Affect of Duavive on Mood & Anxiety Symptoms

Sleep Clinical Trial

— DOMA  

Official title:

The Effect of Conjugated Estrogens/ Bazedoxifene (CE/ BZA) on Peri- and Postmenopausal Mood and Anxiety Symptoms: A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04478305
• Other study ID #: 2019-7333
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 2021
• Est. completion date: September 2021

Study information

• Verified date: October 2020
• Source: St. Joseph's Healthcare Hamilton
• Contact: Alison Shea, MD
• Phone: 905-521-2100
• Email: ashea[@]stjosham.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood (depression and anxiety) in peri- and early menopausal women.

Description:

During the transition to menopause, women are at risk for developing symptoms of depression and anxiety, and impaired sleep. Fluctuation in estrogen levels appears to play a role in this. The investigators suspect that the administration of estrogens without progesterone, such as conjugated estrogens/ bazedoxifene (CE/ BZA), may improve mood symptoms in this population. In 2017, CE/ BZA was approved for menopausal vasomotor symptoms (VMS) in Canada, but the effect on mood were not examined closely.

The investigators propose a pilot study of 30 peri- and early postmenopausal women, currently seeking treatment for symptoms of depression or anxiety. The participants will go through a round of treatment with CE/BZA. The study will last 16 weeks. The study's objectives are to determine primarily if CE/BZA improves mood among peri- and early postmenopausal women, and secondarily if treatment with CE/BZA improves their sleep.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

Inclusion Criteria:

• Females between 45-60 years of age

• Able to communicate in English

• In perimenopause as defined by World Health Organization (WHO) STages of Reproductive Aging Workshop (STRAW) criteria, OR in early menopause (within 10 years of final menstrual period)

• Suffering from Depressive symptoms (16+ on CES-D) AND/OR anxiety symptoms (10+ on GAD-7)

Exclusion Criteria:

• Personal history of breast/ ovarian/ endometrial cancer/ endometrial hyperplasia.

• Abnormal uterine bleeding that has not been adequately investigated.

• Active or past venous or arterial thromboembolic disease (deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, coronary heart disease).

• Active liver disease.

• Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders.

• Known or suspected pregnancy, women who may become pregnant, and nursing mothers

• Partial or complete loss of vision due to ophthalmic vascular disease.

• Uncontrolled hypertension (Systolic blood pressure >160mm Hg and/ or diastolic blood pressure >95 mm Hg)

• Other endocrine disease that may adversely affect mood: uncontrolled thyroid disease, Cushing's disease, Addison's disease, hyperparathyroidism. For women with abnormal thyroid stimulating hormone (TSH), it will be corrected in advance of trial initiation.

• Active serious suicidal ideation with intent.

• Regular treatment with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor within 2 months before screening visit

• Use of other psychoactive or centrally acting medications within 2 weeks before study screening

• Known hypersensitivity to either CE or BZA.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression, Anxiety
• Menopause
• Sleep

Intervention

Drug:
• Duavive 0.45Mg-20Mg Tablet
Duavee, marketed as Duavive in Canada.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	McMaster University, Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms	Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D). Scores from 0-60, with higher scores indicating higher levels of depression.	At 4 weeks weeks after beginning study
Primary	Depressive symptoms	Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D). Scores from 0-60, with higher scores indicating higher levels of depression.	At 8 weeks after beginning study
Primary	Depressive symptoms	Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D). Scores from 0-60, with higher scores indicating higher levels of depression.	At 12 weeks after beginning study
Primary	Depressive symptoms	Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D). Scores from 0-60, with higher scores indicating higher levels of depression.	At 16 weeks after beginning study
Primary	Depressive symptoms	Assessed by scores on the Montgomery-Asberg Depression rating Scale (MADRS). The scores range from 0-60, with higher scores indicating higher levels of depression.	At 4 weeks after beginning study
Primary	Depressive symptoms	Assessed by scores on the Montgomery-Asberg Depression rating Scale (MADRS). The scores range from 0-60, with higher scores indicating higher levels of depression.	At 8 weeks after beginning study
Primary	Depressive symptoms	Assessed by scores on the Montgomery-Asberg Depression rating Scale (MADRS). The scores range from 0-60, with higher scores indicating higher levels of depression.	At 12 weeks after beginning study
Primary	Depressive symptoms	Assessed by scores on the Montgomery-Asberg Depression rating Scale (MADRS). The scores range from 0-60, with higher scores indicating higher levels of depression.	At 16 weeks after beginning study
Primary	Anxiety symptoms	Assessed by scores on the Generalized Anxiety Disorder Scale (GAD-7). The scores range from 0-21, with higher scores indicating higher levels of anxiety.	At 4 weeks after beginning study
Primary	Anxiety symptoms	Assessed by scores on the Generalized Anxiety Disorder Scale (GAD-7). The scores range from 0-21, with higher scores indicating higher levels of anxiety.	At 8 weeks after beginning study
Primary	Anxiety symptoms	Assessed by scores on the Generalized Anxiety Disorder Scale (GAD-7). The scores range from 0-21, with higher scores indicating higher levels of anxiety.	At 12 weeks after beginning study
Primary	Anxiety symptoms	Assessed by scores on the Generalized Anxiety Disorder Scale (GAD-7). The scores range from 0-21, with higher scores indicating higher levels of anxiety.	At 16 weeks after beginning study
Secondary	Menopause symptoms	Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.	At 4 weeks after beginning study
Secondary	Menopause symptoms	Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.	At 8 weeks after beginning study
Secondary	Menopause symptoms	Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.	At 12 weeks after beginning study
Secondary	Menopause symptoms	Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.	At 16 weeks after beginning study
Secondary	Total nightly sleep time	Assessed by an Actigraph 2 monitor	At 4 weeks after beginning study
Secondary	Total nightly sleep time	Assessed by an Actigraph 2 monitor	At 8 weeks after beginning study
Secondary	Total nightly sleep time	Assessed by an Actigraph 2 monitor	At 12 weeks after beginning study
Secondary	Total nightly sleep time	Assessed by an Actigraph 2 monitor	At 16 weeks after beginning study
Secondary	Sleep onset latency	Assessed by an Actigraph 2 monitor	At 4 weeks after beginning study
Secondary	Sleep onset latency	Assessed by an Actigraph 2 monitor	At 8 weeks after beginning study
Secondary	Sleep onset latency	Assessed by an Actigraph 2 monitor	At 12 weeks after beginning study
Secondary	Sleep onset latency	Assessed by an Actigraph 2 monitor	At 16 weeks after beginning study
Secondary	Wake after sleep onset	Assessed by an Actigraph 2 monitor	At 4 weeks after beginning study
Secondary	Wake after sleep onset	Assessed by an Actigraph 2 monitor	At 8 weeks after beginning study
Secondary	Wake after sleep onset	Assessed by an Actigraph 2 monitor	At 12 weeks after beginning study
Secondary	Wake after sleep onset	Assessed by an Actigraph 2 monitor	At 16 weeks after beginning study