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NCT00016666 · ClinicalTrials.gov registry record · Phase 2
Clinical Trial of Propranolol for Seasonal Affective Disorder
A Phase 2 study of Healthy and Seasonal Affective Disorder, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT00016666: Completed Phase 2 study of Healthy and Seasonal Affective Disorder, sponsored by National Institute of Mental Health (NIMH).
NCT00016666 is a Phase 2 study of Healthy and Seasonal Affective Disorder that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 70 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00016666, a Phase 2 study of Healthy and Seasonal Affective Disorder, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- DRUG Propranolol
Study Locations (1)
Massachusetts
- Harvard University - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2001-05-21 |
| Est. Completion | 2007-01-19 |
| Phase | Phase 2 |
What the finished NCT00016666 record still lists
NCT00016666 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Propranolol is the first listed.
NCT00016666 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00016666 about?
NCT00016666 is a clinical study titled "Clinical Trial of Propranolol for Seasonal Affective Disorder". 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 affect...
What is the current status of trial NCT00016666?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2001-05-21. Estimated completion is 2007-01-19.
What conditions does trial NCT00016666 study?
This clinical trial studies the following conditions: Healthy, Seasonal Affective Disorder.
What interventions are being tested in trial NCT00016666?
The interventions under investigation include: Propranolol (DRUG).
Who is sponsoring clinical trial NCT00016666?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00016666 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00016666's enrollment target sits among peer trials
70 325th of 1090 higher than 759 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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