Affect of Duavive on Mood & Anxiety Symptoms

Phase 1RecruitingNCT04478305

St. Joseph's Healthcare Hamilton30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Menopause Depression, Anxiety Sleep Menopause Related Conditions

Interventions

Duavive 0.45Mg-20Mg TabletDRUG

Duavee, marketed as Duavive in Canada.

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 60 Years

Medical Language ↔ Plain English

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 (10+ on CES-D-10) 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) * Endocrine disease (other than thyroid disease) that may adversely affect mood (i.e., Cushing's disease, Addison's disease). For women with abnormal TSH, it will be corrected in advance of trial initiation. * Active serious suicidal ideation with intent. * Symptoms of active psychosis. * Daily use of antidepressive medication. * Use of other psychoactive or centrally acting medications within 2 weeks before study screening. * Known hypersensitivity to either CE or BZA.

Locations (1)

St Joseph's Healthcare

Hamilton, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

Depressive symptoms

Assessed by scores on the Center for Epidemiologic Studies Depression Scale (CES-D=10). Any score that is equal to or higher than 10 is considered depressed.

Time frame: At 4 weeks weeks after beginning study

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.

Time frame: At 8 weeks after beginning study

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.

Time frame: At 12 weeks after beginning study

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.

Time frame: At 16 weeks after beginning study

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.

Time frame: At 4 weeks after beginning study

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.

Time frame: At 8 weeks after beginning study

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.

Central Contacts

Alison Shea, MD

CONTACT

905-521-2100 ashea@stjosham.on.ca

Leticia Hernandez Galan, PhD

CONTACT

2897001324 lgalan@stjosham.on.ca

Data from ClinicalTrials.gov

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Secondary Outcomes

Menopause symptoms

Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.

Time frame: At 4 weeks after beginning study

Menopause symptoms

Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.

Time frame: At 8 weeks after beginning study

Menopause symptoms

Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.

Time frame: At 12 weeks after beginning study

Menopause symptoms

Assessed by the Greene Climacteric Scale (GCS). Scores range from 0-21, with higher scores indicating more severe menopausal symptoms.

Time frame: At 16 weeks after beginning study

Total nightly sleep time