Impact of Hot Flashes on Sleep and Mood Disturbance

Depression Clinical Trial

Official title:

Impact of Experimentally Induced Hot Flashes on Sleep and Mood Disturbance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116401
• Other study ID #: 2009-P-001557
• Secondary ID: 5R01MH082922
• Status: Completed
• Phase: Phase 4
• First received: May 3, 2010
• Last updated: December 26, 2017
• Start date: November 3, 2009
• Est. completion date: January 4, 2012

Study information

• Verified date: December 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We plan to enroll premenopausal women in a trial investigating the impact of hot flashes developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa), leuprolide (brand name: Lupron), on sleep disruption and mood. This study is designed to mimic the menopause transition. We will collect data on sleep disruption and mood changes to assess their relationship to the development of hot flashes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 4, 2012
• Est. primary completion date: December 29, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women 18-45 years old

• Premenopausal

• Willingness to use barrier methods of contraception during study and after completion of study until menses resume

• Good general health

Exclusion Criteria:

• Pregnancy or currently breastfeeding

• Hot flushes

• Mid-luteal phase progesterone <3ng/mL

• Clinically significant abnormalities in screening blood tests

• BMI > 35 kg/m2

• Previously diagnosed osteoporosis or osteopenia

• Clinically significant depressive symptoms

• Psychiatric illness

• Sleep apnea or periodic limb movement of sleep (PLMS)

• Contraindication, hypersensitivity, or previous allergic reaction to GnRH agonists

• Current or recent use of centrally active medications

• Current or recent use of systemic hormone medications

• Night shift workers

• Current use of over-the-counter (OTC) medications that may affect hot flashes, sleep, or mood

• Abnormal vaginal bleeding

• History of any medical diseases that may put subject at risk when treated with study medication.

Related Conditions & MeSH terms

• Depression
• Hot Flashes
• Menopause

Intervention

Drug:
• leuprolide
Leuprolide acetate is a widely used GnRH agonist. In this protocol, leuprolide will be administered at a dose routinely used for treatment of endometriosis and uterine fibroids in women (one 3.75-mg intramuscular injection).

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Wake After Sleep Onset (WASO)	Wake after sleep onset (WASO) is calculated by averaging the number of minutes spent awake after initiating sleep each night from the two ambulatory polysomnography studies conducted at baseline and the two ambulatory polysomnography studies conducted four weeks after the GnRHa injection.	baseline and 4 weeks
Secondary	Change in Montgomery-Asperg Depression Rating Scale (MADRS)	The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and four weeks after the GnRHa injection in order to calculate the change in MADRS score.	baseline and 4 weeks