals the circadian pacemaker regulates seasonal behavior by transmitting a signal of daylength to other sites in the organism. This signal is expressed, reciprocally, in the duration of nocturnal melatonin secretion, which is longer in winter and shorter in summer. Sites distal to the pineal that regulate seasonal behavior read and respond to this melatonin signal of change of season. In a longitudinal study, we showed that a homologous melatonin signal of change of season is present in patients with SAD but not in healthy volunteers. In light of the animal models, this finding raises the possibility that seasonal changes in duration of melatonin secretion govern the course of illness in patients with SAD. If so, then an intervention that shortens the duration of melatonin secretion in winter and thereby mimics the effect of summer days should improve symptoms of winter depression. To test this hypothesis, we propose to administer propranolol, a beta-adrenergic receptor blocking medication that is frequently prescribed for the treatment of hypertension, to patients with SAD in the winter. We will administer propranolol at a time of night when it would suppress and shorten the duration of melatonin secretion and then ascertain whether this intervention improves depression. A unique feature of this parallel-design, controlled clinical trial is that propranolol, when administered at a time of day when melatonin is not secreted, can serve as its own active placebo.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propranolol | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 3998065Arendt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol in people with Seasonal Affective Disorder and Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00016666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.