Affect of Duavive on Mood & Anxiety Symptoms

Launched by ST. JOSEPH'S HEALTHCARE HAMILTON · Jul 15, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called conjugated estrogens/bazedoxifene (CE/BZA) on mood, particularly focusing on symptoms of depression and anxiety in women who are experiencing menopause. The aim is to see if this treatment can help improve mood in women who are going through perimenopause or early menopause, which can often bring about mood changes and other related symptoms.

To participate in the trial, women aged between 45 and 60 who are experiencing depressive or anxiety symptoms may be eligible. However, certain health conditions would exclude someone from participating, such as a history of specific cancers or serious blood clotting disorders. If you join the study, you will receive the medication and be monitored for its effects on your mood and anxiety levels. This trial is currently looking for participants, and it’s a chance to contribute to research that could help many women facing similar challenges during menopause.

Gender

FEMALE

Eligibility criteria

• 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.