Study of PET Scans and Serotonin in Hot Flashes Treatment
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Purpose
The purpose of this study is to determine in a preliminary manner whether successful therapy of hot flashes can be associated with changes in the serotonin transporter in the brain. The serotonin transporter is important in delivering serotonin into certain portions of the brains (serotonin is a chemical that is important in the control of body temperature, mood, sleep, and other functions).
| Condition | Intervention |
|---|---|
|
Hot Flashes |
Drug: Paroxetine controlled-release Drug: Conjugated equine estrogen |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Feasibility Study of Positron Emission Tomography (PET) of the Serotonin Transporter (SERT) Before and After Treatment With Conjugated Equine Estrogen or Paroxetine for Hot Flashes |
- To estimate the proportion of women who have a 50% or greater reduction in frequency of hot flashes following 4 weeks of paroxetine or conjugated equine estrogen. [ Time Frame: Following 4 weeks of study medication ] [ Designated as safety issue: No ]
- To evaluate baseline and change in binding of the serotonin transporter in postmenopausal women who suffer hot flashes before and after 4 weeks of paroxetine or conjugated equine estrogen using PET. [ Time Frame: Following 4 weeks of study medication ] [ Designated as safety issue: No ]
- To correlate baseline and change in binding of the serotonin transporter using PET with reduction of hot flashes after 4 weeks of conjugated equine estrogen or paroxetine. [ Time Frame: Following 4 weeks of study medication ] [ Designated as safety issue: No ]
| Enrollment: | 5 |
| Study Start Date: | October 2005 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Paroxetine
Paroxetine controlled-release (2-12.5 mg tablets, orally, every day for 4 weeks)
|
Drug: Paroxetine controlled-release
2-12.5 mg tablets, orally, every day for 4 weeks
Other Name: Paxil CR
|
|
Experimental: Conjugated equine estrogen
Conjugated equine estrogen (0.625 mg tablet, orally, every day for 4 weeks)
|
Drug: Conjugated equine estrogen
0.625 mg tablet, orally, every day for 4 weeks
Other Name: Premarin
|
Detailed Description:
Hot flashes represent the most common complaint among peri- and postmenopausal women. Over 60% of postmenopausal women experience hot flashes, and 10-20% of all postmenopausal women find them nearly intolerable. Despite the prevalence of hot flashes, their pathophysiology is not well understood. Treatment options include non-pharmacological approaches, hormonal interventions, and non-hormonal pharmacological agents. The most effective treatment for hot flashes is estrogen. The most promising non-hormonal treatments for hot flashes are selective serotonin or noradrenergic reuptake inhibitors (SSRI/SNRI). Although estrogen withdrawal is implicated in the initiation of hot flashes, and serotonin's role is well established in thermoregulation, the relationship between estrogen and serotonin is not known. Preclinical studies suggest that both estrogen and SSRI down regulate the serotonin transporter. Clinical studies that further delineate the relationship between effective treatments for hot flashes and the serotonin transporter may shed a new light into the pathophysiology of these symptoms and more importantly, into design of new-targeted treatments.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Postmenopausal women
- 7 or more hot flashes per day for at least 3 months
- Must be able to undergo magnetic resonance (MR) and PET imaging
- Must be able to receive either paroxetine or estrogen
Exclusion Criteria:
- No treatment with hormone therapy or other medications that affect estrogen within the past 3 months
- No evidence of a currently active cancer
Contacts and Locations| United States, Maryland | |
| Johns Hopkins University School of Medicine | |
| Baltimore, Maryland, United States, 21231 | |
| Principal Investigator: | Vered Stearns, MD | Johns Hopkins University |
More Information
No publications provided
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00249847 History of Changes |
| Other Study ID Numbers: | SKCCC J0360 |
| Study First Received: | November 4, 2005 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
Hot flashes, vasomotor symptoms, estrogen, paroxetine |
Additional relevant MeSH terms:
|
Hot Flashes Signs and Symptoms Estrogens Estrogens, Conjugated (USP) Serotonin Paroxetine Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Serotonin Receptor Agonists |
Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013