Effects of a Tissue Selective Estrogen Complex (TSEC) on Depression and the Neural Reward System in the Perimenopause"

NCT03740009 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 18-2129
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Using neuroimaging, the investigator will study the effects of estrogen on mood and brain function in perimenopausal women with depression.

Conditions

Perimenopausal Disorder; Depression

Keywords

Hormone Replacement Therapy; Estrogen; Depression; Mood Disorders; Estrogen Replacement Therapy; Depressive Disorder; Mental Disorders; Hormones; Physiological effects of drugs; Reproductive Control Agents; Tissue Selective Estrogen Complex

Outcome Measures

Primary Outcomes (2)

• Change in Frontostriatal Reactivity to Reward During MID fMRI Task

  The primary outcome measure is functional magnetic resonance imaging (fMRI) data collected during a Monetary Incentive Delay (MID) Task. All participants will complete the fMRI Monetary Incentive Delay (MID) task at baseline and at 3 weeks. During the task, participants need to select the correct response during "win" and "lose" conditions by pressing a button on a button box in the MRI. Participant's blood-oxygen-level dependent (BOLD) activation response (A measurement of oxygen level that is released to neurons since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen to perform the tasks.) is measured while they performed the task in MRI scanner.

  Baseline to 3 weeks

• Depressive Symptoms as Measured by the MASQ-AD

  The second primary outcome measure uses the Mood and Anxiety Symptoms Questionnaire - Anhedonic Depression Scale (MASQ-AD) to examine symptom change. All participants will complete the MASQ-AD at each study visit, which measures their current symptoms of depression and anxiety. Scores range from 22 to 110 with lower scores reflecting a better outcome.

  Baseline, week 2, week 3, week 4 (post treatment)

Study Arms (1)

Perimenopausal women, depressed

EXPERIMENTAL

Participants will take Bazedoxifene/Conjugated Estrogen orally for 3 weeks

Drug: Bazedoxifene/Conjugated Estrogen

Interventions

Bazedoxifene/Conjugated Estrogen DRUG

20 mg bazedoxifene/0.45mg conjugated estrogens tablets

Also known as: Duavee

Perimenopausal women, depressed

Eligibility Criteria

• Age: 44 Years - 55 Years
• Gender Eligibility Details: Men will not be included in this study, given the stated purpose of studying hormone therapy in perimenopausal women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• \* Per the STRAW criteria, FSH values are highly variable in the late menopausal transition (stage -1), and clinicians should "carefully evaluate the appropriate FSH value, depending on the assay they use" (Harlow et al, 2012). For nearly two years following the LMP, FSH values can fluctuate between levels characteristic of the early reproductive years and levels characteristic of menopause (Hale et al, 2014). McLendon Labs at the University of North Carolina at Chapel Hill (UNC) uses an FSH assay that defines levels consistently above ? 21.5 IU/mL as post-menopausal (McLendon Labs, 2016). As FSH values do not stabilize at consistently high levels until post-menopause, the investigators are setting our minimum required FSH value at \> 14 IU/mL to carefully select for women in the perimenopause transition.
• Patients will not be permitted to enter this protocol if they have any of the following:
• current medication use (i.e., psychotropics, anti-hypertensives, statins, hormonal preparations, or frequent use of anti-inflammatory agents (\> 10 times/month)). Women will be allowed to enroll who take medications without known mood effects (e.g. stable thyroid hormone replacement and occasional (\< 5 times/month) use of Ambien);
• all reported prescription medications will be reviewed and cleared by a study physician prior to a participant's enrollment;
• pregnant, breastfeeding or trying to conceive;
• LMP more than 12 months prior to enrollment;
• women who have recently taken oral contraceptives continuously for relief of perimenopausal symptoms will be exempt from the final menstrual period (FMP) criteria, and instead, the presence of menstrual irregularity prior to the use of oral contraceptives and elevated FSH will be used to determine their perimenopausal status;
• history of undiagnosed vaginal bleeding;
• undiagnosed enlargement of the ovaries;
• polycystic ovary syndrome;
• history of breast or ovarian cancer;
• first degree relative with ovarian cancer;
• first degree relative with premenopausal onset or bilateral breast cancer;
• + first degree relatives with breast cancer (regardless of onset);
• + relatives with postmenopausal breast cancer;

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Foundation of Hope, North Carolina: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill School of Medicine

Chapel Hill, North Carolina, 27514, United States

Location

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MeSH Terms

Conditions

Depression; Mood Disorders; Depressive Disorder; Mental Disorders

Interventions

bazedoxifene; Estrogens, Conjugated (USP)

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Crystal Schiller, PhD
• Organization: UNC School of Medicine

crystal_schiller@med.unc.edu

919-966-4810

Study Officials

• Crystal E Schiller, PhD

  UNC Dept of Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 14, 2018
• Study Start: January 2, 2019
• Primary Completion: May 17, 2021
• Study Completion: May 17, 2021
• Last Updated: May 10, 2022
• Results First Posted: May 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)